Status:
COMPLETED
Monotherapy Versus Placebo Over 7 Days-Non-Nucleoside Reverse Transcriptase Inhibitor-Experienced HIV1 Infected Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To investigate safety, tolerability and antiviral activity in Non-nucleoside reverse transcriptase inhibitor (NNRTI)-experienced HIV-1 infected patients
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00090077
Start Date
April 1 2004
Last Update
February 27 2006
Active Locations (18)
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1
GSK Clinical Trials Call Center
Phoenix, Arizona, United States, 85006
2
GSK Clinical Trials Call Center
Fountain Valley, California, United States, 92708
3
GSK Clinical Trials Call Center
San Francisco, California, United States, 94115
4
GSK Clinical Trials Call Center
West Hollywood, California, United States, 90069