A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)
NCT ID: NCT00100048
Last Updated: 2015-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
206 participants
INTERVENTIONAL
2005-01-31
2010-07-31
Brief Summary
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Detailed Description
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Participants randomized to efavirenz in the base study continued to receive efavirenz at the dosage given in the base study. The doses of open label tenofovir and lamivudine continued unchanged.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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600 mg monotherapy
MK0518 600 mg twice daily
Comparator: MK0518 monotherapy
MK0518 twice daily for 10 days
400 mg monotherapy
MK0518 400 mg twice daily
Comparator: MK0518 monotherapy
MK0518 twice daily for 10 days
200 mg monotherapy
MK0518 200 mg twice daily
Comparator: MK0518 monotherapy
MK0518 twice daily for 10 days
100 mg monotherapy
MK0518 100 mg twice daily
Comparator: MK0518 monotherapy
MK0518 twice daily for 10 days
placebo monotherapy
Placebo to MK0518 twice daily
Placebo monotherapy
Placebo to MK0518 twice daily
600 mg combo therapy
MK0518 600 mg + tenofovir + lamivudine
Comparator: MK0518 combination therapy
MK0518 twice daily for 48 weeks
Comparator: tenofovir
tenofovir 300 mg daily for 48 weeks
Comparator: lamivudine
lamivudine 300 mg daily for 48 weeks
400 mg combo therapy
MK0518 400 mg + tenofovir + lamivudine
Comparator: MK0518 combination therapy
MK0518 twice daily for 48 weeks
Comparator: tenofovir
tenofovir 300 mg daily for 48 weeks
Comparator: lamivudine
lamivudine 300 mg daily for 48 weeks
200 mg combo therapy
MK0518 200 mg + tenofovir + lamivudine
Comparator: MK0518 combination therapy
MK0518 twice daily for 48 weeks
Comparator: tenofovir
tenofovir 300 mg daily for 48 weeks
Comparator: lamivudine
lamivudine 300 mg daily for 48 weeks
100 mg combo therapy
MK0518 100 mg + tenofovir + lamivudine
Comparator: MK0518 combination therapy
MK0518 twice daily for 48 weeks
Comparator: tenofovir
tenofovir 300 mg daily for 48 weeks
Comparator: lamivudine
lamivudine 300 mg daily for 48 weeks
EFV combo therapy
efavirenz + tenofovir + lamivudine
Comparator: efavirenz
efavirenz 600 mg every night at bedtime for 48 weeks
Comparator: tenofovir
tenofovir 300 mg daily for 48 weeks
Comparator: lamivudine
lamivudine 300 mg daily for 48 weeks
Interventions
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Comparator: MK0518 monotherapy
MK0518 twice daily for 10 days
Comparator: MK0518 combination therapy
MK0518 twice daily for 48 weeks
Comparator: efavirenz
efavirenz 600 mg every night at bedtime for 48 weeks
Comparator: tenofovir
tenofovir 300 mg daily for 48 weeks
Comparator: lamivudine
lamivudine 300 mg daily for 48 weeks
Placebo monotherapy
Placebo to MK0518 twice daily
Eligibility Criteria
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Inclusion Criteria
Extension Studies:
* First extension: Patient completed the 48-week base study
* Second extension: Patient completed the first 144-week extension study
Exclusion Criteria
* Individuals who currently do not test positive for HIV
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Markowitz M, Morales-Ramirez JO, Nguyen BY, Kovacs CM, Steigbigel RT, Cooper DA, Liporace R, Schwartz R, Isaacs R, Gilde LR, Wenning L, Zhao J, Teppler H. Antiretroviral activity, pharmacokinetics, and tolerability of MK-0518, a novel inhibitor of HIV-1 integrase, dosed as monotherapy for 10 days in treatment-naive HIV-1-infected individuals. J Acquir Immune Defic Syndr. 2006 Dec 15;43(5):509-15. doi: 10.1097/QAI.0b013e31802b4956.
Murray JM, Emery S, Kelleher AD, Law M, Chen J, Hazuda DJ, Nguyen BY, Teppler H, Cooper DA. Antiretroviral therapy with the integrase inhibitor raltegravir alters decay kinetics of HIV, significantly reducing the second phase. AIDS. 2007 Nov 12;21(17):2315-21. doi: 10.1097/QAD.0b013e3282f12377.
Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, Gilde LR, Wan H, Miller MD, Wenning LA, Teppler H; Protocol 004 Part II Study Team. Rapid and durable antiretroviral effect of the HIV-1 Integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):125-33. doi: 10.1097/QAI.0b013e318157131c.
Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, Campbell H, Strohmaier KM, Wan H, Danovich RM, Teppler H; Protocol 004 Part II Study Team. Sustained antiretroviral effect of raltegravir after 96 weeks of combination therapy in treatment-naive patients with HIV-1 infection. J Acquir Immune Defic Syndr. 2009 Nov 1;52(3):350-6. doi: 10.1097/QAI.0b013e3181b064b0.
Other Identifiers
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2004_096
Identifier Type: -
Identifier Source: secondary_id
0518-004
Identifier Type: -
Identifier Source: org_study_id
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