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NCT00002190 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002190
Other study ID # 229N
Secondary ID NV15114
Status Completed
Phase Phase 2
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date July 1997
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Saquinavir

• Lamivudine

• Zidovudine

Locations
Country Name City State
United States Columbia Presbyterian Med Ctr New York New York
United States Davies Med Ctr / c/o HIV Institute San Francisco California
United States Pacific Oaks Med Group / Rsch & Scientific Investigation Sherman Oaks California

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

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