Clinical trials: Perinatal HIV Infection
Disease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission
Trial of Three Neonatal Antiretroviral Regimens for Prevention of Intrapartum HIV Transmission
Giving anti-HIV medications to babies born of HIV positive mothers right after birth can lower the babies' risk of contracting HIV.
- Conditions
- Disease Transmission, Vertical, Vertical Human Immunodeficiency Virus Transmission, HIV Infections
- Trial name
- NCT00099359
- Testing
- Zidovudine, Nevirapine (NVP), Epivir (3TC)
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 1,735 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
HIV Infections, HIV/AIDS
Evaluating the Feasibility of Point of Care Birth Testing in Eswatini
This study aims to assess the feasibility and utility of birth testing using point-of-care (POC) testing in maternity settings in Eswatini.
- Conditions
- HIV Infections, HIV/AIDS, Pediatric HIV Infection, Transmission, Perinatal Infection
- Trial name
- NCT04206878
- Testing
- Point-of-care birth test
- Where
- Eswatini
- Volunteers
- 3,316 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
Maternal-fetal Infection Transmission
Prevention of Perinatal Transmission of HIV-1 Without Nucleoside Reverse Transcriptase Inhibitors
The overall goal is to study the feasibility of darunavir/ritonavir (DRV/r) monotherapy as treatment simplification (switch) in pretreated pregnant women, associated with neonatal prophylaxis with nevirapine, constituting a PMTCT…
- Trial name
- MONOGEST (NCT02738502)
- Testing
- darunavir monotherapy
- Where
- 23 sites in France
- Volunteers
- 91 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections, Pregnancy Related
HIV Testing Strategies in the Perinatal Setting
The purpose of the study is to determine whether an abbreviated pretest/post-test CDC recommended counseling is as equally acceptable to prenatal patients as the standard strategy using prenatal care nurses and medical providers…
- Trial name
- NCT00503308
- Testing
- Abbreviated HIV test counseling
- Where
- United States
- Volunteers
- 281 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV Infections, Depression
Integrating HIV and Depression Self-Care to Improve Adherence in Perinatal Women
Depression is a common perinatal complication that can have a profound, adverse effect on maternal and child health outcomes. The proposed study will directly address this important, but understudied area by evaluating the…
- Trial name
- NCT03016546
- Testing
- BEST-maCARE, Attention Control Condition
- Where
- India
- Volunteers
- 40 people
- Sponsor
- Yale University
HIV
A Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1
The purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) in infants born to mothers living with HIV-1.
- Trial name
- NCT05406583
- Testing
- Dolutegravir 0.5 mg/kg liquid suspension (starts at 0-5 days of life), Dolutegravir 5 mg Dispersible Tablets (single doses), Dolutegravir 5 mg Dispersible Tablets (chronic dose)
- Where
- 15 sites in United States, South Africa and 1 more
- Volunteers
- 96 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, H1N1 Influenza Virus
Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus.
- Trial name
- NCT00992017
- Testing
- Influenza A (H1N1) monovalent vaccine
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 130 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Pregnancy
Shortened Zidovudine Regimens to Prevent Mother-to-Child Transmission of HIV Type 1
The purpose of the study was to test the equivalence of a short zidovudine (ZDV) regimen as compared to a longer, ACTG-076-like, ZDV regimen in reducing the risk of mother-to-child transmission of HIV: and to assess and compare…
- Trial name
- NCT00386230
- Testing
- ZDV Short (mother)-Short (infant): Comparison of zidovudine durations, ZDV Short (mother)-Long (infant): Comparison of zidovudine durations, ZDV Long (mother)-Short (infant): Comparison of zidovudine durations
- Where
- Thailand
- Volunteers
- 1,554 people
- Sponsor
- Institut de Recherche pour le Developpement
HIV Infections
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth
The purpose of this study is to determine which of 3 different anti-HIV drug regimens given to HIV infected pregnant women during and after their pregnancies is most effective in reducing the incidence of nevirapine (NVP)…
- Trial name
- NCT00109590
- Testing
- Didanosine, enteric-coated, Lopinavir/ritonavir, Nevirapine
- Where
- 7 sites in Thailand
- Volunteers
- 175 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
A Study of Zidovudine in Infants Exposed to the HIV Before or Soon After Birth
To determine if intravenous (IV) and oral zidovudine (AZT) can be safely given to children aged 1 day to 3 months who were born to mothers with an HIV infection. Also to determine the correct dose of AZT for young children.
