Open Clinical Trials for HIV/AIDS Treatments
AIDSinfo, a new Web site of the U.S. Department of Health and Human Services (DHHS), allows users to search for HIV/AIDS-related studies in a database maintained by ClinicalTrials.gov, a clinical trial listing for all diseases. The database may be accessed at either www.aidsinfo.nih.gov or www.clinicaltrials.gov. AIDSinfo also offers a toll-free telephone help line at 800-448-0440 (TDD/TTY 888-480-3739; international callers should dial 301-519-0459). Specialists are on hand Monday through Friday from 12:00 pm to 5:00 pm ET (9:00 am to 2:00 pm PT) to help locate trials and answer questions.
The AIDS Community Research Initiative of America (ACRIA) maintains a directory of HIV/AIDS clinical trials in New York state, New Jersey, Connecticut, and Philadelphia, and may expand to other areas of the country in the future. The ACRIA directory is available at www.criany.org/acria.html.
Call the telephone numbers below for more information about specific trials and a listing of study sites. Protocol (study) numbers, if available, are provided in parentheses at the end of each trial description.
GlaxoSmithKline's new PI candidate; or lopinavir, ritonavir, and GW433908. All participants will also take one or two nucleoside reverse transcriptase inhibitors (NRTIs) and tenofovir DF (TDF, Viread); the NRTIs are not provided by the study. Blood will be drawn and tested for drug levels at weeks 12, 24, and 48. A substudy (A5174S) will conduct more intensive sampling of blood drug levels; the first 20-25 participants enrolled in each arm will also be enrolled in the substudy.
Participants must be at least 18 years of age, have been on antiretroviral therapy for a total of at least one year, and have a viral load above 500 copies/mL within 60 days of prestudy screening despite being on a stable (unchanged) anti-HIV regimen for at least 12 weeks. Exclusion criteria include previous use of both lopinavir and amprenavir (Agenerase) for more than seven days each; untreated serious illnesses; or use of other experimental drugs, cancer chemotherapy, or immune-modulating drugs within 30 days of study entry. Women must not be pregnant or breast-feeding.
There are over 30 study sites including Atlanta (404-616-6313), Boston (617-726-3819), Chapel Hill (919-843-8761), Chicago (312-942-5865), Cleveland (216-844-8051), Denver (303-372-5535), Los Angeles (323-343-8283), New York City (212-305-2665), San Francisco (415-514-0550 ext. 362), and Seattle (206-731-8877). (ACTG A5143/A5147S)
Participants must be at least 18 years of age and have a viral load between 500 and 100,000 copies/mL within 45 days of study entry. They must have taken an antiretroviral regimen that includes two NRTIs plus nelfinavir, saquinavir, or amprenavir for at least 12 weeks before study entry. There must be at least one NRTI that has not been taken for more than 14 days, or never taken at all in the case of 3TC (lamivudine, Epivir). Exclusion criteria include taking any PIs other than those listed above or having HIV that is resistant to indinavir or ritonavir. Subjects must not have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs), experimental drugs, or immune-modulating drugs within 30 days of study entry. Subjects also must not have had any active opportunistic illnesses (OIs), infections that require treatment, or fever within 14 days of study entry, or any cancers that require chemotherapy. Women may not be pregnant or breast-feeding. Finally, subjects must be willing and able to drink 1.5 liters of water or other fluids each day.
Study sites include Baltimore (410-955-4370), Birmingham (205-975-7925), Indianapolis (317-274-8456), New York City (212-420-4432), Philadelphia (215-349-8092), and San Francisco (415-476-9296 ext. 350). (ACTG A5055)
Participants must be at least 18 years of age and have used NRTIs, NNRTIs, and PIs. They must have been on continuous antiretroviral therapy for the 24 weeks before study entry, with no regimen changes in the preceding 12 weeks (except for substitutions within the same drug class due to toxicity). Participants must have experienced failure of at least one highly active antiretroviral therapy (HAART) regimen before study entry, and must have had a viral load greater than 500 copies/mL within the four months preceding the study. Those who experienced virological failure on their first HAART regimen are not eligible. Recent genotypic resistance testing must show at least two major mutations conferring resistance to NRTIs or PIs; participants must also show evidence of current or prior NNRTI resistance. Exclusion criteria include previous use of T-20 or T-1249; unstable HIV disease that increases risk of disease progression during the STI; an active, untreated OI or unexplained fever; active hepatitis C requiring treatment; cancer requiring chemotherapy; or other severe illness. Women must not be pregnant or breast-feeding.
