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

Completed · Phase 2

Conditions studied: HIV, HIV-1, Human Immunodeficiency Virus

In brief

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.

Key facts

Study ID

NCT00298350

Run by

Gilead Sciences

People needed

278

Starts

2006-02-01

Expected to finish

2007-07-01

Last updated by the study team

2008-07-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Beverly Hills, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Newport Beach, California, United States
• Study site — Oakland, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Stanford, California, United States
• Study site — Sunnyvale, California, United States
• Study site — Torrance, California, United States
• Study site — Denver, Colorado, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Atlantis, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — North Palm Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Vero Beach, Florida, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.