Bulletin of Experimental Treatments for AIDS, July, 1998
Katy Stephenson
This pilot study aims to determine if cannabinoids (chemicals contained in the marijuana plant) can alter viral load levels by affecting the body's ability to process antiretroviral medications. The study will also evaluate the short-term effects of cannabinoids on appetite, energy, body composition and body weight. If enrolled, participants will spend 25 days and nights in the hospital and will be assigned to smoke marijuana cigarettes, take dronabinol (Marinol) pills or take placebo pills. Participants will also continue their current antiretroviral regimens, which must include either indinavir (Crixivan) or nelfinavir (Viracept). To join, participants must have stable viral load levels but can have any CD4 cell count. Participants must have experience using marijuana, but cannot have smoked marijuana or tobacco during the month before joining the study. Participants cannot have any opportunistic infections or cancers and cannot be taking certain other medications. Participants will be paid $1,000 for completing the study, which is only offered in San Francisco. Call 415-502-5705. (CC038/GCRC531)
The purpose of this Phase I/II study is to evaluate the safety and activity of zintevir (AR177), an integrase inhibitor, in the body and on HIV and the immune system. All participants will receive zintevir at varying doses as an infusion into a vein once a day for 14 days. Participants will stay in the hospital for 20 days. Participants must have a CD4 cell count above 200 cells/mm3 and a viral load level above 4,000 copies/mL. Participants may not have any past or current AIDS-defining illness, abnormal bleeding tendencies, or have recently used any investigational drug, antiretroviral medications, monoamine oxidase (MAO) inhibitor or enzyme inducer. This study is offered only in New York City; call 212-746-4393. (FDA 290A)
The purpose of this study is to see if 1,200 mg of indinavir taken twice a day is as safe and effective in keeping viral load below 400 copies/mL as 800 mg of indinavir taken 3 times a day. Participants will receive 2 nucleoside analogs such as AZT or d4T, and will be randomized to receive 1 of the 2 doses of indinavir. The study lasts 24 weeks. Participants must have at least 100 CD4 cells/mm3 and a viral load above 400 copies/mL, and must currently be taking indinavir and 2 nucleoside analogs. Exclusions include the use of non-nucleoside reverse transcriptase inhibitors (NNRTI) such as delavirdine, and any other protease inhibitor besides indinavir. Other exclusions include active opportunistic infections or cancers requiring chemotherapy. The study is offered at many sites around the country; call 800-TRIALS-A for more information. (FDA 246M)
This study is designed for participants from under-represented populations (ethnic minorities, women and injection drug users). The purpose of the study is to see if an educational intervention program called Tools for Health and Empowerment (T.H.E.) can improve viral load, patient adherence to drug regimens, immunologic response and health outcomes. All participants will receive abacavir (Ziagen) and AZT/3TC (Combivir). Each participant will be assigned by chance to receive the T.H.E. program plus routine counseling, or to receive routine counseling alone. The T.H.E. program consists of a 2-hour class once a week for the first 4 weeks of the study, which lasts a total of 24 weeks. Participants must have a CD4 cell count greater than 50 cells/mm3 and a viral load between 40,000 and 100,000 copies/mL. Participants cannot have used any antiretroviral therapy for more than 6 months or ever have used AZT, 3TC, protease inhibitors, non-nucleoside reverse transcriptase inhibitors or abacavir. Exclusions include any AIDS-defining illness, or active or chronic hepatitis. This study is offered in Los Angeles; call 213-913-3953. (NZTA4006)
The purpose of this randomized, double-blind study is to evaluate the safety and effectiveness of MKC-422, a new NNRTI, when used in combination with d4T, ddI and hydroxyurea, a cellular inhibitor. Participants with a viral load between 5,000 and 50,000 copies/mL will be assigned to receive d4T, ddI and hydroxyurea plus either MKC-442 or placebo. All participants with a viral load level greater than 50,000 copies/mL will receive all 4 medications. Participants who receive placebo and experience less than a 1 log drop in viral load will be offered MKC-442. Participants can have any CD4 cell count, but must have a viral load of at least 5,000 copies/mL, and cannot have used any other NNRTI (such as nevirapine or delavirdine). Exclusions also include severe diarrhea, nausea, or an acute or clinically significant medical event within 30 days of study entry. The study lasts 48 weeks and is offered in San Francisco. Call 415-353-0800. (MKC-305)
The purpose of this Phase III, randomized study is to compare the safety and effectiveness of two 4-drug antiretroviral combinations with a 3-drug combination. All participants will receive AZT/3TC (Combivir) plus indinavir, and will be assigned by chance to take efavirenz (Sustiva), nelfinavir or nothing else. Participants must have a CD4 cell count below 200 cells/mm3 or a viral load level above 100,000 copies/mL. Exclusions include use of any protease inhibitors for more than 1 day, or use of 3TC or any NNRTI. This study lasts about 2 years and is offered at many sites throughout the country. Call 1-800-TRIALS-A for more information. (ACTG 388)