This study is offered through the University of California at San Francisco (UCSF). For information contact Anna Smith, R.N., at 415-476-9296 ext. 330.
Participants must be at least 13 years of age and have been taking stable antiretroviral treatment for at least six months before study entry. They must have had a pretreatment CD4 cell count above 350 cells/mm3; in addition, they must have had a CD4 cell count above 350 cells/mm3 and a viral load below 55,000 copies/mL within 45 days of study entry.
Study sites include Dallas (214-590-0414), San Francisco (415-514-0550 ext. 354), and Stanford (650-723-2804). (ACTG A5170)
Participants must be at least 18 years of age, have been on continuous HAART for at least three months, and have experienced failure of at least two different multidrug regimens. Their two most recent test results while on therapy must have shown a CD4 cell count below 100 cells/mm3 and a viral load above 5,000 copies/mL, or a CD4 cell count below 200 cells/mm3 and a viral load above 10,000 copies/mL. Exclusion criteria include currently taking a regimen of five or more anti-HIV drugs, inability to tolerate multiple drugs, or current serious OIs. Women may not be pregnant or breast-feeding.
In the U.S., the study will be conducted at 30 Veterans Administration medical centers, including Baltimore (410-605-7199), Boston (617-232-9500 ext. 4669), Cleveland (216-791-3800 ext. 4788), Dallas (214-857-0410), Durham (919-286-0411 ext. 7308), Los Angeles (310-268-3015), Miami (305-324-4455 ext. 4800), New York City (212-951-3348), Palo Alto (650-493-5000 ext. 63408), Philadelphia (215-823-5847), Phoenix (602-277-5551 ext. 6796), Portland (503-220-8262 ext. 57140), and San Diego (858-552-8585 ext. 2626). (CTN 167)
Participants must be at least 18 years of age and have a viral load of 2,000 copies/mL or more at study screening and at least one viral load measurement of 400 copies/mL or more within 60 days of study entry. Subjects' failing HAART regimens must consist of at least three but fewer than six drugs; at least one failing regimen must have included a PI. Participants must have been taking their current regimen for at least 12 weeks before study entry. Exclusion criteria include having an acute illness requiring treatment within 21 days of study entry, cancer requiring radiation or chemotherapy, or a history of pancreas problems. Subjects should not have recently received experimental drugs, immune-modulating drugs, or HIV vaccines, and may not have used a previous mega-HAART regimen containing more than six drugs. Women must not be pregnant or breast-feeding.
Study sites include Boston (617-632-0785), Chicago (312-572-4545), Denver (303-372-5535), New York City (212-263-6565), Pittsburgh (412-647-0771), Rochester (585-275-2740), San Francisco (415-514-0550 ext. 362), and Seattle (206-731-8877). (ACTG A5146).
Participants must be at least 18 years of age and have been taking anti-HIV therapy (at least two NRTIs plus either an NNRTI or a PI) with an undetectable viral load for at least one month. They must have a CD4 cell count of at least 175 cells/mm3 within 30 days of study entry. Viral load must have been below 500 copies/mL for at least one month, and below 50 copies/mL at least once within 30 days of enrollment. Exclusion criteria include evidence of drug-resistant HIV, symptomatic OIs, hepatitis B, or serious conditions such as heart or kidney disease. Subjects may not be taking nevirapine (Viramune) or abacavir (Ziagen). Women must not be pregnant.
For more information and a list of study sites contact Diane Rock Kress, R.N., at 301-435-8003 or 800-772-5464 ext. 58003. (M77-02-I-0013)
Participants must be at least 13 years of age and have a CD4 cell count above 350 cells/mm3. Subjects may be using any available antiretroviral and immune-modulating drugs at study entry. Women must not be pregnant or breast-feeding.
There are 20 study sites, including Boston (617-778-5456), Chicago (773-244-5802), Denver (303-436-7195), Fort Lauderdale (954-467-3006 ext. 223), Los Angeles (310-478-3711 ext. 40272), Minneapolis (612-347-7678), New Orleans (504-584-1971), New York City (212-939-2917), San Francisco (415-476-9554 ext. 23), and Washington, DC (202-745-8301). (CPCRA 065)
Participants must be at least 18 years of age, have a viral load between 5,000 and 100,000 copies/mL within six weeks prior to prestudy screening, and have a CD4 cell count above 50 cells/mm3 within four weeks of enrollment or above 100 cells/mm3 within eight weeks of enrollment. They must have been on stable anti-HIV therapy containing d4T, ddI, or efavirenz for at least six months. Subjects must not have had an acute infection or received a vaccine within the previous four weeks. Certain anti-HIV and other drugs are excluded. Women may not be pregnant.
