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| Sponsor: | Dallas VA Medical Center |
|---|---|
| Collaborators: |
Merck Tibotec Pharmaceutical Limited |
| Information provided by: | Dallas VA Medical Center |
| ClinicalTrials.gov Identifier: | NCT00677300 |
Purpose
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 |
|---|---|---|
|
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: | January 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group A: Experimental
Will receive Raltegravir (400mg twice daily) + Ritonavir-boosted (100mg once daily) Darunavir (800mg once daily)
|
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
|
|
Group B: Active Comparator
Will receive Tenofovir (300mg once daily) + Emtricitabine (200mg once daily) + Ritonavir-boosted (100mg once daily) Darunavir (800mg once daily)
|
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| 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 | Recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Roger Bedimo, M.D. 214-857-0410 roger.bedimo@va.gov | |
| Contact: Holly A Wise 214-857-1415 holly.wise@va.gov | |
| Principal Investigator: | Roger Bedimo, M.D. | Dallas VA Medical Center |
More Information
| 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: | January 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00677300 History of Changes |
| Health Authority: | United States: Federal Government |
|
HIV Treatment Naive |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Darunavir Emtricitabine Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections RNA Virus Infections HIV Protease Inhibitors Anti-HIV Agents |
Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases Ritonavir HIV Infections Sexually Transmitted Diseases Lentivirus Infections |