Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Reverse Transcriptase Inhibitors

Criteria

Inclusion criteria:

• CD4 cell count greater than or equal to 200 cells/mm3.

• HIV-1 RNA >2000 copies/mL.

• Must have history of NNRTI treatment with subsequent failure and documented evidence of an NNRTI-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine.

• Normal resting 12-lead electrocardiogram.

Exclusion criteria:

• Any history of seizure, CNS toxoplasmosis infection, or any CNS (central nervous system) lesion.

• Chronic diarrhea (>3 loose stools/day).

• An active CDC Category C disease (1993), except cutaneous Kaposi's Sarcoma (KS) not requiring systemic therapy during the trial.

• Less than 4 weeks since stopping anti-retroviral therapy (ART) therapy prior to Day 1.

• Any acute laboratory abnormality.

• Positive for HCV antibody or HepBsAG.

• Active infections requiring therapy in the previous 4 weeks.