Bulletin of Experimental Treatments for AIDS, No. 31, December 1996
Leslie Hanna

For further information about individual listings, call the number provided or call the AIDS Clinical Trials Information Service (ACTIS) toll-free at 800-874-2572 (800-TRIALS-A). ACTIS has information about all government-sponsored trials (e.g., all trials designated with an ACTG or FDA number) and most trials that are being conducted at multiple sites.

Treatment For HIV Infection

Alpha interferon

DATRI 022 is a multicenter, prospective trial that will compare the efficacy of 3 different types of low-dose oral alpha interferon (Alferon LDO, Veldona, Ferimmune) in 560 people with 50-350 CD4 cells/mm3. Participants will be randomized to receive one of the 3 formulations or placebo, and may continue taking antiretroviral therapy and prophylaxis against opportunistic infections (OI). Treatment lasts for 6 months, with monthly exams. For information about sites (in CA, NY, TN, MI, PA, MN and Washington, DC) call 800-TRIALS-A.

AZT/3TC plus d4T or delavirdine

Intercompany Collaboration (ICC) protocol number 003 will evaluate the safety and efficacy of combination AZT and 3TC plus either d4T or delavirdine in 150 people with 500 or more CD4 cells/mm3. ICC 003 is a multicenter study that will last for approximately 1 year. Eligible participants are antiretroviral-naive (i.e., have never before used any antiretroviral drugs) and have detectable viral load. Participants will be randomized to receive AZT/3TC plus d4T, or AZT/3TC plus delavirdine. Plasma HIV levels will be monitored. In the San Francisco (SF) Bay Area, call Debbie Slamowitz at the AIDS Community Research Consortium (ACRC) at 415-364-6563. For other sites and information call the ICC Clinical Coordinating Center from 9am to 5pm, Eastern Standard Time, at 800-925-AIDS.

AZT, 3TC and delavirdine

This 2-year study will compare the safety and efficacy of different combinations of these 3 drugs. Participants will be randomized to receive either combination AZT/3TC, AZT/delavirdine or AZT/3TC/delavirdine. The study is open to people with 200-500 CD4 cells/mm3, no more than 6 months total prior treatment with AZT and no history of pancreatitis. In the SF Bay Area, call ViRx at 415-353-5623.

Bis-POM PMEA

At multiple sites, FDA 232C will evaluate the efficacy of supplementing a participant s current antiretroviral regimen with bis-POM PMEA (adefovir dipivoxil), also called just PMEA. The 48-week study will randomize participants to receive supplemental PMEA or placebo for the first 24 weeks, after which everyone will receive open-label PMEA. The study is open to those with 200 or more CD4 cells/mm3 and a viral load greater than or equal to 2,500 copies/mL who have been on their current antiretroviral regimen for at least 2 months. In the SF Bay Area call Anna Smith at San Francisco General Hospital (SFGH) at 415-476-4082 x84098, Brian Camp at ACRC at 415-364-6563 or Nancy Orcutt at the East Bay AIDS Center at 510-204-1870.

1592U89 and other nucleoside analogs

Glaxo Wellcome is sponsoring a nationwide trial of the nucleoside analog 1592U89 in combination with background nucleoside analog therapy. All participants will receive 300 mg 1592U89 twice daily, in addition to AZT, 3TC, ddI and/or d4T. Participants must have 100 or more CD4 cells/mm3 and a viral load of at least 30,000 copies/mL. Prior use of any protease inhibitor or non-nucleoside reverse transcriptase inhibitor is prohibited, and there are specific requirements about the extent of prior nucleoside analog use. There are 3 CA sites, 2 FL sites, and one site in GA, KY and NY. In the SF Bay Area, call Debbie Hildebrandt at ViRx at 415-353-5623.

PMPA

This Phase I/II double-blind study of the safety, tolerance, pharmacokinetics and antiviral potential of PMPA is the first study of the drug in humans. Manufactured by Gilead Sciences, PMPA is a nucleotide analog that, in animal studies, prevented infection with simian immunodeficiency virus (SIV). The drug takes 1 hour to administer by intravenous infusion. Participants will be randomized to receive 1 of 4 doses of PMPA or placebo. Participants must have 200 or more CD4 cells/mm3, a viral load equal to or greater than 10,000 copies/mL and must not be taking antiretroviral therapy or a number of other drugs. For more information call Anna Smith, RN, at SFGH at 415-476-9296 x313.

Treatment for Opportunistic Infections

Cryptosporidiosis: azithromycin

FDA 058J provides oral and intravenous (IV) azithromycin to people with proven cryptosporidiosis that persists or has progressed despite prior therapy. IV treatment is for people whose persistent diarrhea requires IV fluids to maintain hydration. People who do not respond to oral azithromycin within 2-4 weeks also may try the IV formulation.

Cryptosporidiosis: BIC-C. parvum

GalaGen, manufacturer of BIC-C. parvum (bovine immunoglobulin concentrate-Cryptosporidium parvum), has announced expanded clinical trials. The company will also make screening kits for diagnosing C. parvum available to patients and physicians at no charge. This Phase II/III study will randomize participants with cryptosporidiosis-related chronic diarrhea to receive 4 daily doses of a powder formulation of BIC-C. parvum or placebo for 35 days. Cryptosporidiosis must be diagnosed by stool or biopsy culture, and participants must have diarrhea. Participants also must have 180 or fewer CD4 cells/mm3 and must not have active cytomegalovirus (CMV) colitis. There are multiple sites around the country. For more information about the trial or screening kits, call 800-372-AIDS (2437) or visit the trial web site.

Histoplasmosis: AmBisome and amphotericin B

This Phase IIB study will compare the safety and efficacy of AmBisome and conventional amphotericin B for treating disseminated histoplasmosis in people with AIDS. AmBisome is a new liposomal formulation of amphotericin B, the gold standard for treating systemic fungal infections. Unfortunately, treatment with amphotericin B often involves a high level of toxicity. People with AIDS and moderate to severe disseminated histoplasmosis will be randomized to receive 3.0 mg/kg/day AmBisome or 0.7 mg/kg/day amphotericin B for 2 weeks. Since these drugs are being evaluated for induction therapy, people who respond well clinically may stop after 7 days. All participants will be observed daily and evaluated twice weekly. After the second week, all subjects will also receive itraconazole. Exclusion criteria include history of allergy to amphotericin B and other acute, uncontrolled OI. In the SF Bay Area call Edwin Graham, RN, at 415-476-9296 x304.

Multiple OI prophylaxis: drug interactions

The objective of ACTG 283 is to gather data on the interactions between various drugs that may be used simultaneously by persons with HIV to prevent multiple OI. Specifically, the study will determine the effects of fluconazole (Diflucan) and either rifabutin (Mycobutin) or clarithromycin (Biaxin), alone or in combination, on the pharmacokinetics of trimethoprim-sulfamethoxazole (TMP-SMX [Bactrim, Septra]) and then dapsone. The study has several parts, involving different combinations of the drugs. Participants will be followed every 2 weeks. The study is open to people with 200 or more CD4 cells/mm3 and no active OI requiring treatment. Antiretroviral therapy is allowed, as long as it has been in place for at least 1 month prior to the study's beginning. There are numerous restrictions on which medications may or may not be used before the study begins. Call 800-TRIALS-A for information about these restrictions and about specific sites.

Mycobacterium avium complex disease: 3 clarithromycin-containing regimens

ACTG 223 is a Phase II/III trial comparing the safety and efficacy of 3 regimens for treating disseminated Mycobacterium avium complex (MAC). Prior to randomization, participants will be stratified according to prior MAC prophylaxis, and all participants will receive clarithromycin for the first 72 hours to gauge individual response. The 3 study groups will receive 500 mg twice daily clarithromycin combined with either 450 mg oral rifabutin once daily or 15 mg/kg oral ethambutol or both rifabutin/ethambutol. A pharmacology substudy (ACTG 824) and a substudy for a new diagnostic test for MAC (ACTG 865) also will be conducted within the larger study. Participants must have either symptomatic MAC disease, a blood culture positive for M. avium within the previous 90 days, or symptomatic MAC plus a positive culture from another sterile site and a positive baseline blood culture. Exclusion criteria include current use of terfenadine (Seldane) or astemizole (Hismanal) and active non-MAC mycobacterial infection (e.g., tuberculosis). In the SF Bay Area, call David Gary, RN, at SFGH at 415-476-9296 x84095.

