Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Rifabutin; Drug: Lersivirine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00925535

A5271043

Details and patient eligibility

About

Approximately 1/3 of persons living with HIV infection are co-infected with tuberculosis (TB). Rifabutin, used in the treatment of TB, is an inducer of drug metabolism thus may decrease concentrations of lersivirine if co-administered. Lersivirine is a modest inducer of drug metabolism, thus lersivirine may decrease concentrations of rifabutin as well.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
• History of regular alcohol consumption exceeding 7 drinks/week for women and 14 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor).
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
• Hypersensitivity/allergic reactions to any component of the study drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

18 participants in 3 patient groups

Treatment A

Active Comparator group

Description:

Lersivirine

Treatment:

Drug: Lersivirine

Drug: Lersivirine

Treatment B

Active Comparator group

Description:

Rifabutin

Treatment:

Drug: Rifabutin

Drug: Rifabutin

Treatment C

Experimental group

Description:

Lersivirine and Rifabutin

Treatment:

Drug: Rifabutin

Drug: Lersivirine

Drug: Lersivirine

Drug: Rifabutin