A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients

To explore the antiviral efficacy, tolerability and safety of saquinavir plus zidovudine plus lamivudine.

Completed

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Davies Med Ctr / c/o HIV Institute, San Francisco, California, United States

About this study

A total of 30 patients receive the triple drug regimen saquinavir plus zidovudine plus lamivudine until the completion of the analysis after at least 4 weeks of therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must have:

HIV antibody positive.
CD4 count >= 150 and <= 500 cells/mm3.

Exclusion criteria

Prior Medication:

Excluded:

Prior antiretroviral therapy.
Prior protease inhibitor therapy.

Treatment and study plan

Saquinavir

Drug

Lamivudine

Drug

Zidovudine

Drug

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

First posted: Aug 31, 2001
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed