Bulletin of Experimental Treatments for AIDS, October, 1998
All listings are taken from Trials Search, an on-line database of open clinical trials for HIV positive individuals. Trials Search is the most comprehensive source for clinical trial information, and is available at hivinsite.ucsf.edu/tsearch. The Community Consortium of the University of California at San Francisco (UCSF) AIDS Program at San Francisco General Hospital provides this free service. If you need further information about individual listings, call the number provided or consult Trials Search. Individuals who do not have access to the Internet can obtain information on all government-funded trials by calling the AIDS Clinical Trials Information Service (ACTIS) toll-free at 800-TRIALS-A (800-874-2572). Study numbers are included in parentheses at the end of each listing.
The purpose of this study is to compare the utility of FTC, a new nucleoside analog, with 3TC for the reduction of viral load. The study is aimed at participants who are already taking 3TC along with another nucleoside analog and a protease inhibitor. Participants will be randomly assigned to switch from 3TC to FTC, or to remain on 3TC. There will be study visits every two weeks for the first month, and then once a month for the next 48 weeks. Participants can have any CD4 count, but must have an undetectable viral load and be on antiretroviral therapy that includes 3TC, a protease inhibitor, and another nucleoside analog. Participants may not have severe chronic diarrhea, current opportunistic infections, or have ever used a non-nucleoside reverse transcriptase inhibitor (NNRTI) such as nevirapine. Participants will be paid for this study. It is offered in San Francisco (call 415-353-5623), Boston (call 617-726-3819), and Atlanta (call 404-876-2317 ext. 331). (303)
The purpose of this study is to determine which combination of MKC-442, a new NNRTI, and nelfinavir (Viracept), a protease inhibitor, is the most effective for reducing viral load to undetectable levels in six months. The study is aimed at participants who have never taken any protease inhibitors or NNRTIs before. Enrollees will be assigned by chance to receive either MKC-442 or a placebo, plus one of two doses of nelfinavir. At the beginning of the study, participants will also switch to one or two new nucleoside analogs, such as 3TC or ddI, and will not be able to take AZT while taking MKC-442. Study visits are once a month for six months, and then twice a month until week 48, when the study ends. Participants can have any CD4 count, but must have a viral load of at least 10,000 copies/mL and have had at least 16 weeks of prior experience taking at least two, but not all, nucleoside analogs. Participants may not have any active AIDS-defining conditions, pancreatitis, severe peripheral neuropathy, chronic diarrhea, or recent radiation, chemotherapy, or use of immunomodulators. This study is offered in Los Angeles (call 213-980-4466 ext. 245), Irvine, CA (call 949-753-0670), New York (call 212-523-6743), and many other sites around the country. (MKC-303)
The purpose of this study is to see which triple combination therapy is most effective for long-term suppression of HIV viral load. Participants will be randomly assigned to receive either nelfinavir plus ddI and d4T, or nelfinavir plus AZT and 3TC. Study visits are about once every two months, and participants will know which drugs they are taking. Enrollees must have at least 100 CD4 cells/mm3 and a viral load of at least 2,000 copies/mL. Participants may not have had more than four weeks of nucleoside analog (e.g., ddI, AZT) therapy or more than one week of protease inhibitor therapy, and may not have any active opportunistic infections, severe peripheral neuropathy, pancreatitis, or chronic hepatitis. This study lasts about 48 weeks. It is offered in Los Angeles (call 310-206-6414), New York (call 212-523-6743), Newark, NJ (call 973-483-3444 ext. 22), Chicago (call 312-942-5865), and many other sites. (A1454-148)
This Phase II study will evaluate whether T-20, a fusion inhibitor, is safe and effective for reducing HIV viral load. Enrollees will be randomly assigned to receive one of two doses of T-20 by injection under the skin, or one of four doses of T-20 by continuous infusion through a small plastic tube that is placed under the skin and changed every day. Participants must remain at the clinic all day on three occasions and receive multiple blood draws. Enrollees can have any CD4 count, but must have a viral load of at least 5,000 copies/mL and have been on stable antiretroviral therapy for six weeks. Participants may not have used any protease inhibitor besides indinavir, used any NNRTIs, or have had any active opportunistic infections, recent high fever, chronic diarrhea, or certain cancers. The study lasts seven weeks and participants will be paid. It is offered in Florida (call 407-647-3960).
