Phase 2 N=29 Randomized Double-blind Treatment

A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061

HIV-1

Bottom Line

View on ClinicalTrials.gov: NCT00348673 ↗

Enrolled (actual)

Serious AEs

2.1%

Results posted

Oct 2013

Primary outcome: Primary: Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8 — 4.57; 4.39; 4.41; 4.38 log10 copies/mL

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: UK-453,061 (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Pfizer
Primary completion: Feb 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Human Immunodeficiency Virus-1 (HIV-1) Viral Load at Day 8	4.57; 4.39; 4.41; 4.38; 4.65; 4.55	—
SECONDARY Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load	0; 1; 0; 0; 0; 0	—

Summary

A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability of UK-453,061 in asymptomatic HIV infected subjects.

Eligibility Criteria

Inclusion Criteria

Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive.
Patients with virus not containing NNRTI resistant mutations as determined by the VircoGEN virtual phenotyping essay.

Exclusion Criteria

Patients with a CD4 count less than 250 cells/mm3.
Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for whom there is evidence of recent seroconversion.
Patients with an HIV viral load less than 5000 copies/ml using RT-PCR(Roche Amplicor v1.5).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00348673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.