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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001843-49-DE

Enrollment

Registered

2005-08-05

Start date

2005-09-13

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV infection

Interventions

Product Name: SCH-417690 Product Code: SCH-417690 Pharmaceutical Form: Tablet INN or Proposed INN: vicriviroc Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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. ;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 laboratory parameters and clinical status.	—

Measure

Time frame

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. ;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 laboratory parameters and clinical status.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026