This Phase II study aims to see if PMPA, a nucleotide analog reverse transcriptase inhibitor, is safe and effective for reducing HIV viral load in participants taking other antiretroviral medications. Participants will be randomly assigned to receive either a placebo or one of three doses of PMPA, which comes in pill form. They may change any antiretroviral medications after four weeks of taking PMPA; after 24 weeks, any participants taking a placebo will be offered genuine PMPA. Enrollees can have any CD4 count, but must have a viral load between 400 and 50,000 copies/mL and be on stable antiretroviral therapy. Participants may not have chronic diarrhea, or certain infections or cancers. The study lasts about one year. It is offered in Tampa, FL (call 888-968-CARES). (GS-98-902)
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. Enrollees 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 regimen, which must include either indinavir (Crixivan) or nelfinavir. Enrollees must have a stable viral load and can have any CD4 cell count. They must have experience using marijuana, but cannot have smoked marijuana or tobacco during the month before joining the study. Participants may not have any opportunistic infections or cancers, and cannot be taking certain other medications; women may not be pregnant. Participants will be paid $1,000 for completing the study. The trial is offered only in San Francisco. Call 415-502-5705. (CC038/GCRC531)
Interleukin 2
The purpose of this study is to see which dose of interleukin 2 (IL-2 or Proleukin), an immunomodulator, is most effective for raising CD4 cell counts and lowering HIV viral load. Enrollees will be randomly assigned to receive one of two doses of IL-2, which is given by injection under the skin, or no IL-2. If assigned to IL-2 treatment, participants will receive an injection for five consecutive days every eight weeks for at least 24 weeks, and possibly longer, depending on CD4 count. Enrollees can have any viral load level, but must have at least 350 CD4 cells/mm3 and be on antiretroviral therapy at the time of enrollment and throughout the study. Participants may not have ever used IL-2 before, have any cancers requiring chemotherapy, or have recently taken any steroids, immunomodulators, chemotherapy, or hydroxyurea. The study lasts at least one year and may continue as an international Phase III study in the future. This study is offered at sites around the country; call 1-800-TRIALS-A for more information. (CPCRA 059)
This study will observe the effect of genetically altered T-cells on HIV viral load in the body, including in lymph tissues. The study is aimed at participants who have undetectable viral load and are on stable highly active antiretroviral therapy (HAART). All participants in this study will undergo a process called lymphapheresis, meaning that they will give blood samples from which T-cells will be removed and expanded in the laboratory. By random assignment, these expanded T-cells will either be given back to the donor unaltered as an infusion, or the cells will be modified with two naturally occurring genes, CD4 and zeta, before being returned as an infusion. Infusions are given three times, two weeks apart, and participants will also be required to have five rectal biopsies to study the treatment's activity in lymph nodes. Enrollees must have at least 200 CD4 cells/mm3 and an undetectable viral load, and must have been on stable HAART for at least 24 weeks before enrolling. Participants may not have certain AIDS-defining infections, have received any prior gene therapy, or have recently used interferons, corticosteroids, anticoagulants, or interleukins. Participants will receive $925 for completing this study, which lasts nine months. The trial is offered in the San Francisco Bay Area (call 415-476-9296 ext. 316, 415-353-5623 or 650-364-6563) and in Boston (call 617-724-9189). (A-9801)
The purpose of this study is to see if genetically altered blood cells are safe and effective for reducing HIV viral load in participants at different stages of HIV infection. Enrollees will first receive injections of G-CSF, a drug that stimulates stem cells, and then will undergo apheresis, a process by which blood is removed from one arm, stem cells are separated out, and the blood is returned through the other arm. All participants will have the removed stem cells genetically altered with the RevM10 gene and given back as an infusion. Half of the participants will also receive infusions of cyclophosphamide (Cytoxan), a drug believed to facilitate the processing of altered stem cells in the body. Enrollees may have any CD4 count or viral load level, but must be on stable antiretroviral therapy. Participants may not have any cancers, have recently used G-CSF, GM-CSF, interleukins, interferons, growth hormones, steroids, or any investigational drug, or have recently undergone a pheresis procedure or treatment for an opportunistic infection. Participants will be paid for this study. The trial is offered in the San Francisco Bay Area (call 650-364-6563). (104)
This study aims to see if Remune (HIV-1 immunogen, or the Salk vaccine) has any effect on the immune system, as measured by CD4 counts, HIV viral load, and skin tests. Enrollees will be randomly assigned to receive either Remune or a placebo, and will not know which they are receiving throughout the study. Both Remune and the placebo are given as an injection into a muscle once every three months for one year, with study visits every couple of months. Enrollees must have an undetectable viral load, must have been taking antiretroviral therapy for at least six months prior to enrollment, and must have had more than 300 CD4 cells/mm3 before starting antiretroviral therapy. Participants may not have recently used any immunomodulators or been immunized, or have previously received Remune in a study. This study is offered in Boston only (call 617-726-3819). There is also an expanded access program for Remune available to participants with limited treatment options. This program is offered in Irvine, CA (call 949-753-0670), Fort Lauderdale, FL (call 954-565-4030) and Wichita, KS (call 316-261-2655). (IRC 822 and Expanded Access IRC 903)
