Status:
COMPLETED
TMC207-TiDP13-C117: Interaction Study in Human Immunodeficiency Virus-type 1 (HIV-1) Infected Patients With Nevirapine (NVP)
Lead Sponsor:
Tibotec BVBA
Conditions:
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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...
Detailed Description
TMC207 is being investigated for the treatment of M. tuberculosis (TB) infection. This is a Phase I, open-label (both participant and investigator know the name of the assigned medication), single-seq...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00910806
Start Date
June 1 2009
End Date
June 1 2010
Last Update
April 2 2014
Active Locations (1)
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1
George, South Africa