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 - Tabular View

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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
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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.