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CompletedNCT00002216Updated Jun 24, 2005

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

An interventional study of Lamivudine/Zidovudine and Abacavir sulfate in HIV Infections, sponsored by Glaxo Wellcome. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Glaxo Wellcome · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare 2 combination drug therapies in HIV-infected patients who have never received anti-HIV treatment.

Read the 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • Drug Therapy, Combination
  • HIV Protease Inhibitors
  • VX 478
  • Reverse Transcriptase Inhibitors
  • Anti-HIV Agents
  • abacavir
03

In context

HIV Infections

4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

Browse HIV 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:

  • 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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • DrugLamivudine/Zidovudine
  • DrugAbacavir sulfate
  • DrugAmprenavir
  • DrugNelfinavir mesylate
06

Study locations

1 site
  • Anderson Clinical Research
    Pittsburgh, Pennsylvania 15213, 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
NCT00002216
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 May 1999. You cannot join it, but the record below documents what was studied.

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