- Trial name
- NCT00001007
- Testing
- Zidovudine
- Where
- 6 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Prenatal Care
HIV With Innovative Group Antenatal Care in Two African Countries
The quality of antenatal care (ANC) in much of sub-Saharan Africa is constrained by severe resource and staffing shortages. The investigators adapted and piloted an evidence-based model of group antenatal care as an innovative…
- Trial name
- NCT02999334
- Testing
- Group Antenatal Care
- Volunteers
- 218 people
- Sponsor
- University of Illinois Chicago
HIV
Quality of Life Related to the Care of Women Living With HIV During the Perinatal Period
"The improvement of patient care by assessing the Quality of Life Related to Care (QLRC) in pregnant women living with HIV is of great importance for informing decision-making, resource allocation, and health policy formulation…
- Trial name
- QUASOVIH (NCT06666530)
- Testing
- Questionary
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
HIV
NISDI Pediatric Latin American Countries Epidemiologic Study (PLACES): A Prospective Observational Study of HIV-Infected Children at Clinical Sites in Latin American Countries
This is an observational, prospective cohort study to describe the demographic, clinical, immunologic, and virologic characteristics of HIV-infected children at participating clinical sites in Latin American countries.
- Trial name
- NCT00339612
- Where
- 14 sites in Brazil, Mexico and 1 more
- Volunteers
- 2,129 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Cytomegalovirus Congenital, Hearing Loss
Epidemiology of Congenital Cytomegalovirus in a High HIV Prevalence Setting, South Africa
The aim of this project is to determine the epidemiology of congenital cytomegalovirus (CMV) infection and incidence of subsequent permanent neurological sequelae in a high HIV prevalent setting in Soweto, Johannesburg.
- Conditions
- Cytomegalovirus Congenital, Hearing Loss, Neurodevelopmental Disorders, Immunogenicity
- Trial name
- NCT03722615
- Where
- South Africa
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
HIV Infections
Voluntary HIV Counseling, Testing, and Medication for Pregnant Women to Prevent Mother-to-Child HIV Transmission
Voluntary HIV counseling and testing (VCT) and anti-HIV drugs for pregnant women and their newborns decrease rates of mother-to-child transmission (MTCT) of HIV.
- Trial name
- NCT00084045
- Testing
- Intrapartum HIV counseling/testing, Postpartum HIV counseling/testing
- Where
- 2 sites in South Africa
- Volunteers
- 283 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Perinatal HIV Infection
Boosting the HRQoL Among HIV+ Mothers and Children
The goal of this randomized controlled trial is to test the effectiveness of a resilience intervention and an adherence intervention in improving health-related quality of life (HRQoL) among perinatally infected HIV positive…
- Trial name
- NCT06340698
- Testing
- Resilience intervention, Adherence intervention
- Where
- China
- Volunteers
- 130 people
- Sponsor
- City University of Hong Kong
HIV Infections
Development of Resistance Mutations in Pregnant HIV-positive (+) Women Following Perinatal Antiretroviral Therapy in Israel
It has been shown that treatment of HIV-positive women with antiretroviral medication during pregnancy reduces the risk of HIV transmission to the child.
- Trial name
- NCT00197366
- Where
- 5 sites in Israel
- Volunteers
- 50 people
- Sponsor
- Hadassah Medical Organization
Infant, Newborn, Diseases, Sepsis
Prevention of Perinatal Sepsis (PoPS): Evaluation of Chlorhexidine Wipes of Birth Canal and Newborn
The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth.
- Conditions
- Infant, Newborn, Diseases, Sepsis, Puerperal Infection
- Trial name
- NCT00136370
- Testing
- Chlorhexidine, Birth canal wipe, sterile water external genital wipe
- Where
- South Africa
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
HIV/AIDS, Infant Morbidity
Impact of Point-of-Care EID for HIV-Exposed Infants
This mixed methods study will utilize a randomized step-wedge design to assess the impact of point-of-care (POC) versus conventional early infant diagnosis (EID) on key outcomes including timely return of results to caregivers…
- Conditions
- HIV/AIDS, Infant Morbidity, Pediatric HIV Infection, Transmission, Perinatal Infection
- Trial name
- POC-EID (NCT03824067)
- Testing
- Point of Care Early Infant Diagnosis, Standard of Care Early Infant Diagnosis
- Where
- 2 sites in Kenya, Zimbabwe
- Volunteers
- 9,539 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
HIV Infections, Pregnancy Complications, Infectious
Prenatal and Postnatal Studies of Interventions for Prevention of Mother-To-Child Transmission
The purpose of this study is to collect and study clinical and laboratory information about a pregnant or new mother and her medical care that will increase our knowledge of the best care for HIV-infected pregnant women and their…
- Trial name
- NCT00028145
- Testing
- Adherence assessment
- Where
- 77 sites in United States, Puerto Rico
- Volunteers
- 3,090 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group