Optimizing Susceptibility to CCR5 Antagonist Response - OSCAR

• Conditions: HIV infection; MedDRA version: 9.1Level: LLTClassification code 10008922

• Registration Number: EUCTR2010-018709-12-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects must be at least 18 years of age at the time of randomization, of either sex and of any race. - Treatment-experienced subjects. - Failing current antiretroviral therapy (HAART). - Genotyping sensitivity score (GSS)>1. - HIV-RNA≥ 500 copies/ml at Screening. - Platelet count must be ≥ 75000/mL, hemoglobin ≥ 9 g/dL, serum creatinine < 2 mg/dL, and AST and ALT ≤ 3 x ULN at Screening. - Subjects must have given written informed consent and must be able to adhere to dose and visit schedules. - Female subjects of child-bearing potential must agree to use a medically accepted method of contraception. - Female subjects of child-bearing potential must have a negative serum beta-hCG pregnancy test at Screening, and a negative urine beta-hCG pregnancy test on Day 1 prior to dosing.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Female subjects of childbearing potential who are breastfeeding, pregnant, or planning to become pregnant. - Subjects with active opportunistic infection or malignancy. - Subjects with intercurrent illness, vaccinations, or who have used immunomodulators that could influence plasma HIV-RNA levels within the 4-week period prior the randomization. - Subjects with seizure disorder requiring ongoing anti-seizure therapy or with a history of a seizure disorder who are, in the judgment of the investigator, at risk of seizures. - Subjects with known liver cirrhosis. - Subjects with any clinically significant condition or situation other than the condition being studied that, in the opinion of investigator, would interfere with the study evaluations or optimal participation. - Subjects with allergy/sensitivity to drugs or its excipients.

Study & Design

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