This study is intended for participants who are in the early stages of HIV disease. The purpose of this double-blind, placebo-controlled Phase II study is to evaluate the safety and impact of cyclosporin (CsA) on HIV viral load and CD4 cell counts. The study aims to determine if CsA can inhibit immune activation, thereby decreasing the rate at which CD4 T-cells are destroyed. Participants will be assigned at random to receive either placebo with no other medications, or CsA plus 2 nucleoside analogs. The study lasts 16 weeks. To join, participants must have a CD4 cell count greater than 500 cells/mm3 and a viral load above 600 copies/mL. Participants must either never have used antiretroviral medications or have been on a stable regimen including 2 nucleoside analogs for at least 8 weeks. Participants cannot have any past or current AIDS-defining conditions, or have ever used protease inhibitors or NNRTI. This study is offered at sites around the country; call 1-800-TRIALS-A for more information. (ACTG 334)
The purpose of this study is to evaluate the impact of low-dose interleukin-2 (IL-2), an immune modulator, on CD4 cell counts and viral load in participants taking highly active antiretroviral therapy (HAART). If enrolled, participants will either receive their current HAART regimen or the HAART regimen along with IL-2, which is given by injection under the skin once a day for the 6 months of the study. All participants will be offered an additional 6 months of HAART and IL-2 at the end of the study. Participants must have fewer than 200 CD4 cells/mm3 and a viral load below 10,000 copies/mL on 2 occasions within 6 months of study entry. Exclusions include any AIDS-defining illnesses (except minimal Kaposi's sarcoma), diabetes, cancers requiring chemotherapy and any prior use of IL-2. This study is offered in San Francisco only; call 415-353-0800. (MA9801)
This study aims to see if clinical practice that incorporates the use of the Antivirogram --- a phenotypic blood test that indicates resistance to certain drugs -- is an improvement over standard practice, in which decisions about changing antiretroviral therapy are made without reference to such a test. If enrolled, participants will be randomly assigned to have their treatment plans formed with the help of the Antivirogram, or based solely on the best clinical judgment of the treating physician without the help of an Antivirogram. All participants will receive Antivirograms; those assigned to have their treatment based on clinical judgement will not see the Antivirogram results until the end of the study, which lasts 16 weeks. Participants may have any CD4 cell count, but must have a viral load of at least 2,000 copies/mL. Participants must be on stable antiretroviral therapy and must have taken 1 protease inhibitor, but cannot have used any NNRTI or received prior phenotypic testing. Exclusions include any opportunistic infections, cancers requiring chemotherapy and peripheral neuropathy. This study is offered in San Francisco (call 415-565-6660) and other sites in the Bay Area, as well as in Los Angeles (call 213-913-3953) and Chicago (call 312-942-5000 ext.50486). Other sites are in Florida, Atlanta and Massachusetts. (VIRA3001)
The purpose of this study is to evaluate the safety and effectiveness of SU5416, an anti-tumor therapy, for the treatment of Kaposi's sarcoma (KS) of the skin. Participants will receive varying doses of SU5416 as an infusion into a vein twice a week for 4 weeks. Participants who respond well to SU5416 and do not experience any significant side effects will be offered SU5416 in 4-week cycles for up to 1 year. Participants may have any CD4 cell count or viral load level, but must have biopsy-proven KS of the skin and may not have any other cancers except basal cell carcinoma of the skin or cervical cancer. Participants may not have any current uncontrolled serious infections and must be on stable antiretroviral therapy for 6 weeks before the study. This study is offered in San Francisco; call 415-353-6215. (5416.003)
The purpose of this Phase II study is to evaluate the safety of OST 577, an antibody against hepatitis B, and to determine if OST 577 has any biological activity against hepatitis B in participants who are also infected with HIV. Participants will be randomly assigned to receive 1 of 2 doses of OST 577 or placebo. Participants will receive a total of 14 infusions of OST 577 over 6 months and will be paid $1,000 for completing the study. Inclusion criteria include a CD4 cell count of at least 200 cells/mm3 with any viral load. Participants must have documented hepatitis B infection, but cannot have any detectable hepatitis B antibodies or any other hepatitis (i.e., A or C) infection. Exclusions include any active cancers, active bacterial or systemic fungal infections and recent use of alpha interferon, interleukin-2, HBIG (hepatitis B antibodies) or any other experimental treatment. This study is offered in San Francisco; call 415-353-0800. (11-201)
This study aims to determine if valganciclovir, an oral prodrug of ganciclovir, is a safe and effective treatment for cytomegalovirus (CMV) retinitis. Everyone in this study will take valganciclovir as a pill after a meal, and will have study visits about once a month. The study lasts indefinitely. Entry criteria allow any CD4 cell count or viral load level, but participants must have CMV retinitis and have had at least 4 weeks of treatment with ganciclovir, foscarnet or cidofovir. Exclusions include severe, uncontrolled diarrhea and active CMV anywhere other than in the eyes. This study is offered in Irvine, CA (call 949-824-8303) and at multiple sites in the San Francisco Bay Area; one contact is 415-202-3981. Other sites include Chicago (call 312-633-5185) and New York (call 212-604-2684 or 212-737-7400). (WV15705)
