CClinicalTrials.gg
CompletedNCT00002195Updated Jun 24, 2005

A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients

A Phase 3 interventional study of Amprenavir and Lamivudine in HIV Infections, sponsored by Glaxo Wellcome. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Glaxo Wellcome · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
290
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.

Read the detailed description

This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir.

02

Conditions studied

  • HIV Infections

Keywords

  • Drug Therapy, Combination
  • Zidovudine
  • HIV Protease Inhibitors
  • Lamivudine
  • VX 478
  • Reverse Transcriptase Inhibitors
  • Anti-HIV Agents
  • Viral Load
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 290 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Glaxo Wellcome is the lead sponsor of 72 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patients must have:

  • HIV-positive status.
  • Screening viral load >= 10,000 copies/mm3 14 days prior to entry.
  • CD4+ cell counts >= 200 cells/mm3 14 days prior to entry.

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Clinical diagnosis of AIDS (CDC 1993 Classification C).

Concurrent Medication:

Excluded:

Terfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.

Patients with the following prior conditions are excluded:

Clinically relevant hepatitis in the previous 6 months.

Prior Medication:

Excluded:

  • Greater than 4 weeks of any nucleoside antiretroviral therapy.
  • Previous therapy with an HIV protease inhibitor.
  • Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.
  • Immunomodulating agents within 3 months prior to entry.

Prior Treatment:

Excluded:

Radiotherapy within 4 weeks prior to entry.

Risk Behavior:

Excluded:

Current alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Intervention model
Parallel assignment
Enrollment
290 participants

Interventions

  • DrugAmprenavir
  • DrugLamivudine
  • DrugZidovudine
06

Study locations

9 sites
  • Pacific Oaks Research
    Beverly Hills, California 90211, United States
  • Dr Bruce Rashbaum
    Washington, District of Columbia 20037, United States
  • Community Research Initiative of South Florida
    Coral Gables, Florida 33146, United States
  • Community Research Initiative of Central Florida
    Maitland, Florida 32751, United States
  • Univ of Miami School of Medicine
    Miami, Florida 33136, United States
  • Chicago Ctr for Clinical Research
    Chicago, Illinois 60610, United States
  • Community Research Initiative of New England
    Brookline, Massachusetts 02445, United States
  • Saint Vincent's AIDS Ctr
    New York, New York 10011, United States
  • Methodist Hosp
    Memphis, Tennessee 38104, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00002195
Lead sponsor
Glaxo Wellcome
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 1998. You cannot join it, but the record below documents what was studied.

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