Completed

Safety, Tolerability, and Antiviral Activity of GW695634G Monotherapy in HIV-1 Infected Adults

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2004
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2004

Actual date on which the first participant was enrolled.

This study focuses on HIV-1 infected adults who have previously used a specific type of medication called Non-nucleoside reverse transcriptase inhibitor (NNRTI). The main goal is to explore the safety, tolerability, and antiviral effectiveness of a new drug, GW695634G. This research is important as it aims to find a new treatment option for HIV-1 infected individuals, potentially improving their care and quality of life. During this study, participants are randomly assigned to receive one of four different oral doses of GW695634G or a placebo for 10 days. The study measures the changes in HIV-1 levels, CD4+ cell count (a type of white blood cell that fights infection), and how the body processes the drug. The primary outcomes also include evaluating the safety and tolerability of the drug. The study takes place over multiple days, including Days 1 and 7.

Official TitleA 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.
NCT00090077
Principal SponsorGlaxoSmithKline
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus Infections

Criteria

4 inclusion criteria required to participate
HIV-1 RNA >2000 copies/mL.
Normal resting 12-lead electrocardiogram.
CD4 cell count greater than or equal to 200 cells/mm3.
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.
7 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 18 locations

Suspended

GSK Clinical Trials Call Center

Phoenix, United StatesOpen GSK Clinical Trials Call Center in Google Maps
Suspended

GSK Clinical Trials Call Center

Fountain Valley, United States
Suspended

GSK Clinical Trials Call Center

San Francisco, United States
Suspended

GSK Clinical Trials Call Center

West Hollywood, United States
Completed18 Study Centers