A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Enfuvirtide (Drug); Ritonavir (Drug); Abacavir sulfate (Drug); Amprenavir (Drug); Efavirenz (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Hoffmann-La Roche
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.
Clinical Details
Official title: A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-1 Infected Adults
Study design: Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pacific Oaks Research, Beverly Hills, California 90211, United States
UCLA Care Ctr, Los Angeles, California 90095, United States
Donald Northfelt, Palm Springs, California 92270, United States
ViRx Inc, Palm Springs, California 92262, United States
UCSD, San Diego, California 92103, United States
Quest Clinical Research, San Francisco, California 94115, United States
ViRx Inc, San Francisco, California 94109, United States
Dupont Circle Physicians Group, Washington, District of Columbia 200091104, United States
IDC Research Initiative, Altamonte Springs, Florida 32701, United States
Gary Richmond MD, Fort Lauderdale, Florida 33316, United States
AIDS Research Consortium of Atlanta, Atlanta, Georgia 30308, United States
Johns Hopkins Hosp, Baltimore, Maryland 21287, United States
Washington Univ School of Medicine, St. Louis, Missouri 63110, United States
New York Univ Med Ctr, New York, New York 10016, United States
Trimeris Inc, Durham, North Carolina 27707, United States
Associates of Med and Mental Health, Tulsa, Oklahoma 74114, United States
Pennsylvania Oncology and Hematology Associates, Philadelphia, Pennsylvania 19106, United States
Philadelphia FIGHT, Philadelphia, Pennsylvania 19107, United States
Univ of Pittsburgh, Pittsburgh, Pennsylvania 15261, United States
Central Texas Clinical Research, Austin, Texas 78705, United States
Additional Information
Starting date: May 1999
Last updated: November 14, 2005
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