A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lamivudine/Zidovudine

Abacavir sulfate

Amprenavir

Nelfinavir mesylate

About this trial

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

Eligibility Criteria

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

Inclusion Criteria Patients must have: CD4 count > 50. HIV RNA > 5,000. No active AIDS (excluding CD4 count < 200). Ability to comply with dosing schedule and protocol evaluations. Prior Medication: Allowed: 3TC or any protease inhibitor, if < 1 week of therapy. Other nucleoside analogs, if < 4 weeks of therapy. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Active AIDS (not including CD4 count < 200). Malabsorption syndrome affecting drug absorption. Concurrent Medication: Excluded: Enrollment in any other investigational drug protocol. Prior Medication: Excluded: Non-nucleoside reverse transcriptase inhibitors.

Sites / Locations

Anderson Clinical Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002216

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Glaxo Wellcome

1. Study Identification

Unique Protocol Identification Number

NCT00002216

Brief Title

A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment

Official Title

A Comparison of a Four-Drug Regimen Comprised of 141W94, 1592U89, and Combivir With a Three-Drug Regimen Comprised of Nelfinavir and Combivir in Antiretroviral-Naive HIV-Infected Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

May 1999

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 compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment.

Detailed Description

In this open-label study antiretroviral-naive patients are randomized to one of two drug regimens: Arm I: 141W94 (amprenavir), 1592U89 (abacavir), and Combivir (3TC/AZT tablet). Arm II: Nelfinavir and Combivir.

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, HIV Protease Inhibitors, VX 478, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Masking

None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Lamivudine/Zidovudine

Intervention Type

Drug

Intervention Name(s)

Abacavir sulfate

Intervention Type

Drug

Intervention Name(s)

Amprenavir

Intervention Type

Drug

Intervention Name(s)

Nelfinavir mesylate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria Patients must have: CD4 count > 50. HIV RNA > 5,000. No active AIDS (excluding CD4 count < 200). Ability to comply with dosing schedule and protocol evaluations. Prior Medication: Allowed: 3TC or any protease inhibitor, if < 1 week of therapy. Other nucleoside analogs, if < 4 weeks of therapy. Exclusion Criteria Co-existing Condition: Patients with any of the following symptoms or conditions are excluded: Active AIDS (not including CD4 count < 200). Malabsorption syndrome affecting drug absorption. Concurrent Medication: Excluded: Enrollment in any other investigational drug protocol. Prior Medication: Excluded: Non-nucleoside reverse transcriptase inhibitors.

Facility Information:

Facility Name

Anderson Clinical Research

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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