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

Purpose

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.

Condition	Intervention	Phase
HIV HIV-1 Human Immunodeficiency Virus	Drug: GS-9137 - A Novel HIV-1 Integrase Inhibitor	Phase 2


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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Proteinase inhibitor Elvitegravir

U.S. FDA Resources

Further study details as provided by Gilead Sciences:


Enrollment:	278
Study Start Date:	February 2006
Study Completion Date:	July 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298350

Show 54 Study Locations

Sponsors and Collaborators

Gilead Sciences

More Information

Additional Information:

Gilead Website This link exits the ClinicalTrials.gov site

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Zolopa AR, Berger DS, Lampiris H, Zhong L, Chuck SL, Enejosa JV, Kearney BP, Cheng AK. Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV Type 1: results of a phase 2, randomized, controlled, dose-ranging clinical trial. J Infect Dis. 2010 Mar 15;201(6):814-22. doi: 10.1086/650698.


Responsible Party:	Kitty Yale, Gilead Sciences INC
ClinicalTrials.gov Identifier:	NCT00298350 History of Changes
Other Study ID Numbers:	GS-US-183-0105
Study First Received:	February 28, 2006
Last Updated:	July 28, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:


Phase 2 Phase II Randomized Controlled Comparator Partially Blind Protease Inhibitors Integrase Inhibitors	Antiviral Agents Antiretroviral Agents ART ARV Highly Activity Antiretroviral Therapy HAART Treatment Experienced

Additional relevant MeSH terms:


Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Virus Diseases	HIV Protease Inhibitors Integrase Inhibitors Protease Inhibitors Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015