A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-1 Infected Adults

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Enfuvirtide
* Drug: Ritonavir
* Drug: Abacavir sulfate
* Drug: Amprenavir
* Drug: Efavirenz


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enfuvirtide|nan|
|Drug: Ritonavir|nan|
|Drug: Abacavir sulfate|nan|
|Drug: Amprenavir|nan|
|Drug: Efavirenz|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1, abacavir, Dose-Response Relationship, Drug, Drug Therapy, Combination, VX 478, Anti-HIV Agents, pentafuside, efavirenz