Toxoplasmic encephalitis: atovaquone, pyrimethamine and sulfadiazine

ACTG 237 is a Phase II open-label trial of 2 regimens for the treatment of acute toxoplasmic encephalitis. The standard combination therapy, pyrimethamine plus sulfadiazine, can be very toxic. Participants will be randomized to receive either atovaquone plus pyrimethamine or atovaquone plus sulfadiazine for up to 48 weeks. Participants with a history of problems with pyrimethimine or sulfadiazine will receive atovaquone plus the other, nonproblematic drug or atovaquone plus clarithromycin. All persons taking pyrimethamine will also receive leucovorin.

Toxoplasmic encephalitis: azithromycin

FDA 058A provides azithromycin to treat toxoplasmic encephalitis in people who have failed on or cannot tolerate conventional therapies.

Treatment for Malignancies and Cancers

Kaposi's sarcoma: calciprotriene

This 12-week study in Los Angeles (LA) will evaluate the efficacy for Kaposi's sarcoma (KS) lesions of topical applications of calciprotriene, a drug already approved for the treatment of psoriasis. Participants must have had at least 4 lesions on their arms, legs or trunk for at least 4 weeks, and no previous chemotherapy. Call Jacqui Pitt at Cedars-Sinai at 310-855-3755.

Kaposi's sarcoma: etoposide

ACTG 269 is an open-label Phase II study of the safety and efficacy of low-dose oral etoposide for the treatment of KS that has relapsed or progressed despite systemic chemotherapy. The starting dose is 50 mg/day of etoposide, to be taken daily for 1 week, followed by 1 week off. Doses will be increased for those who do not respond fully but do not have a significant toxic reaction. The study is open to HIV positive people aged 12 and older with biopsy-proven KS that has progressed after prior chemotherapy. Prior etoposide therapy and peripheral neuropathy greater than grade 3 are not permitted. In the SF Bay Area, call Penny Mason at SFGH at 415-476-4082 x84615.

Kaposi's sarcoma: liarozole (men only)

This Phase II study of liarozole is the first study of the drug for KS. Liarozole is an investigational drug being studied for the treatment of several types of cancer. During the 48-week, open-label study, doses will be escalated from 150 mg twice daily to 300 mg twice daily. The study is open to men aged 18 or older with biopsy-proven mucocutaneous KS and at least 1 lesion that has not been previously treated with local therapy. Because liarozole was associated with polycystic ovaries in prior animal studies, this study is not enrolling women. Exclusion criteria include previous systemic KS chemotherapy, active systemic infections and pulmonary KS. In the SF Bay Area, call Dorie Heeren, RN, at SFGH at 415-476-9296 x305.

Non-Hodgkin's lymphoma: topotecan HCL

This Phase II open-label study will evaluate the safety and efficacy of topotecan, a drug approved for treating recurrent ovarian cancer, as salvage therapy in people with HIV and non-Hodgkin's lymphoma (NHL). Every 21 days, participants will receive IV topotecan, administered over a 30-minute interval each day for 5 consecutive days The first part of the study will establish preliminary efficacy, and the next part will look at various measures like response rate, duration of response, time to response and time to progression. The study is open to HIV positive adults with biopsy-proven lymphoma at any stage. Antiretroviral therapy that has been taken for at least 2 weeks before the study begins is permitted, and must continue throughout the study. Prophylaxis for OI is also permitted. Call Dorie Heeren, RN, at SFGH at 415-476-9296 x305.

Primary CNS lymphoma: mitoguazone and radiotherapy

This study of mitoguazone (MGBG) and radiotherapy is open to people with HIV, fewer than 100 CD4 cells/mm3 and primary central nervous system (CNS) lymphoma. The primary objective of the study is to gauge the treatment's efficacy by determining whether and how well MGBG crosses the blood-brain barrier. Call Joanne Schifflet at LAC-USC Norris at 213-226-4578.

