Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.

Phase 2

Completed

• Conditions: HIV; HIV-1; Human Immunodeficiency Virus

• Registration Number: NCT00298350
• Lead Sponsor: Gilead Sciences

Brief Summary

The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137 relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of combination antiretroviral regimens in subjects who have failed, or are failing, protease inhibitor therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-28
• Study First Submitted QC: 2006-02-28
• Study First Posted: 2006-03-02
• Primary Completion: 2007-06
• Study Completion: 2007-07
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-28
• Last Update Posted: 2008-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

• HIV RNA greater than or equal to 1000 c/mL.
• Failed/Failing protease inhibitor based antiretroviral therapy.
• Stable antiretroviral therapy for greater than or equal to 30 days prior to screening.
• Negative Serum Pregnancy Test.
• GFR by Cockcroft Gault greater than or equal to 80 mL/min.
• AST & ALT less than or equal to 2.5x ULN.
• Total Bilirubin less than or equal to 1.5 mg/dL.
• Albumin greater than 3.5 mg/dL.
• Prothrombin Time INR 1.0-1.4
• Platelets greater than or equal to 50,000.
• Hemoglobin greater than or equal to 8.0 mg/dL.
• Absolute Neutrophil Count greater than or equal to 1000.

Exclusion Criteria

• New AIDS defining condition within 30 days of baseline.
• Prior treatment with HIV-1 integrase inhibitor (except patients from 183-101).
• Ascites or encephalopathy.
• Breast Feeding.
• Cancer Diagnosis (besides Kaposi Sarcoma or Basal Cell Carcinoma).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL