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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: HIV Integrase Inhibitors; HIV Protease Inhibitors; Integrase Inhibitors; Protease Inhibitors; Ritonavir

Criteria

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).