A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002374
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002374 on ClinicalTrials.gov Archive Site
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A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients
A Phase IIIB Open-Label Trial Replacing Saquinavir HGC (Ro 31-8959) With Saquinavir SGC (Ro 31-8959) in Combination With Other Antiretroviral Drugs in Patients With HIV-1 Infection

To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.

Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) >= 5,000-30,000 HIV-1 RNA, 2) > 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors [RTIs]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24.

Interventional
Phase 3
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Ritonavir
  • Drug: Nelfinavir mesylate
  • Drug: Saquinavir
  • Drug: Stavudine
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Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
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Inclusion Criteria

Patients must have:

  • Documented HIV infection.
  • CD4 > 100 cells/mm3.
  • Saquinavir HGC-experienced patients (>= 3 months cumulative therapy).

Required:

>= 3 months cumulative saquinavir HGC therapy.

Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002374
229G, NR15521
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Hoffmann-La Roche
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NIH AIDS Clinical Trials Information Service
August 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP