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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

HIV Infections

Treatments

Drug: GW695634

Study type

Interventional

Funder types

Industry

Identifiers

NCT00090077

NN210005

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.