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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Amprenavir
Lamivudine
Zidovudine
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Sites / Locations

  • Pacific Oaks Research
  • Dr Bruce Rashbaum
  • Community Research Initiative of South Florida
  • Community Research Initiative of Central Florida
  • Univ of Miami School of Medicine
  • Chicago Ctr for Clinical Research
  • Community Research Initiative of New England
  • Saint Vincent's AIDS Ctr
  • Methodist Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
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1. Study Identification

Unique Protocol Identification Number
NCT00002195
Brief Title
A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
Official Title
A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection.
Study Type
Interventional

2. Study Status

Record Verification Date
November 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Glaxo Wellcome

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Enrollment
290 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amprenavir
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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.
Facility Information:
Facility Name
Pacific Oaks Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Dr Bruce Rashbaum
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Community Research Initiative of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Facility Name
Community Research Initiative of Central Florida
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Univ of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Chicago Ctr for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Community Research Initiative of New England
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
Saint Vincent's AIDS Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Methodist Hosp
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

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

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