AIDS Dementia Complex

Memantine

This 13-week study will evaluate the safety and tolerability of different doses of memantine, an investigational drug that may be used to treat dementia, in people with HIV. All participants receive active drug (i.e., not placebo). If the first dose is tolerated, participants will take memantine daily, with weekly increases in dosage. The study is open to people with fewer than 200 CD4 cells/mm3 who agree to limit alcohol use during the study. In SF, call ViRx at 415-353-5623.

1592U89 for AIDS dementia complex

This is a Phase III multicenter study of the safety and efficacy of 1592U89 in conjunction with other antiretroviral therapy for people with AIDS dementia complex (ADC), presumably caused by HIV infection of the brain. 1592U89 is a nucleoside analog that crosses the blood-brain barrier to penetrate the central nervous system. It also has strong antiviral capabilities, so it may be a better alternative than AZT, the main antiretroviral drug used to treat ADC. In many people, HIV develops resistance to AZT. This study, the first to test 1592U89 in people with ADC, will randomize participants to receive either 600 mg of 1592U89 or placebo twice daily. Participants must be on a stable antiretroviral regimen for at least 8 weeks prior to study entry, which they must continue with for the first 12 weeks of the study. After that, for the next 40 weeks, 1592U89 will be available on an open-label basis to those who are tolerating it well. In the SF Bay Area, call Edwin Graham, RN, at SFGH at 415-476-9296 x304.

Treatments for Wasting Syndrome

Cholestyramine for HIV-associated diarrhea

This study in SF will evaluate the utility of cholestyramine (Questran Light) in people with HIV and diarrhea. Cholestyramine binds bile acids to enhance nutrient absorption by increasing the body's ability to absorb fat (the inability to absorb fat may be related to an inability to process bile acids, which then accumulate, spill into the large bowel and cause diarrhea.) Participants must have HIV and chronic diarrhea that has no identifiable, treatable cause but is associated with an inability to absorb fat and fails to respond to standard anti-diarrhea medications such as Lomotil. Call Amy Auslander at SFGH at 415-206-4746.

Deca durabolin and weight training (men only)

This study will evaluate the effect on lean body mass of combining 600 mg weekly deca durabolin and weight training in men without significant weight loss or OI. Participants will travel 3 times weekly to USC, east of downtown LA, for 12 weeks for training sessions with a personal trainer. Exclusion criteria include use of anabolic steroids or growth hormone in the past 6 months. Call Connie Olsen at 213-343-8288.

Megestrol acetate and testosterone

ACTG 313 is a double-blind Phase II trial of combination megestrol acetate (Megace) and testosterone for the treatment of HIV-related wasting. HIV-infected men and women with weight loss equaling at least 10% of normal body weight will be randomized to receive either the combination or megestrol acetate plus placebo. The trial will be conducted at sites around the country. In the SF Bay Area, call Carol Arri, RN, at 415-476-9296 x351.

Metoclopramidine for stasis dyspepsia

In SF, a study of metoclopramidine, FDA-approved for enhancing the stomach s ability to process foods and acids, will be evaluated for its utility in treating HIV positive people with nausea, vomiting and weight loss that may be due to irregular stomach activity (e.g., muscle contraction). Call Amy Auslander at SFGH at 415-206-4746.

Oxandrolone, testosterone and weight training (men only)

In SF, this study will determine whether combining oxandrolone (Oxandrin) with a formal resistance exercise training program and testosterone replacement therapy will increase lean body mass, nutritional status, strength and endurance. The study is open to men with involuntary weight loss who are on a stable medication regimen, have normal testosterone levels and do not currently use testosterone or anabolic steroids. All participants will work with a personal trainer 3 times a week and will receive intramuscular testosterone therapy, and will be randomized to receive either oral oxandrolone or placebo. During the final 3 months, all persons will receive open-label oxandrolone. Call the Western Human Nutrition Research Center at 415-556-2174.

Oxandrolone (men only)

In LA, this double-blind study will evaluate the safety and efficacy of oxandrolone for use by HIV positive men with unintentional weight loss of 10-20% normal body weight. Participants will be randomized to receive oxandrolone or placebo for the first 12 weeks; for the next 12 weeks, all participants will receive open-label oxandrolone. All participants will receive nutritional information. Exclusion criteria include dementia or malignancy other than KS. Call Jacqui Pitt at Cedars Sinai at 310-855-3755.

Ritonavir/saquinavir plus nucleoside analog therapy: effect on nutritional status

In SF, this study will evaluate the effects on CD4 cell count and nutritional status of adding combination ritonavir/saquinavir to current nucleoside analog therapy in persons who are protease inhibitor-naive. To determine nutritional impact, investigators will look at body composition, food intake, energy expenditure, fat and protein metabolism, and vitamin and mineral levels.The study is open to people with 50-350 CD4 cells/mm3, weight loss and viral load greater than 10,000 copies/mL who have never used any protease inhibitor. For 6 weeks, all participants will receive the combination protease inhibitors and will be randomized to receive a nutritional supplement or placebo. Open-label protease inhibitors will be provided free for the following 6 months. Call Becky Hoh at 415-476-3669 x1 or Dr. Marc Hellerstein at 415-206-5886.

Immune Enhancement

Recombinant human IL-12

ACTG 325 is a Phase I double-blind trial of the safety, tolerance and immune-enhancing potential of different doses of recombinant human interleukin 12 (rhIL-12) in 2 groups of people with HIV/AIDS: those with fewer than 50 CD4 cells/mm3 and those with 300-500 CD4 cells/mm3. All participants must be on a stable antiretroviral regimen and take PCP prophylaxis. Exclusion criteria include history of MAC disease, CMV end-organ disease, invasive fungal disease, history of toxic reactions to IL-2 or IL-12 and use of IL-12 within 24 weeks before the beginning of the study. The drug will be administered twice weekly by subcutaneous injection. In SF, call Carol Arri, RN, at SFGH at 415-476-9296 x351.

Recombinant human GM-CSF

This is a multicenter, double-blind Phase III trial of the immune-enhancing potential of recombinant human granulocyte macrophage colony-stimulating factor (rhu GM-CSF [Leukine]), used in addition to stable antiretroviral therapy, for people with advanced HIV disease. The study will specifically evaluate the impact of the treatment on the subsequent development of OI. Participants will receive 250 mcg of yeast-derived rhu GM-CSF or placebo 3 times weekly for 6-12 months.The study will enroll 500 people with 100 or fewer CD4 cells/mm3 and a history of AIDS-defining illness. All participants must be on a stable antiretroviral regimen which will continue throughout the study. Prophylaxis against OI and maintenance chemotherapy are permitted. In the SF Bay Area, call Brenda Cayme, RN, at 415-364-6563.

Hepatitis A vaccine

This double-blind, placebo-controlled study will determine the safety of a single dose of hepatitis A vaccine followed by a booster dose in people with HIV, and will also evaluate the effects on CD4 cell count and viral load. The study is open to people with HIV aged 19 years or older who are negative for hepatitis A antibodies and are on a stable antiretroviral regimen or take no antiretrovirals. Exclusion criteria include active OI, use of immunotherapy and a history of hemophilia. In SF, call ViRx at 415-353-5623.

Children and Adolescents

Accessing experimental therapies not in pediatric trials

Although most adult studies are open only to persons over the age of 18 years, several adult studies now also include adolescents aged 13-17. Representatives at 800-TRIALS-A can identify which adult studies permit adolescents.

HIV infection: d4T and ddI

A Phase II study, ACTG 327 is a rollover protocol for children involved in ACTG 240. Children who have been taking d4T will be switched to d4T plus ddI, and children who have been taking AZT monotherapy will be randomized in a blinded fashion to receive either d4T or d4T plus ddI. Children will continue on the newly assigned regimen for 48 weeks. Investigators will evaluate the comparative safety and efficacy of the different regimens by looking at short-term and long-term changes in viral load. The study is open to children aged 6 months to 10 years, with any CD4 count, who were receiving treatment per ACTG 240 or on AZT monotherapy for 6 months before beginning ACTG 327.

