Status:
COMPLETED
Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
Lead Sponsor:
Gilead Sciences
Conditions:
HIV
HIV-1
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00298350
Start Date
February 1 2006
End Date
July 1 2007
Last Update
July 29 2008
Active Locations (54)
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1
Phoenix, Arizona, United States, 85006
2
Little Rock, Arkansas, United States, 72207
3
Beverly Hills, California, United States, 90211
4
Fountain Valley, California, United States, 92708