A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00745823

Purpose

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-na?ve 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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir Truvada

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

HIV RNA <50 copies/ml, evaluation of safety and tolerability [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

HIV RNA <50 copies/ml, evaluation of safety and tolerability [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	750
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator raltegravir	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	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.

Arms

Assigned Interventions

1: Active Comparator

raltegravir

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is male or female 18 years of age or older
Patient is HIV positive
Patient is naïve to antiretroviral therapy (ART) or has received less than 7 days total of any ART

Exclusion Criteria:

Patient is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
Patient has documented resistance to tenofovir or emtricitabine
Patient is currently participating or has participated in a study with an investigational compound or device within 45 days of signing informed consent
Patient is pregnant or breastfeeding, or expecting to conceive

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745823

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

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:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00745823 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

HIV Infections
Treatment Naïve

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors

Antiviral Agents
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors
Tenofovir disoproxil

ClinicalTrials.gov processed this record on November 20, 2009