The purpose of this Phase I study is to determine if it is safe to give genetically altered T-cells to individuals undergoing high-dose chemotherapy for lymphoma. Enrollees will first take lymphoma chemotherapy with G-CSF, a drug that stimulates stem cells. Then they will undergo an apheresis procedure in which blood is removed and stem cells (CD34 cells) are separated out. These cells will then be modified with either the anti-HIV ribozyme gene or with a neutral gene, and returned through infusion. Study visits are every three months for the first year, and then every six months for the second year. Enrollees must have at least 100 CD4 cells/mm3 at the time of lymphoma diagnosis and less than 10,000 HIV RNA copies/mL. They must also be on at least two antiretroviral drugs (but not AZT) and have biopsy-proven non-Hodgkin's lymphoma that is in complete or partial remission with chemotherapy. Participants may not have certain other cancers, evidence of active central nervous system lymphoma, certain opportunistic infections, or hepatitis B or C. This study is offered in Los Angeles (call 213-764-0371). (17NHLK-97-2)
The purpose of this study is to see if HAART has any impact on the livers of individuals with hepatitis C infection. The study is aimed at participants who are already enrolled in another ACTG-sponsored study that uses HAART. Enrollees will not receive any additional treatment, but will undergo blood tests about eight times over 48 weeks. Participants must have a viral load of at least 2,500 copies/mL and have tested positive for hepatitis C infection. Participants may not have had more than two weeks of experience with protease inhibitors, or any prior use of hydroxyurea, efavirenz (Sustiva), abacavir (Ziagen), or recent use of immunomodulators. People with liver disease, active hepatitis B infection, or any cancers requiring systemic chemotherapy are also excluded. This study is offered at sites around the country; call 1-800-TRIALS-A for more information. (ACTG 383)
The purpose of this study is to see if BMS-207147 is safe and effective for the treatment of thrush (oropharyngeal candidiasis). Enrollees will be randomly assigned to receive one of three doses of BMS-207147 to be taken for five days. On day 1 and day 5, participants will have to stay at the clinic for 24 hours for multiple blood draws; they will have three more study visits after day 5. Enrollees may have any viral load, but must have a CD4 count of at least 50 cells/mm3 and have uncomplicated thrush. Participants may not have oral ulcers, esophageal candidiasis, or be using any antifungal medicines or investigational drugs. This study lasts 33 days. It is offered in San Francisco (call 415-476-9296 ext. 305) and in Texas and Kansas. (A1422-005)
This Phase I study aims to see how 1263W94, an antiviral medication, is processed by the body, and to see if the drug is effective in reducing cytomegalovirus (CMV) viral load. Only men are allowed in this study. Enrollees will be randomly assigned to receive one of two doses of 1263W94, and on one occasion will have to stay in the clinic for 24 hours to receive multiple blood draws and a ganciclovir implant, and to have an eye tissue sample taken. Enrollees can have any CD4 count or viral load, but must require ganciclovir implants for the treatment of CMV retinitis. Participants may not have active hepatitis or cirrhosis, or have recently used cidofovir, intravenous (IV) or oral ganciclovir, IV foscarnet, or IV acyclovir. They also may not have had prior intraocular surgery besides the ganciclovir implant, cataract surgery, detached retina, or any other disease of the eye. This study lasts about eight days. It is located in Irvine, CA (call 949-824-8303). (CMAA1004)
This study aims to see if pancrelipase (Ultrase MT-20) is safe and effective for the treatment of diarrhea caused by nelfinavir, and to see if pancrelipase interferes with the way nelfinavir is processed by the body. Enrollees will receive pancrelipase for 12 weeks, and if enrolled in a substudy of nelfinavir processing, will also have two separate days of multiple blood draws. Participants will be allowed to take other antidiarrheal medicines throughout the study. Enrollees can have any CD4 count or viral load level, but must be taking nelfinavir 1,250 mg twice a day, have three or more loose stools per day, and have a negative stool culture for gastrointestinal pathogens and parasites. Participants may not have active gastrointestinal disease, past pancreatitis, or allergies to pork. This study lasts 12 weeks. It is offered in Boston (call 617-566-4004 ext. 13).
The purpose of this study is to see if the combination of indinavir, 3TC, and d4T is safe and effective for the reduction of HIV viral load in children. All children in this study will receive indinavir, 3TC, and d4T; there are no placebos. Children will have study visits about once a month for five months, and then once every two months for the rest of the study, which lasts 48 weeks. Participants can have any CD4 count or viral load level and must be 3-15 years old. Participants may not have ever used protease inhibitors or the 3TC/d4T combination, or have any opportunistic infections, hepatitis, or pancreatitis. This study is offered around the country; call 1-800-TRIALS-A for more information. (Pediatric ACTG 395)
The purpose of this study is to see if MKC-422, a new NNRTI, is safe and effective for reducing viral load in children when taken in combination with two nucleoside analogs, such as 3TC or AZT. All participants will receive MKC-422 in addition to two nucleoside analogs. Study visits are once a week for the first month, and then once a month for the remaining 48 weeks. Children will be required to stay at the clinic for multiple blood draws on a few occasions during the first month of the study. Participants may have any CD4 count or viral load level, must be 3-12 years of age, and cannot have ever used any NNRTIs. This study is offered in Florida (call 904-549-3051).
Katy Stephenson is a research associate with the Community Consortium of the UCSF AIDS Program at SF General Hospital.
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