Status:
TERMINATED
Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection
Lead Sponsor:
Fundação Bahiana de Infectologia
Conditions:
HIV
Pregnancy
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
PHASE3
Brief Summary
The current available antiretroviral (ARV) agents make possible a successful treatment of virtually all HIV-infected patients, even those heavily experienced subjects, with a history of previous failu...
Detailed Description
A total of 44 late-presenters (gestational age \>28 weeks), HIV-infected pregnant women will be randomly assigned to receive an antiretroviral regimen based on Zidovudine (AZT)+Lamivudine (3TC)+Ralteg...
Eligibility Criteria
Inclusion
- Pregnant women with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA \>1,000 copies/ml)
- Gestational age higher than 28 weeks
- Age equal or higher than 15 years
- HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml
Exclusion
- Age lower than 15 years
- Undetectable plasma viral load at screening
- Previous use of RAL
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01854762
Start Date
June 1 2015
End Date
August 2 2017
Last Update
October 15 2024
Active Locations (1)
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1
Fundação Bahiana de Infectologia/SEI
Salvador, Estado de Bahia, Brazil, 40110-010