NCT00046332|CompletedPhase 2

A Study Comparing 4 Doses Of GW810781 Versus Placebo In HIV-Infected Patients

A Phase II, Randomized, Placebo-controlled Study to Compare Antiviral Effect, Safety, Tolerability and Pharmacokinetics of Four Oral Doses of S-1360 Versus Placebo Over 10 Days in ART-naive HIV-1 Infected Adults.

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

ITG20001

Study Type

interventional

Target

100

Locations

1 country

Sites

Timeline

RegisteredSep 2002

StartedJun 2002

CompletionJan 2003

Brief Summary

This study will evaluate the drop in viral load over 10 days of treatment with S-1360 versus placebo in HIV-infected patients who have not previously taken anti-HIV medications.

Trial Health

On Track

Trial Health Score

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

Enrollment

100

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Timeline

Completed

Started Jun 2002

Shorter than P25 for phase_2 hiv-infections

Geographic Reach

1 country

23 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

7 months study duration

Study Start

First participant enrolled

June 1, 2002

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2002

Completed

4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2002

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed

Last Updated

February 21, 2013

Status Verified

February 1, 2013

Enrollment Period

7 months

First QC Date

September 26, 2002

Last Update Submit

February 20, 2013

Conditions

HIV Infections

Keywords

Integrase inhibitorsMonotherapyHIV-1 infection

Outcome Measures

Primary Outcomes (1)

Plasma HIV-1 RNA change from baseline by Day 11.

Secondary Outcomes (1)

HIV-1 RNA slope over 11 days; proportion of subjects with treatment-limiting adverse events; change from baseline in CD4+ cell count at Day 11; plasma pharmacokinetics by dose; emergence of viral resistance.

Interventions

GW810781DRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

No prior HIV medications.
HIV infection with viral load \>400-50,000 copies/mL.
CD4 cell count \>50 cells/mm.

You may not qualify if:

Patients requiring medications that cannot be interrupted for the duration of the study.
Abnormal ECG or other chronic health conditions as noted on screening physical exam.
Previous participation in an experimental drug trial(s) within 30 days of the screening visit for this study.

Contact the study team to confirm eligibility.