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OpenTrials
Completed

NCT Number: NCT00298350

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV-1 Human Immunodeficiency Virus Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

GS-9137 - A Novel HIV-1 Integrase Inhibitor

Drug

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 2, 2006
Registry last updated
Jul 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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