NCT00090077|CompletedPhase 1

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.

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

NN210005

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredAug 2004

StartedApr 2004

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach

1 country

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2004

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2004

Completed

Last Updated

February 27, 2006

Status Verified

February 1, 2006

First QC Date

August 24, 2004

Last Update Submit

February 24, 2006

Conditions

HIV Infections

Keywords

GW695634GGW695634XGW678248XpharmacokineticsNNRTIHIV

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

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

Interventions

GW695634DRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.