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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00002178
• Collaborator: (none)
• Enrollment: 375
• Locations: 2
• Patients Per Site: 187.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Ritonavir; Drug: Nelfinavir mesylate; Drug: Saquinavir; Drug: Delavirdine mesylate	Phase 3

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 Design

• Study Type: Interventional
• Primary Purpose: Treatment
• 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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 0 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr Charles Farthing	Los Angeles	California	United States	90048
2	Community Research Initiative	Brookline	Massachusetts	United States	02445

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8.

• ClinicalTrials.gov Identifier: NCT00002178
• Other Study ID Numbers: 229J; NR15539
• First Posted: Aug 31, 2001
• Last Update Posted: Jun 24, 2005
• Last Verified: Aug 1, 1997

• Keywords provided by , ,: HIV-1; Drug Therapy, Combination; HIV Protease Inhibitors; RNA, Viral; Dosage Forms; Saquinavir; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Viral Load
• Additional relevant MeSH terms: HIV Infections; Ritonavir; Nelfinavir; Saquinavir; Delavirdine

Study Results

No Results Posted as of Jun 24, 2005