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NCT00002239·Phase 2·INTERVENTIONAL

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

Enfuvirtide

DRUG

Ritonavir

DRUG

Abacavir sulfate

DRUG

Amprenavir

DRUG

Efavirenz

Timeline

From registration to results.

  1. First posted

    Aug 31, 2001

  2. Study start

    May 1999

  3. Primary completion

    Not reported

  4. Study completion

    Not reported

  5. Results posted

    Not reported

  6. 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.

Primary links

Continue at the source.

Related trials

More studies on Enfuvirtide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.