Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women

Completed · Phase 1

Conditions studied: HIV Infection

In brief

To determine what dosing regimen of atazanavir (ATV) / ritonavir (RTV) produces adequate drug exposure during pregnancy compared to drug exposure in historical data in human immunodeficiency virus (HIV) infected participants.

Key facts

Study ID

NCT00326716

Run by

Bristol-Myers Squibb

People needed

69

Starts

2006-06-01

Expected to finish

2009-08-01

Last updated by the study team

2011-11-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• HIV-infected pregnant women
• > 18 years of age
• Between week 12 and 32 gestation
• CD4 > 200 cells/mm³
• Treatment-naive with HIV RNA > 400 c/mL, on HAART with HIV RNA <50 c/mL, or previously treated with ATV (< 3 weeks) with HIV RNA>400 c/mL

Where it is running

• Triple O Medical Services, P.A. — West Palm Beach, Florida, United States
• Women's Hospital Of Texas — Houston, Texas, United States
• Local Institution — San Juan, Puerto Rico
• Local Institution — Soweto, Gauteng, South Africa
• Local Institution — Sunnyside, Gauteng, South Africa
• Local Institution — Westdene, Gauteng, South Africa

Full record on ClinicalTrials.gov

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