Status:
COMPLETED
Pharmacokinetics of Atazanavir/Ritonavir in HIV-1 Infected Pregnant Women
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
HIV Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
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 (HI...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00326716
Start Date
June 1 2006
End Date
August 1 2009
Last Update
November 16 2011
Active Locations (6)
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1
Triple O Medical Services, P.A.
West Palm Beach, Florida, United States, 33401
2
Women's Hospital Of Texas
Houston, Texas, United States, 77054
3
Local Institution
San Juan, Puerto Rico, 00936
4
Local Institution
Soweto, Gauteng, South Africa, 2001