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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

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ClinicalTrials.gov Identifier: NCT00002239
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : November 15, 2005
Information provided by:
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Enfuvirtide Drug: Ritonavir Drug: Abacavir sulfate Drug: Amprenavir Drug: Efavirenz Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 68 participants
Primary Purpose: Treatment
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 Start Date : May 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002239

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Sponsors and Collaborators
Hoffmann-La Roche
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ClinicalTrials.gov Identifier: NCT00002239    
Other Study ID Numbers: T20-206
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: November 15, 2005
Last Verified: November 2005
Keywords provided by Hoffmann-La Roche:
Dose-Response Relationship, Drug
Drug Therapy, Combination
VX 478
Anti-HIV Agents
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors