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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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00046332
Enrollment
100
Registered
2002-09-30
Start date
2002-06-30
Completion date
2003-01-31
Last updated
2013-02-21

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

Conditions

HIV Infections

Keywords

Integrase inhibitors, Monotherapy, HIV-1 infection

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.

Interventions

DRUGGW810781

Sponsors

Shionogi
CollaboratorINDUSTRY
GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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.—

Countries

United States

Outcome results

None listed

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