HIV infection: AZT and ddI

This study, ACTG 329, has been amended several times. As it now stands, it is a Phase I/II study of the pharmacokinetics, safety and efficacy of ddI alone or in combination with AZT in infants. Currently, the study is seeking participants younger than 90 days old who will be randomized to receive ddI or ddI plus AZT. Participants must have either documented HIV infection by HIV culture or PCR, or must have an HIV positive mother and must be taking AZT. Infants also must be clinically stable and free of pancreatitis.

Measles vaccination

ACTG 225 is a Phase II study that compares the effects of 2 immunization schedules. One schedule gives attenuated measles/mumps/rubella virus vaccine (MMR II) at 12 months and the other gives an attenuated measles vaccine (Attenuvax) at 6 months plus the MMR II at 12 months. Children will be randomized to receive one of the 2 vaccination schedules, then will be followed for 24 months after the last vaccination. At 12 months of age, level of measles antibodies will be measured in both groups of children.

Pediatric "late outcomes"

ACTG 219 is a longitudinal study of HIV disease and treatment effects in children and adolescents. The study is open to HIV positive children of all ages who are or were enrolled in pediatric ACTG trials or who are the children (including those with indeterminate HIV status) of women who were enrolled in ACTG trials while pregnant. A main objective of the study is to determine the effects over time of antiviral treatment, received after birth or in utero, in children who are still growing. To gather data, children will have a complete physical exam and other assessments (e.g., neurologic exam) at regular intervals (every 6 months for children younger than 3 years, and every 12 months for children older than 3). Various tests including laboratory blood tests and urinalysis will be performed regularly. The study will last until the child turns 21 or is lost to follow-up.

Women

5-fluorouracil for high-grade cervical dysplasia

ACTG 200 is a Phase III trial of 5-fluorouracil (5-FU) vs observation in HIV positive women who have already been treated for high-grade cervical dysplasia. Participants will be randomized to receive 5-FU, in a self-administered intravaginal cream, or no treatment for 6 months. All participants will be evaluated for recurrent dysplasia by Pap smear and colposcopy and, if necessary, biopsy. Participants must have a history of grade II or III cervical intraepithelial neoplasia (CIN) that was succesfully treated by laser therapy, cryotherapy, loop excision or cone biopsy within the past 12 weeks. Exclusion criteria include use of 5-FU or the existence of a malignancy requiring chemotherapy within 3 months prior to the study.

Megestrol acetate oral suspension for wasting

FDA 025C is a Phase IV study of megestrol acetate oral suspension in women with HIV wasting syndrome, defined as poor appetite and weight loss greater than or equal to 10% of pre-illness body weight. Participants will be randomized to receive 400 or 800 mg megestrol acetate daily for 24 weeks. Those taking 400 mg daily who have not gained 5 pounds or have not experienced any appetite improvement by week 12 can increase their dose to 800 mg daily. All participants will be evaluated at 4-week intervals.

Nandrolone decanoate for wasting

ACTG 329 is a double-blind Phase I/II trial of nandrolone decanoate vs placebo in women with HIV-associated weight loss. The study is open to HIV-infected women with weight loss greater than or equal to 5% of normal body weight. In the SF Bay Area, call Carol Arri, RN, at 415-476-9296 x351.

Oxandrolone for wasting

This multicenter, Phase III trial will assess the safety and efficacy of 2 doses of oxandrolone in women with HIV-related weight loss. The first of the 2 phases of the study consists of 12 weeks of randomized treatment with either of 2 doses (20 and 40 mg daily) of oxandrolone or placebo. During the second 12-week phase, all participants will receive 20 mg daily oxandrolone. Efficacy will be measured by body weight changes and bioelectrical impedance analysis (BIA). At selected centers, a substudy will evaluate the effect of oxandrolone on protease inhibitor levels. The study is open to women who have lost 10-20% of their normal body weight, but not greater than 5% during the month prior to joining the study. There are multiple sites in New York City, and single sites in Newark, Washington, DC, Baltimore, Philadelphia, Sarasota, Tampa, Miami and Los Angeles. In LA, call Heather Churchill at the AIDS Healthcare Foundation (AHF) at 213-913-3953. For information about specific sites, call Dr. Henny or Lisa Salerno at Biotechnology General Corporation at 908-632-8800.

