A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Efavirenz; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine, zidovudine drug combination; Reverse Transcriptase Inhibitors; Rilpivirine; Tenofovir

Criteria

Inclusion Criteria:

• Documented human immunodeficiency virus type 1 (HIV-1) infection

• Never been treated with an antiretroviral (ARV) treatment or therapeutic HIV vaccine, or received less than or equal to 2 weeks treatment prior to screening with an nucleoside reverse transcriptase inhibitors

• HIV-1 plasma viral load above 5000 HIV-1 RNA copies per milliliter, at screening

• Cortisol of at least 550 nano moles per liter (19.9 microgram per deciliter) at screening

• Sensitivity to investigator selected nucleosides, at screening

Exclusion Criteria:

• Currently having active Acquired Immunodeficiency Syndrome (AIDS) defining illness

• Known or suspected acute (primary) HIV-1 infection

• Any current or history of adrenal disorder, and an acute hepatitis A, B, or C infection

• Documented genotypic evidence of Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) resistance at screening

• Pregnant or breastfeeding females

• Not agree to protocol-defined effective use of contraception