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Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
This study has been completed.
Sponsor:
Gilead Sciences
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00298350
First received: February 28, 2006
Last updated: July 28, 2008
Last verified: July 2008
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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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:
Further study details as provided by Gilead Sciences:
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00298350
Show 54 Study Locations
Sponsors and Collaborators
Gilead Sciences
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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:
|
Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Ritonavir |
HIV Protease Inhibitors Protease Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 21, 2017