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A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs

This study has been completed.
Study NCT00002367.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
Official Title  An Open-Label, Non-Comparative Study of Saquinavir-SGC in Combination With Zidovudine (AZT) and Lamivudine (3TC) in the Treatment of HIV-1 Infected Patients With No Previous Anti-Retroviral Drug Therapy
Brief Summary

To evaluate the efficacy of Saquinavir-SGC combination with Zidovudine and Lamivudine in the treatment of HIV-1 infected patients with no previous anti-retroviral drug therapy.

Detailed Description

All enrolled patients will receive the following 3 drug combination: Saquinavir, Zidovudine and Lamivudine. Efficacy and duration of anti-viral response will be evaluated by monitoring of HIV-1 RNA levels. Patients below the detectable limit of 200 copies/ml will be analyzed using the Ultra-direct method with a detection limit of 20 copies/ml. CD4 and CD8 cell counts will also be analyzed.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Parallel Assignment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Saquinavir
Drug: Lamivudine
Drug: Zidovudine
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  40
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria

Patients must have:

  • Plasma HIV-1 RNA titers > 10,000 copies/ml.
  • CD4 cell count > 100 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following conditions will be excluded:

  • Any prior anti-retroviral drug therapy.

Prior Medication:

Excluded:

Previous anti-retroviral drug therapy.

Gender Both
Ages 16 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002367
Organization ID 229F
Secondary IDs †† NR15503, M61005
Study Sponsor  Hoffmann-La Roche
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date August 1997
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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