Safety and Efficacy of an Investigational Drug in HIV-Infected Patients Failing Current Antiretroviral Therapies

This study is ongoing, but not recruiting participants.

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00105157

Purpose

This study will investigate the safety and efficacy of different doses of an investigational drug as a therapy for HIV-infected patients failing current antiretroviral therapies.

Condition	Intervention	Phase
HIV Infections Acquired Immunodeficiency Syndrome	Drug: MK0518 Drug: Comparator: placebo	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Raltegravir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter Study to Evaluate the Safety and Efficacy of MK-0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance

Further study details as provided by Merck:

Primary Outcome Measures:

All accumulated safety data through Week 24; Change from baseline in HIV RNA levels at Week 24.

Secondary Outcome Measures:

At Week 24: proportion of patients with HIV RNA levels <400 and 50 copies/mL; change from baseline in CD4 cell count.

Estimated Enrollment:	200
Study Start Date:	April 2005

Detailed Description:

The duration of treatment is 48 weeks.

Eligibility

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

Criteria

Inclusion Criteria:

Patient must be HIV positive with HIV RNA values that are within ranges required by the study.
Patient must be currently on antiretroviral therapy (ART).

Exclusion Criteria:

Patient less than 18 years of age.
Additional exclusion criteria will be discussed and identified by the study doctor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105157

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications indexed to this study:

Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-9.

Study ID Numbers:	2005_007
Study First Received:	March 8, 2005
Last Updated:	October 6, 2006
ClinicalTrials.gov Identifier:	NCT00105157
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Pathologic Processes
Disease
Slow Virus Diseases

Immune System Diseases
Syndrome
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009