NCT00067782

A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on Their First PI-Based Antiretroviral Therapy

Completed Phase 3 Last updated 7 April 2011

What this trial tests

Phase 3 trial testing Atazanavir (immediate switch) in HIV Infections. Completed in 1 March 2005.

Timeline

1 December 2002

Primary endpoint
1 March 2005

1 March 2005

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 December 2002
Primary completion	1 March 2005
Estimated completion	1 March 2005
Sites	19 locations across United States

Drugs / interventions tested

• Atazanavir (immediate switch) — full drug profile →
• Atazanavir (Week 24 switch) — full drug profile →

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

16 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Time to virologic rebound for subjects with HIV RNA < 50 c/mL at baseline; Magnitude/ durability of increases from baseline in absolute CD4 (Time-Averaged Difference) through WK12; Mean % change from baseline in fasting LDL cholesterol at WK12.

Sponsor's own description

The purpose of this clinical research study is to learn if atazanavir is associated with serum LDL cholesterol in HIV-infected subjects following a substitution of atazanavir for their previously administered protease inhibitor.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.