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

Phase 1

• Conditions: Human Immunodeficiency Virus (HIV) Infection; MedDRA version: 9.1Level: LLTClassification code 10200172Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2007-003133-16-DE
• Lead Sponsor: Schering-Plough Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-20
• Study Completion: 2010-10-27
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

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

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 =4 weeks (with the exception of prophylaxis to prevent mother-to-child transmission) and none in the 8 weeks preceding randomization.

3. A CD4 cell count of =100 cell/mm3 at Screening (or as specified by local treatment guidelines).

4. HIV RNA must be =2000 copies/mL at Screening.

5. Subjects should meet IAS, DHSS, or local recommendations for initiation of ART.

6. Platelet count must be =50,000/µL, hemoglobin =8 g/dL, absolute neutrophil count =1000/µL, serum creatine <2.0 mg/dL (154 µmol/L), and SGOT/SGPT =3 x ULN at Screening. Other clinical laboratory tests must be within normal limits or clinically acceptable to the investigator.

7. Female subjects of childbearing potential must be using a medically accepted method of birth control prior to Screening and agree to continue its use during the study, or must have been surgically sterilized.

8. Female subjects of childbearing potential must have a negative serum beta-hCG (human chorionic gonadotropin) pregnancy test at Screening and a negative urine beta-hCG pregnancy test on Day 2 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) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.