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

HIV Clinical Trial

Official title:

Phase 2 Study of the Treatment of Antiretroviral Treatment-Experienced Subjects Comparing Ritonavir-Boosted GS-9137 (GS-9137/r) vs. a Comparator Ritonavir-Boosted Protease Inhibitor (CPI/r) in Combination With Background ART.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298350
• Other study ID #: GS-US-183-0105
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2006
• Last updated: July 28, 2008
• Start date: February 2006
• Est. completion date: July 2007

Study information

• Verified date: July 2008
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: July 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV
• HIV Infections
• HIV-1
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• GS-9137 - A Novel HIV-1 Integrase Inhibitor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Puerto Rico, 

External Links

•   Gilead Website