Option B+: Study on Safety, Viral Suppression, and Survival on Second Line ART
NCT02249962 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12011
Last updated 2021-03-12
Summary
To characterize safety, durability, antiretroviral treatment (ART) resistance, and clinical outcomes for mothers and infants exposed to the efavirenz-based Option B+ regimen for Prevention of Mother to Child Transmission (PMTCT) and HIV treatment in Malawi.
Conditions
- HIV
- Infant Exposure to Efavirenz
Sponsors & Collaborators
-
Ministry of Health and Population, Malawi
collaborator OTHER_GOV -
University of North Carolina
collaborator OTHER -
Lighthouse Trust
collaborator OTHER -
Baylor College of Medicine
collaborator OTHER -
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
University of North Carolina, Chapel Hill
lead OTHER
Principal Investigators
-
Mina C Hosseinipour, MD, MPH · UNC Project- Malawi
Eligibility
- Min Age
- 16 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2020-09-30
- Completion
- 2020-09-30
Countries
- Malawi
Study Locations
More Related Trials
-
HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV
NCT00442962 ·Status: COMPLETED ·Phase: PHASE4
-
Supporting Oral and Long-acting PrEP Decision Making Among Pregnant Women in Lilongwe, Malawi
NCT06397690 ·Status: COMPLETED ·Phase: NA
-
UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
NCT06158126 ·Status: RECRUITING ·Phase: PHASE4
-
Early Infant HIV Treatment in Botswana
NCT02369406 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
Evaluating the Efficacy and Safety of Dolutegravir-Containing Versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and Their Infants
NCT03048422 ·Status: COMPLETED ·Phase: PHASE3
-
Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection
NCT01854762 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
DTG Plus 3TC for Prophylaxis of Mother-to-child Transmission of HIV Infection in Pregnant Women
NCT04808973 ·Status: COMPLETED ·Phase: PHASE3
-
Nevirapine Resistance Study: Nevirapine Resistance Among HIV-Infected Mothers
NCT00164762 ·Status: COMPLETED
-
Extended Infant Post-exposure Prophylaxis With Antiretrovirals to Reduce Postnatal HIV Transmission
NCT00115648 ·Status: COMPLETED ·Phase: PHASE3
-
Long Term Outcomes of Therapy in Women Initiated on Lifelong ART Because of Pregnancy in DR Congo
NCT03048669 ·Status: COMPLETED ·Phase: NA
-
Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
NCT00000828 ·Status: COMPLETED
-
Evaluation of the Population-level Impact of PMTCT Option B+ in Zimbabwe
NCT03388398 ·Status: COMPLETED
-
Optimizing PrEP Regimens for Pregnant Women in Sub-Saharan Africa (O-PrEP Study) - Stage 1
NCT06435026 ·Status: COMPLETED ·Phase: PHASE2
-
Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
NCT00028145 ·Status: COMPLETED
-
Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia
NCT00753324 ·Status: COMPLETED ·Phase: PHASE4
-
Dolutegravir in Pregnant HIV Mothers and Their Neonates
NCT03249181 ·Status: COMPLETED ·Phase: PHASE3
-
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
NCT00993031 ·Status: COMPLETED ·Phase: PHASE3
-
An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women
NCT04330989 ·Status: COMPLETED ·Phase: NA
-
Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study
NCT02245022 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies
NCT00000888 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of a Differentiated Point-of-care Active Case Finding & Management Model to Eliminate Mother-to-Child Transmission of HIV in Malawi
NCT06493357 ·Status: RECRUITING ·Phase: NA
-
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
NCT01618305 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Ritonavir (an Anti-HIV Drug) in HIV-Positive Infants and Children
NCT00000952 ·Status: COMPLETED ·Phase: PHASE1
-
Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy
NCT00017719 ·Status: COMPLETED ·Phase: PHASE3
-
An Intervention to Improve Antenatal Access to CD4 Testing and HAART in Botswana
NCT01836003 ·Status: COMPLETED ·Phase: NA