Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV

PHASE2CompletedINTERVENTIONAL
Enrollment

452

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2016

Conditions
HIV Infections
Interventions
DRUG

Lamivudine

4 mg/kg twice daily

DRUG

Lopinavir/ritonavir

16/4 mg/kg twice daily for participants 2 months of age to less than 6 months of age; 12/3 mg/kg twice daily for participants at least 6 months of age and weighing less than 15 kg; 10/2.5 mg/kg twice daily for participants at least 6 months of age and weighing between 15 kg and 40kg; 400/100 mg twice daily for participants weighing more than 40 kg

DRUG

Nevirapine

Initially: 4 mg/kg for 14 days, then 7 mg/kg twice daily. In protocol version 2.0, Letter of Amendment 1 (September 2007), NVP dose increased to conform with WHO guidelines to: 160 to 200 mg/m\^2/dose to max 200 mg once daily for 14 days, then 160 to 200 mg/m\^2/dose to max 200 mg twice daily

DRUG

Zidovudine

180 mg/m\^2 twice daily

Trial Locations (10)

2013

Harriet Shezi Clinic at Chris Hani Baragwanath Hospital, Johannesburg

7700

University of Stellenbosch-Tygerberg Hospital, South Africa, Cape Town

50202

Nelson R. Mandela School of Medicine, University of Kwazulu, Natal

411001

BJ Medical College CRS, Pune

Unknown

University of North Carolina Lilongwe CRS, Mzimba Road

Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Johannesburg

Kilimanjaro Christian Medical CRS, IDC Research Offices

Makerere University, Kampala

George Clinic CRS, Lusaka

UZ-College of Health Sciences, Harare

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

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

NIH

lead

International Maternal Pediatric Adolescent AIDS Clinical Trials Group

NETWORK

NCT00307151 - Antiviral Responses to NNRTI-Based vs. PI-Based ARV Therapy in HIV Infected Infants Who Have or Have Not Received Single Dose NVP for Prevention of Mother-to-Child Transmission of HIV | Biotech Hunter | Biotech Hunter