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A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients

This study has been completed.
Study NCT00002178.   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 Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
Official Title  A Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
Brief Summary

To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (< 400 copies/ml) at week 16 and 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA and in absolute CD4 cell count during the 24 weeks of study treatment. To collect safety data on the treatment regimens. To determine the percentage of patients without SQV soft gel capsules resistance-associated mutations at week 24.

Detailed Description

Patients are randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) soft gel capsules (sgc) plus 2 reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus RTI, and Group C - SQV sgc plus nelfinavir plus RTI (or SQV sgc plus ritonavir plus 2 RTIs).

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Ritonavir
Drug: Nelfinavir mesylate
Drug: Saquinavir
Drug: Delavirdine mesylate
MEDLINE PMIDs 11364377
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  375
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria

Patients must have:

  • HIV RNA >= 5000 copies/ml by Amplicor assay.
  • Signed, informed consent from parent or legal guardian for patients less than 18 years old.

Previous treatment with antiretrovirals.

Gender Both
Ages 16 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002178
Organization ID 229J
Secondary IDs †† NR15539
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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