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

Pfizer

Status and phase: Completed; Phase 2

Conditions: HIV-1

Treatments: Drug: UK-453,061

Study type: Interventional

Funder types: Industry

Identifiers

NCT00348673

A5271010

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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49 participants in 2 patient groups

Stage 1

Experimental group

Treatment:

Drug: UK-453,061

Drug: UK-453,061

Stage 2

Experimental group

Treatment:

Drug: UK-453,061

Drug: UK-453,061