Perinatal transmission of AZT-resistant HIV

ACTG 255 is a prospective study of perinatal HIV transmission (PHT) among pregnant women treated with AZT. Specifically, patterns of HIV susceptibility and resistance to AZT among mother/child pairs will be studied and identified. HIV positive pregnant women will be enrolled at 20-36 weeks gestation. Mothers will have blood drawn for HIV culture at study entry and at delivery; babies will have blood drawn for culture at delivery and at 1, 3, 6 and 18 months of age. Inclusion criteria for women include CD4 count equal to or lower than 300 CD4 cells/mm3 within 28 days before study entry, 13 years of age or greater, at least 6 months of previous AZT use, and continuing AZT use during the current pregnancy. Use of antiretrovirals other than AZT is prohibited.

Miscellaneous

Acupuncture and herbal treatment for chronic HIV-related sinusitis

In SF, FDA 243A will compare 2 approaches to treating chronic sinusitis. Participants will be randomized to receive either the Traditional Chinese Medicine treatment, consisting of acupuncture and herbal treatment, or the standard Western antibiotic treatment, consisting of pseudoephedrine (Sudafed) plus amoxicillin/clavulanate potassium (Augmentin). Treatment will be given for 8 weeks, and final evaluation will occur at week 12. All particpants will undergo an endoscopic nasal exam and CT scan of the paranasal sinuses at entry and at week 12. Call Tom Sinclair at the Immune Enhancement Project at 415-252-8711.

Acyclovir for herpes simplex virus: effect on HIV viral load

DATRI 020 is a pilot study that will evaluate the impact of herpes simplex virus (HSV) suppression with acyclovir on HIV viral load in people with asymptomatic HSV infection who are at risk for reactivation. In the first part of the study, participants will be randomized to receive acyclovir or placebo for 12 weeks. Clinical exams will be conducted on a regular basis. In the second part, people with an HSV outbreak will be treated with acyclovir. The study is open to people with HIV, fewer than 250 CD4 cells/mm3 within a month before study entry, documented HSV (1 or 2) antibodies and a history of an HSV outbreak within 2-12 months prior to study entry. Those in part 2 must also have an active HSV outbreak.

Chinese antiviral herbs

In LA, this study will evaluate the antiviral potential of 5 different Chinese herbal formulations, along with acupuncture. The study is open to people with 300-500 CD4 cells/mm3 and no OI, who are either not taking any antiretroviral drugs, herbs or HIV-related treatments or are willing to suspend treatment for 30 days before the 24-week study begins, as well as throughout the study period. Call Jin Lin Wang or Neil Miller at the Oriental Medical Center at 310-888-1108.

Famciclovir for recurrent genital herpes

This open-label multicenter study will assess the safety and efficacy of oral famciclovir (approved for treating herpes zoster and recurrent genital herpes in HIV negative people) in HIV positive people with recurrent genital herpes. All participants will receive 500 mg famciclovir twice daily for 4 months. Participants must have an active genital herpes outbreak and a positive HSV culture at screening, but must not have used any anti-herpes agent within 14 days prior to screening. In the SF Bay Area, call Dorie Heeren, RN, at 415-476-9296 x305.

Clinical Trials Information by Region

Trials Search Guide to HIV Clinical Trials in California (Northern and Southern California editions available) 800-492-5777; in Northern California: 415-476-5777 http://galen.library.ucsf.edu/aids/trials.html

New York, Connecticut, New Jersey and Philadelphia 800-734-7104

AIDS Institute Experimental Treatment Infoline in New York state: 800-MEDS-4-HIV outside New York: 212-239-5523

Houston Calinical Trial Network 713-520-2083

AIDS Survival Project, Georgia and Alabama 404-874-7926

Community Research Initiative of South Florida, Inc. 305-667-9296

Gulf Coast Region 504-584-3605

AIDS/HIV Treatment Directory for New England 617-566-4004

Wisconsin AIDS Research Consortium in Wisconsin: 800-359-9272 outside Wisconsin: 414-225-1600

Canadian HIV Trials Network 604-631-5327

Actively Recruiting U.S. Trials AmFAR Treatment Directory: 212-682-7440

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