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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: HIV Infection

Treatments: Drug: Atazanavir + Ritonavir + Combivir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00326716

AI424-182

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Treatment

Experimental group

Treatment:

Drug: Atazanavir + Ritonavir + Combivir