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
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
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, 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
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
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
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
Hiv, Sexually Transmitted Infections (Not HIV or Hepatitis)
Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model
The investigators will conduct a 3-arm individual-level RCT in Kisumu and Siaya, Kenya to compare perinatal outcomes associated with 3 models of STI testing and management in antenatal care.
- Trial name
- PrIMI (NCT06203951)
- Testing
- Xpert® CT/NG and TV testing
- Where
- 8 sites in Kenya
- Volunteers
- 3,132 people, healthy volunteers welcome
- Sponsor
- University of Washington
HIV/AIDS, Infant Morbidity
Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe
This study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings.
- Conditions
- HIV/AIDS, Infant Morbidity, Perinatal HIV Infection, HIV Infections
- Trial name
- NCT04206241
- Testing
- Point of care early infant diagnosis (POC EID)
- Where
- 10 sites in Zimbabwe
- Volunteers
- 278,833 people, healthy volunteers welcome
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
HIV-1
Interventions to Decrease the Risk of Mother-to-Child Transmission of HIV in India
This study, conducted in Tamil Nadu, India, was initiated in response to the developing epidemic of HIV/AIDS in India. It is divided into two stages, as follows: Stage I All women registered in the pregnancy clinics at the…
- Trial name
- NCT00341796
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
HIV/AIDS
Neuropsychological Outcomes of Internationally-Adopted Children Who Are Perinatally-Infected With Human Immunodeficiency Virus
Children who are perinatally-infected with HIV are extremely vulnerable to cognitive delays and psychiatric disease, and the risk for neuropsychiatric illness is compounded in children who are internationally-adopted and may have…
- Trial name
- NCT03100331
- Testing
- Neuropsychological testing
- Volunteers
- 17 people
- Sponsor
- Corewell Health West
Hiv
Prospective Cohort Study of Adolescents Living With HIV and Their Caregivers Attending a Psychosocial Programme in Botswana
Adolescents/young adults with perinatally acquired HIV (PAH) face a number of antiretroviral (ART) adherence and well-being challenges.
- Trial name
- NCT03571555
- Testing
- Sentebale Psychosocial Programme
- Where
- Botswana
- Volunteers
- 516 people
- Sponsor
- Royal Holloway University
HIV Infections
Safety & Immunogenicity of 426c.Mod.Core-C4b Vaccine With 3M-052-AF+Alum in Infants Perinatally Exposed to HIV But Uninfected
The purpose of this study is to evaluate the safety and immunogenicity of 426c.Mod.Core-C4b vaccine adjuvanted with 3M-052-AF + Alum in infants with perinatal HIV exposure who are without HIV at birth
- Trial name
- HVTN316 (NCT06613789)
- Testing
- 426c.Mod.Core-C4b, 3M-052-AF, Aluminum hydroxide suspension (Alum)
- Where
- South Africa
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- HIV Vaccine Trials Network