Clinical trial NCT00002239: A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV-1
Dose-Response Relationship, Drug
Drug Therapy, Combination
VX 478
Anti-HIV Agents
pentafuside
abacavir
efavirenz
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Trimeris
First posted: 2001-08-31
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pacific Oaks Research
state: California
city: Los Angeles
country: United States
facility: UCLA Care Ctr
state: California
city: Palm Springs
country: United States
facility: ViRx Inc
state: California
city: Palm Springs
country: United States
facility: Donald Northfelt
state: California
city: San Diego
country: United States
facility: UCSD
state: California
city: San Francisco
country: United States
facility: ViRx Inc
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Washington
country: United States
facility: Dupont Circle Physicians Group
state: District of Columbia
city: Altamonte Springs
country: United States
facility: IDC Research Initiative
state: Florida
city: Fort Lauderdale
country: United States
facility: Gary Richmond MD
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: St. Louis
country: United States
facility: Washington Univ School of Medicine
state: Missouri
city: New York
country: United States
facility: New York Univ Med Ctr
state: New York
city: Durham
country: United States
facility: Trimeris Inc
state: North Carolina
city: Tulsa
country: United States
facility: Associates of Med and Mental Health
state: Oklahoma
city: Philadelphia
country: United States
facility: Pennsylvania Oncology and Hematology Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Univ of Pittsburgh
state: Pennsylvania
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
Study officials:
References: