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

A Controlled Phase 2 Trial Assessing Three Doses of T-20 in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz in HIV-1 Infected Adults

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Ritonavir; Drug: Enfuvirtide; Drug: Abacavir sulfate; Drug: Amprenavir; Drug: Efavirenz

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.

• Study Type: Interventional
• Enrollment: 68
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Trimeris

Study record dates

Study Major Dates

• Study Start: May 1, 1999
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): November 15, 2005
• Last Update Submitted That Met QC Criteria: November 14, 2005
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Keywords: Drug Therapy, Combination; Anti-HIV Agents; HIV-1; Dose-Response Relationship, Drug; VX 478; pentafuside; abacavir; efavirenz
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; HIV Protease Inhibitors; Viral Protease Inhibitors; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C9 Inhibitors; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Ritonavir; Enfuvirtide; Efavirenz; Abacavir; Amprenavir
• Other Study ID Numbers: T20-206; 295B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No