Multicenter, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Antiretroviral Activity of L-000900612 in Combination With an Optimized Background Therapy (OBT), Versus Optimized Background Therapy Alone, in HIV-Infected Patients With Documented Resistance to at Least One Drug in Each of the 3 Classes of Licensed Oral Antiretroviral Therapies - Dose-Ranging Study in HIV-Infected Patients With Documented Resistance to Antiretroviral Therapies

Phase 1

• Conditions: nspecified human immunodeficiency virus [HIV] disease; MedDRA version: 7.0Level: LLTClassification code 10020162

• Registration Number: EUCTR2004-005037-19-DK
• Lead Sponsor: Merck Sharp & Dohme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-10
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

a. Patient is HIV positive as determined by a positive ELISA and has screening plasma HIV RNA (determined by the central laboratory) >5,000 copies/mL within 35 days prior to the treatment phase of this study.
b.Patient has a screening CD4 cell count >50 cells/mm3 (determined by the central laboratory) within 35 days prior to the treatment phase of this study.
c.Patient is ART experienced and on stable ART for >3 months.
d.Patient has HIV with documented reduced susceptibility to at least one drug in each of the 3 classes of licensed oral ARTs (NNRTI + NRTI + PI) as per genotypic/phenotypic resistance report (PhenoSense GT) from the central laboratory.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Patient has used another experimental HIV-integrase inhibitor
b.Patient requires use of NNRTI (Efavirenz, Nevirapine, Delavirdine) in OBT
c.Patient has any condition or prestudy laboratory abnormality, or history of any illness, which, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs to the patient.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified