Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission

PHASE4CompletedINTERVENTIONAL
Enrollment

408

Participants

Timeline

Start Date

September 5, 2013

Primary Completion Date

December 11, 2018

Study Completion Date

December 11, 2018

Conditions
HIV Infections
Interventions
DRUG

Lamivudine/zidovudine

"Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery\*.~\* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization."

DRUG

Efavirenz

Participants received one 600 mg tablet of efavirenz each night from entry through delivery.

DRUG

Raltegravir

Participants received one 400 mg raltegravir tablet twice a day from entry through delivery.

Trial Locations (19)

10220

Bhumibol Adulyadej Hospital, Bangkok

10700

Siriraj Hospital ,Mahidol University NICHD CRS, Bangkok

26030

Hosp. Geral De Nova Igaucu Brazil NICHD CRS, Rio de Janeiro

33316

South Flordia Childrens Diagnostic & Treatment Center, Fort Lauderdale

38105

St Jude's Children's Research Hospital, Memphis

50100

Chiangrai Prachanukroh Hospital NICHD CRS, Chiang Mai

70118

Tulane University, New Orleans

98195

University of Washington Medical Center, Seattle

C1221ADC

Hosp. General de Agudos Buenos Aires Argentina NICHD CRS, Ciudad de Buenos Aires

Unknown

Fundacion Huesped - Hospital Juan A Fernandez, Buenos Aires

Perinatal HIV Research Unit-Chris Hani Baragwanath Hospital, Soweto

Kilimanjaro Christian Medical Centre (KCMC), Moshi

30.130-100

SOM Federal University Minas Gerais Brazil NICHD CRS, Belo Horizonte

95070-560

Univ. Caxias do Sul Brazil NICHD CRS, Caxias do Sul

91350-200

Hospital Nossa Senhora da Conceicao NICHD CRS, Porto Alegre

20221-903

Hospital Federal dos Servidores do Estado NICHD CRS, Rio de Janeiro

21941-612

Instituto de Puericultura e Pediatria Martagao Gesteira - UFRJ NICHD CRS, Rio de Janeiro

14049-900

Univ. of Sao Paulo Brazil NICHD CRS, São Paulo

00936

San Juan City Hosp. PR NICHD CRS, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Westat

OTHER

NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission | Biotech Hunter | Biotech Hunter