Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects - P04875

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003133-16-IT

Enrollment

Registered

2007-11-19

Start date

2008-02-15

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 IN NAIVE PATIENTS MedDRA version: 9.1 Level: LLT Classification code 10020161 Term: HIV infection

Interventions

Product Name: VICRIVIROC Product Code: SCH417690 Pharmaceutical Form: Tablet Current Sponsor code: SCH417690 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Tr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult subjects (≥18 years or minimum age that defines an adult as determined by local regulatory authorities or legal requirements) of either sex or any race with CCR5-tropic HIV infection. 2. Cumulative lifetime anti-retroviral therapy exposure of =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Female subjects of childbearing potential who are breastfeeding, pregnant, or planning to become pregnant. 2. Subjects with intercurrent illness, vaccinations, or who have used immunomodulators (within the 4-week period prior to randomization) that could influence plasma HIV RNA levels. 3. CXCR4 or dual-mixed (CXCR4 and CCR5) tropism. 4. Subjects with primary resistance mutations to any of proposed components of the study arms. 5. Subjects with active opportunistic infection or malignancy. 6. 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 for seizures.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the virologic efficacy of vicriviroc (VCV) combined with ritonavir-boosted Reyataz in human immunodeficiency virus (HIV)-infected treatment-naïve subjects.;Secondary Objective: To assess the long-term safety and tolerability of VCV, and to explore the relationshipof plasma drug concentrations (pharmacokinetics) to virologic response.;Primary end point(s): Mean change from baseline in log10 HIV RNA at Week 48.	—

Measure

Time frame

Main Objective: To evaluate the virologic efficacy of vicriviroc (VCV) combined with ritonavir-boosted Reyataz in human immunodeficiency virus (HIV)-infected treatment-naïve subjects.;Secondary Objective: To assess the long-term safety and tolerability of VCV, and to explore the relationshipof plasma drug concentrations (pharmacokinetics) to virologic response.;Primary end point(s): Mean change from baseline in log10 HIV RNA at Week 48.

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Countries

Germany, Italy, Portugal, Spain

Outcome results

None listed

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