DRUG
A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
Status
Completed
Phase
Phase 2
Enrollment
68
Locations
20
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
DRUG
Ritonavir
DRUG
Abacavir sulfate
DRUG
Amprenavir
DRUG
Efavirenz
Timeline
From registration to results.
First posted
Aug 31, 2001
Study start
May 1999
Primary completion
Not reported
Study completion
Not reported
Results posted
Not reported
Registry updated
Nov 15, 2005
Outcomes
What the study measures.
Primary outcomes
Not reported in the indexed record.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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.
Study locations
20 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Pacific Oaks Research
Beverly Hills, California, United States
UCLA Care Ctr
Los Angeles, California, United States
ViRx Inc
Palm Springs, California, United States
Donald Northfelt
Palm Springs, California, United States
UCSD
San Diego, California, United States
ViRx Inc
San Francisco, California, United States
Quest Clinical Research
San Francisco, California, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
IDC Research Initiative
Altamonte Springs, Florida, United States
Gary Richmond MD
Fort Lauderdale, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
Washington Univ School of Medicine
St Louis, Missouri, United States
New York Univ Med Ctr
New York, New York, United States
Trimeris Inc
Durham, North Carolina, United States
Associates of Med and Mental Health
Tulsa, Oklahoma, United States
Pennsylvania Oncology and Hematology Associates
Philadelphia, Pennsylvania, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States
Central Texas Clinical Research
Austin, Texas, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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