A Study to Evaluate the Safety and Efficacy of MK-0518 in HIV-Infected Patients Failing Current Antiretroviral Therapies - Full Text View

Purpose

This study will investigate the safety and efficacy of MK-0518 as a therapy for HIV-infected patients failing current therapy.

Condition	Intervention	Phase
HIV Infections	Drug: MK0518 / Duration of Treatment - 48 Weeks Drug: Placebo & Optimized Antiretroviral Background Therapy / Duration of Treatment - 48 Weeks	Phase III

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Raltegravir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least 1 Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies

Further study details as provided by Merck:

Primary Outcome Measures:

Proportion of patients achieving HIV RNA <400 copies/mL at Weeks 24; safety and tolerability assessed by review of the accumulated safety data.

Secondary Outcome Measures:

At Week 24 and Week 48: (a) Proportion of patients with virologic response at week 24; (b) Change from baseline in HIV RNA (log10 copies/mL); (c) Change from baseline in CD4 cell count. (2) Evaluate the antiretroviral activity at Week 48.

Estimated Enrollment:	345
Study Start Date:	February 2006

Eligibility

Ages Eligible for Study:	16 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 have documented failure of certain antiretroviral therapy.
Patient must be on the same antiretroviral therapy for at least the past two months.

Exclusion Criteria:

Patient less than 16 years old
Additional study criteria will be discussed and identified by the study doctor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293267

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Publications indexed to this study:

Cooper DA, Steigbigel RT, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Teppler H, Nguyen BY; BENCHMRK Study Teams. Subgroup and resistance analyses of raltegravir for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):355-65.

Steigbigel RT, Cooper DA, Kumar PN, Eron JE, Schechter M, Markowitz M, Loutfy MR, Lennox JL, Gatell JM, Rockstroh JK, Katlama C, Yeni P, Lazzarin A, Clotet B, Zhao J, Chen J, Ryan DM, Rhodes RR, Killar JA, Gilde LR, Strohmaier KM, Meibohm AR, Miller MD, Hazuda DJ, Nessly ML, DiNubile MJ, Isaacs RD, Nguyen BY, Teppler H; BENCHMRK Study Teams. Raltegravir with optimized background therapy for resistant HIV-1 infection. N Engl J Med. 2008 Jul 24;359(4):339-54.

Study ID Numbers:	2005_096
First Received:	February 14, 2006
Last Updated:	October 6, 2006
ClinicalTrials.gov Identifier:	NCT00293267
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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

Slow Virus Diseases

Immune System Diseases

Lentivirus Infections

Infection

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00293267