At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 69 enrolled
Drug / intervention
Atazanavir + Ritonavir + Combivirdrug
Likely dose
Atazanavir + Ritonavir + Combivir 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study of the Pharmacokinetics of Atazanavir (ATV)/Ritonavir(RTV) Administered as Part of Highly Active Antiretroviral Therapy (HAART) in HIV-1 Infected Pregnant Women
In Brief
A Phase 1 clinical trial evaluating Atazanavir + Ritonavir + Combivir for HIV Infection. Completed, enrolled 69 participants across 6 sites in 3 countries.
Detailed 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 (HIV) infected participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection
CountriesPuerto Rico, South Africa, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2006
Enrollment StartJun 2006
Primary CompletionJan 2009
Study CompletionAug 2009
TodayJul 2026
First PostedMay 17, 2006
Enrollment StartJun 1, 2006
Primary CompletionJan 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 20.1 years ago
Interventions
Atazanavir + Ritonavir + Combivirdrug
Capsules, tablets, Oral, initially ATV 300 mg + RTV 100 mg + ZDV/3TC 300/150 mg, dose escalated to ATV 400 mg + RTV 100 mg + ZDV/3TC 300/150 mg, ATV and RTV once daily, lamivudine (ZDV) / zidovudine (3TC) twice daily (BID), up to 36 weeks