This study evaluates the ability of an oral suspension of SCH 56592, an anti-fungal therapy, to eliminate oral and/or esophageal candidiasis (thrush). There is no placebo in this study, so all participants will receive SCH 56592, which is a liquid taken twice a day at first, and then once a day for 25 days. Participants may be required to undergo an esophagoscopy -- a procedure in which a tube is passed into the esophagus -- to confirm that they have thrush in the esophagus. If enrolled, after the first 5 weeks, participants will have study visits once a month for the next 4 months. To enroll, participants may have any CD4 or viral load level, but must have evidence of Candida in the mouth or esophagus at study entry. Participants must also have tried unsuccessfully to treat oral thrush with fluconazole or itraconazole, or have had esophageal thrush for more than 3 weeks. Participants cannot have started protease inhibitor therapy within 30 days of study entry, must have only perioral (around the mouth) lesions, and cannot have systemic fungal infections. This study is offered in Berkeley, CA (call 510-204-1291), Chicago (call 312-942-5865), Washington DC (call 202-745-0201) and Indianapolis (call 317-274-8456). (C97-330)
This is a pilot study to evaluate the role of d4T, a nucleoside analog, in the treatment of AIDS dementia complex (ADC). In particular, the study will look at the effect of d4T on ADC severity, as well as the drug's activity in the cerebrospinal fluid (CSF), including effect on CSF viral load. All participants will receive d4T, either as
an addition to their current antiretroviral regimen or as a replacement for AZT. The study lasts 12 weeks. Enrollees can have any CD4 cell count or viral load level, but must have ADC and must be on a stable antiretroviral regimen for at least 8 weeks. Participants cannot have taken d4T before, immunomodulators within 1 month of study entry, or certain other drugs. Exclusions include bilateral neuropathy, intractable diarrhea, any neurological disease unrelated to HIV infection and any active AIDS-defining opportunistic infections. This study is offered around the country; call 1-800-TRIALS-A for more information. (FDA 244E)
The purpose of this study is to determine if thalidomide has any effect on body composition in participants with HIV-associated wasting. There is no placebo in this study; everyone will receive thalidomide pills. The study lasts 24 weeks. Enrollees can have any CD4 count or viral load level, and must have wasting, defined as involuntary weight loss of more than 5% of pre-illness body weight. Due to the ability of thalidomide to cause birth defects, women who are capable of bearing children must either refrain from having sex or practice 2 forms of birth control during this study. Exclusions include active AIDS-defining opportunistic infections and severe peripheral neuropathy. This study is offered in Los Angeles (call 213-980-4466 ext. 245) and San Diego (call 619-235-4211). (W003)
The purpose of this study is to see how highly active antiretroviral therapy (HAART) including 1 protease inhibitor is processed by the bodies of pregnant women. Participants will spend one 8-hour day per trimester at the research clinic for multiple blood draws, and will be in the study for the duration of pregnancy. Enrollees can have any CD4 count or viral load level, but must have been pregnant for at least 6 weeks and must be on a stable HAART regimen that includes at least 1 protease inhibitor. This study is offered in San Francisco; call 415-476-6870.
This study is intended for infants and children with advanced HIV infection and limited treatment options. The study will provide all participants with access to abacavir, and will track the safety and effectiveness of abacavir for the reduction of viral load. Participants will remain in the study until their doctors feel abacavir is no longer beneficial or until abacavir is FDA-approved for use in infants and children. Participants must be between 6 months and 14 years old and have a CD4 cell percentage less than 15% of total lymphocytes. Participants must have a viral load greater than 30,000 copies/mL, or must have encephalopathy despite 4 weeks of antiretroviral therapy, or must have had side effects related to AZT, 3TC or ddI. Exclusions include severe liver or kidney disease. Participants must be ineligible for all other pediatric clinical studies of abacavir. This study is offered in Los Angeles (call 213-669-4537), New York City (call 718-245-4486), and in Denver, Tampa and Springfield, MA. (CNAA/B3007)
This study is intended for children who have rapidly progressing or advanced HIV disease despite taking continuous antiretroviral therapy for at least 8 weeks. This Phase I/II study aims to see if new drug combinations can reduce HIV viral load in these children, to see how long that reduction lasts and to evaluate the safety of different doses of these combinations. Based on which antiretroviral medications participants have already tried, children will receive 1 of 3 novel 4-drug antiretroviral regimens that include 2 protease inhibitors. The study lasts 1 year, but children may stay on their medications for an additional 48 weeks if they appear to be doing well. To enroll, children must be between 6 months and 21 years old and can have any CD4 count or viral load level. They must also have evidence of HIV disease progression or advanced disease and have taken at least 8 weeks of antiretroviral therapy. Children must be able to receive at least 2 drugs that they have never used before, and 1 of these drugs must be ritonavir (Norvir), nelfinavir or nevirapine (Viramune). Participants cannot have any cancers that require chemotherapy, prior pancreatitis, severe peripheral neuropathy, or have used ritonavir and nelfinavir in combination. This study is offered around the country; call 1-800-TRIALS-A for more information. (Pediatric ACTG 366)
Katy Stephenson is a research associate with the Community Consortium of the UCSF AIDS Program at SF General Hospital.
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