A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults

This study has been completed.

First Received: November 2, 1999 Last Updated: November 14, 2005 History of Changes

Sponsor:	Hoffmann-La Roche
Collaborator:	Trimeris
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00002239

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Enfuvirtide Drug: Ritonavir Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz	Phase II

Study Type:	Interventional
Study Design:	Treatment, Pharmacokinetics Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS AIDS Medicines

Drug Information available for: Abacavir Efavirenz Ritonavir Enfuvirtide VX 478 Abacavir sulfate

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Estimated Enrollment:	68
Study Start Date:	May 1999

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002239

Locations

United States, California
UCSD
San Diego, California, United States, 92103
ViRx Inc
San Francisco, California, United States, 94109
Pacific Oaks Research
Beverly Hills, California, United States, 90211
UCLA Care Ctr
Los Angeles, California, United States, 90095
Quest Clinical Research
San Francisco, California, United States, 94115
ViRx Inc
Palm Springs, California, United States, 92262
Donald Northfelt
Palm Springs, California, United States, 92270
United States, District of Columbia
Dupont Circle Physicians Group
Washington, District of Columbia, United States, 200091104
United States, Florida
Gary Richmond MD
Fort Lauderdale, Florida, United States, 33316
IDC Research Initiative
Altamonte Springs, Florida, United States, 32701
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
United States, Missouri
Washington Univ School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
New York Univ Med Ctr
New York, New York, United States, 10016
United States, North Carolina
Trimeris Inc
Durham, North Carolina, United States, 27707
United States, Oklahoma
Associates of Med and Mental Health
Tulsa, Oklahoma, United States, 74114
United States, Pennsylvania
Univ of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States, 19107
Pennsylvania Oncology and Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705

Sponsors and Collaborators

Hoffmann-La Roche

Trimeris

More Information

No publications provided

Study ID Numbers:	T20-206, 295B
Study First Received:	November 2, 1999
Last Updated:	November 14, 2005
ClinicalTrials.gov Identifier:	NCT00002239 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:

HIV-1
Dose-Response Relationship, Drug
Drug Therapy, Combination
VX 478

Anti-HIV Agents
pentafuside
abacavir
efavirenz

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Anti-Bacterial Agents
Amprenavir
Anti-Retroviral Agents
Therapeutic Uses
Abacavir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Efavirenz
RNA Virus Infections

HIV Protease Inhibitors
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Enfuvirtide
Pharmacologic Actions
Antibiotics, Antitubercular
Protease Inhibitors
Virus Diseases
Ritonavir
HIV Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on November 30, 2009