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Sponsors and Collaborators: |
Dallas VA Medical Center Funded by academic grant from Merck & Co, Inc. Tibotec Pharmaceutical Limited |
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Information provided by: | Dallas VA Medical Center |
ClinicalTrials.gov Identifier: | NCT00677300 |
The purpose of this study is to determine whether a combination of raltegravir and darunavir is as effective as standard regimens in the treatment of HIV-infected patients who have not previously used antiretroviral drug (treatment naive)
Condition | Intervention | Phase |
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HIV Infections |
Drug: Raltegravir Drug: Darunavir Drug: Ritonavir Drug: Tenofovir/Emtricitabine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Safety and Efficacy of Raltegravir/Darunavir Combination in Antiretroviral-Naive Patients |
Estimated Enrollment: | 80 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental
Will receive Raltegravir (400mg twice daily) + Ritonavir-boosted (100mg once daily) Darunavir (800mg once daily)
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Drug: Raltegravir
400mg P.O. (orally) twice daily for 48 weeks
Drug: Darunavir
800 mg P.O. (orally) once daily
Drug: Ritonavir
100mg once daily
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Group B: Active Comparator
Will receive Tenofovir (300mg once daily) + Emtricitabine (200mg once daily) + Ritonavir-boosted (100mg once daily) Darunavir (800mg once daily)
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Drug: Darunavir
800 mg P.O. (orally) once daily
Drug: Ritonavir
100mg once daily
Drug: Tenofovir/Emtricitabine
300 mg/200 mg P.O. (orally) once daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contact: Roger Bedimo, M.D. | 214-857-0410 | roger.bedimo@va.gov |
Contact: Holly A Wise | 214-857-1415 | holly.wise@va.gov |
United States, Texas | |
Dallas VA Medical Center | |
Dallas, Texas, United States, 75216 |
Principal Investigator: | Roger Bedimo, M.D. | Dallas VA Medical Center |
Responsible Party: | VA North Texas Health Care System ( Roger Bedimo, M.D. - Chief, Infectious Diseases ) |
Study ID Numbers: | Merck 072-00 |
Study First Received: | May 8, 2008 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00677300 |
Health Authority: | United States: Federal Government |
HIV Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral Emtricitabine Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Tenofovir Retroviridae Infections Darunavir Immunologic Deficiency Syndromes Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections |