TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is designed to assess the swallowability of uncoated and film-coated 200 mg etravirine tablets in HIV-1 infected patients. In addition, comparisons between a single 200 mg tablet versus two 100 mg formulations will be made. The outcome of the trial will aid in making decisions about the future commercial 200 mg formulation.

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

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Etravirine

Criteria

Inclusion Criteria:

• Women must be postmenopausal for at least 2 years, OR be surgically sterile (have had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of becoming pregnant), OR be not heterosexually active for the duration of the study or have a vasectomized partner (confirmed sterile) OR if of childbearing potential and heterosexually active, be practicing a highly effective method of birth control (as specified below) before entry, and agree to continue to use a highly effective method of contraception throughout the study. Women with tubal ligation are required to use one contraceptive method (Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction)

• All women must have a negative serum or urine pregnancy test at screening. Women of childbearing potential must have a negative urine pregnancy test at other visits

• Men must agree to use a highly effective method of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or non-estrogen hormonal based contraceptives) and to not donate sperm during the study

• Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

• Patient can comply with the protocol requirements

Exclusion Criteria:

• Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the patient or prevent the patient from meeting or performing study requirements

• Any active clinically significant disease (e.g., pancreatitis, cardiac dysfunction) or findings during screening of medical history, laboratory or physical examination that, in the investigator's opinion, would compromise the patient's safety, ability to swallow, or outcome of the trial

• Pregnant or breastfeeding female patient