Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Substudy of P03802 - NA

Conditions: HIV infection

Registration Number: EUCTR2005-001843-49-DE

Lead Sponsor: Schering Plough Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

•Subjects previously enrolled in protocol P03802 must have either:
a) successfully completed the 48-week phase,
b) been randomized to placebo and discontinued early because of
virologic failure or,
c) discontinued from P03802 because of a shift in tropism to R5/X4 mixed phenotype but had a good virologic response and no decrease in CD4 count from baseline.

•Subjects must have acceptable hematologic, renal and hepatic laboratory values.
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

•History of recurrent seizure or CNS condition predisposing to seizure
•Use of agents known to inhibit cytochrome P450 3A4 (eg, ritonavir, etc).
•Use of agents agents known to induce cytochrome P450 3A4 (eg efavirenz, etc)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this treatment protocol is to provide subjects previously enrolled in Schering Plough Protocol No. P03802 with long-term vicriviroc on a compassionate basis for use in combination with background antiretroviral therapy.<br>;Secondary Objective: •Secondary objectives are to assess virologic efficacy and long-term safety and tolerability of vicriviroc;Primary end point(s): The primary endpoint will be long-term safety and tolerability, as reflected in<br>laboratory parameters and clinical status.

Secondary Outcome Measures