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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002216
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

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.

Interventions

DRUGLamivudine/Zidovudine
DRUGAbacavir sulfate
DRUGAmprenavir
DRUGNelfinavir mesylate

Sponsors

Glaxo Wellcome
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026