Estimate the Effect of Telaprevir and Boceprevir on Maraviroc Pharmacokinetics in Healthy Subjects

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Maraviroc + Telaprevir; Drug: Maraviroc; Drug: Maraviroc + Boceprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01597895

A4001108

Details and patient eligibility

About

The purpose of this study is to determine the effect that telaprevir and boceprevir has on the pharmacokinetics of maraviroc.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
• Total body weight >50 kg (110 lbs).

Exclusion criteria

• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
• Positive result for HIV-1, HIV-2, Hepatitis B serology (HbsAg, HbcAb) or anti hepatitis C virus serology (as determined by a multi antigen EIA).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

14 participants in 3 patient groups

Maraviroc

Active Comparator group

Treatment:

Drug: Maraviroc

Maraviroc + Boceprevir

Experimental group

Treatment:

Drug: Maraviroc + Boceprevir

Maraviroc + Telaprevir

Experimental group

Treatment:

Drug: Maraviroc + Telaprevir