HIV Infections
Conditions
Keywords
HIV-1, Dose-Response Relationship, Drug, Drug Therapy, Combination, VX 478, Anti-HIV Agents, pentafuside, abacavir, efavirenz
Brief summary
The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.
Detailed description
Patients are assigned to one of four groups. Three dose groups receive a background antiretroviral regimen (ABC, APV, RTV, and EFV) and T-20, which is given at one of three doses on a twice-daily regimen. The fourth group (control) receives the background antiretroviral regimen alone. For each treatment group, 17 patients are enrolled. Treatment is administered for 16 weeks, followed by a 32-week treatment extension, and a 2-week follow-up period. The following are assessed throughout the trial: safety parameters (as measured by hematology, clinical chemistry, urinalysis, and treatment-emergent adverse events); virologic and immunologic activity; phenotypic and genotypic resistance; T-20 plasma levels; and pharmacokinetics of T-20 and oral antiretrovirals. The total study duration is 1 year.
Interventions
Sponsors
Trimeris
Hoffmann-La Roche
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients may be eligible for this study if they: * Are HIV-positive. * Have an HIV level (viral load) between 400 and 100,000 copies/ml at the screening visit. * Have taken at least 1 PI (protease inhibitor) for at least 16 weeks, and have had no interruptions in their most recent PI-containing anti-HIV drug regimen. * Are at least 18 years old. * Agree to abstinence or use of 2 effective methods of birth control, including a barrier method, during the study.
Exclusion criteria
Patients will not be eligible for this study if they: * Have ever taken an NNRTI (nonnucleoside reverse transcriptase inhibitor). * Have an opportunistic (HIV-related) infection. * Have had an unexplained fever of at least 38.5 C for 7 days in a row within 30 days prior to screening. * Have had diarrhea lasting at least 15 days within 30 days prior to screening. * Have ever taken abacavir, amprenavir, or efavirenz (ABC, APV, or EFV). * Have certain genetic characteristics (drug resistance mutations) that could change the way a drug acts in the body. * Are allergic to any of the study medications. * Have a tumor other than certain skin or cervical cancers. * Are on chemotherapy that cannot be discontinued during the study. * Are taking an investigational drug within 30 days prior to screening. * Have ever received an HIV vaccine. * Are taking certain medications. * Abuse drugs or alcohol. * Have hemophilia or another blood clotting disorder. * Have had an organ transplant. * Are pregnant or breast-feeding.
Countries
United States
Outcome results
None listed