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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.

Sponsors and Collaborators: Hoffmann-La Roche
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

MedlinePlus related topics:   AIDS    AIDS Medicines   

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

U.S. FDA Resources

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

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


Study ID Numbers:   T20-206, 295B
First Received:   November 2, 1999
Last Updated:   November 14, 2005
ClinicalTrials.gov Identifier:   NCT00002239
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

Study placed in the following topic categories:
Virus Diseases
Efavirenz
Amprenavir
Sexually Transmitted Diseases, Viral
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Abacavir
Retroviridae Infections
Enfuvirtide
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
HIV Protease Inhibitors
Slow Virus Diseases
Anti-HIV Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Antibiotics, Antitubercular
Protease Inhibitors
Anti-Bacterial Agents
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
HIV Fusion Inhibitors

ClinicalTrials.gov processed this record on December 03, 2008




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