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

A Phase I, Multicenter, Randomized, Parallel, Double-Blinded Dose Ranging, Placebo-Controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Dosage Regimens of GW695634G Monotherapy Versus Placebo Over 10 Days in ART-Naive HIV-1 Infected Adults.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00090077

Enrollment

Registered

2004-08-26

Start date

2004-04-30

Completion date

Unknown

Last updated

2006-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

GW695634G, GW695634X, GW678248X, pharmacokinetics, NNRTI, HIV

Brief summary

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

Interventions

DRUGGW695634

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Safety & tolerability parameters Change from baseline in plasma HIV-1 RNA Change from baseline in CD4+ cell count Plasma GW678248X pharmacokinetic parameters Days 1 & 7	—

Secondary

Measure	Time frame
Plasma GW695634X pharmacokinetic parameters on Day 1 and Day 7 Exploratory relationship of pharmacokinetic parameters to changes in virology, immunology and/or safety assessments	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026