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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00745823 |
A study to evaluate the safety, tolerability and efficacy of once daily Raltegravir compared to twice daily raltegravir when each is given in combination with TRUVADA™ in treatment-nave HIV infected patients.
Condition | Intervention | Phase |
---|---|---|
HIV |
Drug: Comparator: MK0518 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Once Daily Raltegravir (MK0518) Versus Twice Daily Raltegravir, Each in Combination With TRUVADA™, in Treatment-Naïve HIV Infected Patients |
Estimated Enrollment: | 750 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
raltegravir
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Drug: Comparator: MK0518
Arm 1: Raltegravir 400 mg tablet PO b.i.d. + two raltegravir placebo tablets + one tablet of TRUVADA™ q.d. (fixed combination 200 mg of emtricitabine 300 mg of tenofovir disoproxil fumarate) Arm 2: raltegravir 800 mg tablets PO q.d. + raltegravir placebo tablets + one tablet of TRUVADA™ q.d. ( fixed combination 200 mg of emtricitabine 300 mg of tenofovir disoproxil fumarate) Treatment period 0f 96 weeks. |
2: Experimental
raltegravir
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Drug: Comparator: MK0518
Arm 1: Raltegravir 400 mg tablet PO b.i.d. + two raltegravir placebo tablets + one tablet of TRUVADA™ q.d. (fixed combination 200 mg of emtricitabine 300 mg of tenofovir disoproxil fumarate) Arm 2: raltegravir 800 mg tablets PO q.d. + raltegravir placebo tablets + one tablet of TRUVADA™ q.d. ( fixed combination 200 mg of emtricitabine 300 mg of tenofovir disoproxil fumarate) Treatment period 0f 96 weeks. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Toll Free Number | 1-888-577-8839 |
Study Director: | Medical Monitor | Merck |
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_543, MK0518-071 |
Study First Received: | September 2, 2008 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00745823 History of Changes |
Health Authority: | United States: Food and Drug Administration |
HIV Infections Treatment Naïve |
Emtricitabine HIV Infections Acquired Immunodeficiency Syndrome Tenofovir Tenofovir disoproxil |