Three Doses of T-20 Combination Therapy in HIV-1 Infected Adults
Enfuvirtide
+ Ritonavir
+ Abacavir sulfate
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: May 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.68 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 20 locations
UCLA Care Ctr
Los Angeles, United StatesViRx Inc
Palm Springs, United StatesDonald Northfelt
Palm Springs, United States