TMC207-TiDP13-C117: Interaction Study in Human Immunodeficiency Virus-type 1 (HIV-1) Infected Patients With Nevirapine (NVP)

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this Phase I, open-label, single sequence drug-drug interaction trial in human immunodeficiency virus-type 1 infected patients is to investigate the potential interaction between steady-state nevirapine (NVP) 200 mg b.i.d. (twice a day) and a single dose of 400 mg TMC207 and to explore the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec BVBA
• Treatments: Bedaquiline; Diarylquinolines; Nevirapine

Criteria

Inclusion Criteria:

• Documented HIV-1 infection

• Antiretroviral naïve patients, for whom in the judgment of the investigator, it is appropriate to initiate NVP-containing ARV therapy at least 2 but no more than 4 weeks after the first dose of TMC207, based on the patient's medical condition and taking into account local treatment guidelines for the treatment of HIV-1 infection

• Patient agrees not to start ARV therapy until at least 2 weeks after the first dose of TMC207

• patient agrees not to change NVP and N(t)RTI therapy (including dosages) from the start of NVP treatment at 200 mg b.i.d. until Day 15 of Treatment B, unless this is medically indicated as decided by the treating physician.

Exclusion Criteria:

• Female, except if postmenopausal since more than 2 years, or posthysterectomy, or post-surgical sterilization

• Patient has any currently active AIDS defining illness

• Active tuberculosis

• Known or suspected acute HIV-1 infection

• Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, or respiratory disease.