For more information and study sites, contact 800-772-5464 ext. 57689 or 800-411-1222. (01-I-0004)
Participants must be at least 18 years of age and have a CD4 cell count of at least 300 cells/mm3. They must currently be taking anti-HIV therapy or be willing to start treatment. Exclusion criteria include any AIDS-defining illness in the past year, or current cancer or major heart, lung, kidney, central nervous system, or immune system disorders. Participants must not have taken IL-2 in the past, or corticosteroids or other immune-suppressing drugs or cytotoxic (cell-killing) agents within 45 days of study entry. Women must not be pregnant or breast-feeding.
There are over 30 study sites, including Atlanta (404-321-6111 ext. 3298), Berkeley (415-476-9554 ext. 22), Bethesda (301-435-7689), Detroit (313-343-7351), Houston (713-500-6751), Los Angeles (310-478-3711 ext. 42745), Miami (305-323-3267), Newark (973-483-3444 ext. 33), and San Francisco (415-476-9554 ext. 22).
Several clinical measurements will be performed at study entry. Participants will be randomized to receive either metformin plus rosiglitazone placebo (arm A), rosiglitazone plus metformin placebo (arm B), metformin plus rosiglitazone (arm C), or placebos of both drugs (arm D). After 16 weeks participants who remain in the study will be switched to an open-label phase and all will receive metformin plus rosiglitazone for an additional 16 weeks. Clinic visits will take place at weeks 2, 4, 8, 12, 16, 18, 20, 24, 28, and 32. Insulin and glucose levels will be assessed; blood must be drawn after fasting overnight. In addition, visceral (internal) fat, subcutaneous fat, and thigh size will be measured.
Participants must be between 18 and 65 years of age and have a viral load below 10,000 copies/mL within 30 days of study entry. They must have specific blood insulin levels and meet physical restrictions based on height, weight, and amount and location of body fat. Subjects must have been taking a stable anti-HIV regimen for at least 60 days before study entry. Exclusion criteria include diarrhea, nausea, vomiting, or heart disease; previous use of drugs to control blood sugar; and use of immune-modulating drugs within six months of study entry. Participants may not be taking ritonavir with either simvastatin (Zocor) or lovastatin (Mevacor); there are also restrictions regarding use of hormones. Women must not be pregnant or breast-feeding.
Study sites include Birmingham (205-975-7925), Boston (617-726-3819), Chicago (312-695-5012), Cincinnati (513-584-8373), Honolulu (808-737-2751), Los Angeles (310-206-8029), New York City (212-420-4432), San Francisco (415-514-0550 ext. 362), and Washington, DC (202-687-5378). (ACTG A5082)
Participants must be at least 13 years of age and intend to start antiretroviral treatment within 14 days of study entry, either as part of another clinical trial or under the care of their own physician. Exclusion criteria include previous use of antiretroviral therapy for more than 14 days, or use of certain immune-modulating, anti-HPV, or experimental drugs. Subjects may not have a history of cervical cancer and may not have participated in previous HPV trials.
Study sites include Baltimore (410-614-4487), Birmingham (205-975-7925), Boston (617-632-0785), Los Angeles (323-343-8283), Miami (305-243-2154), New York City (212-420-4432), San Francisco (415-514-0550 ext. 362), and San Juan (787-759-9595). (ACTG A5029)
Participants must be at least 18 years of age, have HIV-related painful neuropathy, have been taking stable anti-HIV therapy for the past eight weeks, and have used marijuana at least six times in the past. There are no CD4 cell count or viral load requirements. Exclusion criteria include use of smoked marijuana within 30 days of study entry; current tobacco smoking; active substance abuse; history of heart, lung, kidney, or liver disease; and active OIs requiring treatment. Women must not be pregnant or breast-feeding.
The study will take place in San Francisco (415-476-9554 ext. 21). (00018269)
Liz Highleyman (email@example.com) is a freelance medical writer and editor based in San Francisco.
This article was provided by San Francisco AIDS Foundation. It is a part of the publication Bulletin of Experimental Treatments for AIDS. Visit San Francisco AIDS Foundation's Web site to find out more about their activities, publications and services.