A Study Of Different Doses Of UK-453, 061 Plus Truvada Compared To Efavirenz Plus Truvada In Patients Who Have Not Been Previously Treated For HIV-1

Pfizer

Status and phase: Completed; Phase 2

Conditions: HIV-1

Treatments: Drug: UK-453, 061; Drug: EFV +TVA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00824421

A5271015

Details and patient eligibility

About

This is a 96 week study to determine if UK- 453,061 in combination with Truvada is as efficacious, safe and tolerable as efavirenz in combination with Truvada in HIV-1 infected patients who have not been previously treated with antiretroviral drugs.

Enrollment: 195 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
• HIV 1 RNA viral load of greater then 1,000 copies/mL
• Negative urine pregnancy test.

Exclusion criteria

• Suspected or documented active, untreated HIV-1 related opportunist infection or other condition requiring acute therapy at the time of randomization.
• Subjects with acute Hepatitis B and/or C within 30 days of randomization.
• Absolute CD4 count <200 cells/mm3.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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195 participants in 3 patient groups

UK- 453,061 Dose One

Experimental group

Description:

UK 453,061 Dose One plus Truvada

Treatment:

Drug: UK-453, 061

Drug: UK-453, 061

UK-453,061 Dose Two

Experimental group

Description:

UK 453,061 Dose Two plus Truvada

Treatment:

Drug: UK-453, 061

Drug: UK-453, 061

Efavirenz + Truvada

Active Comparator group

Description:

Efavirenz + Truvada

Treatment:

Drug: EFV +TVA