Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
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ClinicalTrials.gov Identifier: NCT00298350 |
Recruitment Status
:
Completed
First Posted
: March 2, 2006
Last Update Posted
: July 29, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV HIV-1 Human Immunodeficiency Virus | Drug: GS-9137 - A Novel HIV-1 Integrase Inhibitor | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 278 participants |
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. |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | June 2007 |
Actual Study Completion Date : | July 2007 |


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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298350

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 |
First Posted: | March 2, 2006 Key Record Dates |
Last Update Posted: | July 29, 2008 |
Last Verified: | July 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 |