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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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

Key facts

Study ID

NCT00090077

Run by

GlaxoSmithKline

People needed

50

Starts

2004-04-01

Last updated by the study team

2006-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Clinical Trials Call Center — Phoenix, Arizona, United States
• GSK Clinical Trials Call Center — Fountain Valley, California, United States
• GSK Clinical Trials Call Center — San Francisco, California, United States
• GSK Clinical Trials Call Center — West Hollywood, California, United States
• GSK Clinical Trials Call Center — Washington D.C., District of Columbia, United States
• GSK Clinical Trials Call Center — Fort Lauderdale, Florida, United States
• GSK Clinical Trials Call Center — Miami, Florida, United States
• GSK Clinical Trials Call Center — Miami Beach, Florida, United States
• GSK Clinical Trials Call Center — Orlando, Florida, United States
• GSK Clinical Trials Call Center — Vero Beach, Florida, United States
• GSK Clinical Trials Call Center — Atlanta, Georgia, United States
• GSK Clinical Trials Call Center — Boston, Massachusetts, United States
• GSK Clinical Trials Call Center — Las Vegas, Nevada, United States
• GSK Clinical Trials Call Center — New York, New York, United States
• GSK Clinical Trials Call Center — Charlotte, North Carolina, United States
• GSK Clinical Trials Call Center — Oklahoma City, Oklahoma, United States
• GSK Clinical Trials Call Center — Fort Worth, Texas, United States
• GSK Clinical Trials Call Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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