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, 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
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)
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)
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, 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 Infections
Feasibility and Pilot Efficacy of Flash-heated Breast Milk to Reduce Maternal-to-Child-Transmission of HIV in Tanzania
This study will investigate the feasibility of HIV positive mothers in Tanzania to correctly use the Flash-heat method to pasteurize their breast milk and for how long they are able to do so.
- Trial name
- Flash-heat (NCT00523510)
- Testing
- Infant feeding counseling that includes Flash-heat
- Where
- United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
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/AIDS
Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as they transition into adulthood.
- Trial name
- AMP Up (NCT02119702)
- Where
- 14 sites in United States, Puerto Rico
- Volunteers
- 818 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
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
HIV Infections
Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission
The purpose of this study is to see if antibiotic drugs given to treat an infection of the uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive mother to her baby.
- Trial name
- NCT00021671
- Testing
- Erythromycin, Nevirapine, Ampicillin sodium
- Where
- United States
- Volunteers
- 3,720 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Effects of Maternal Anti-HIV Treatment on Infants Born to HIV-Infected Women
In clinical trials being conducted throughout the world, pregnant HIV-infected women are given anti-HIV drugs before, during, and after they give birth to prevent mother-to-child transmission of HIV.
- Trial name
- NCT00100867
- Where
- 23 sites in Botswana, Brazil and 6 more
- Volunteers
- 236 people, healthy volunteers welcome
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Consent Form
Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research
This study evaluates a visual Informed Consent Form (ICF) compared to a standard, text-only ICF as an approach to achieving meaningful consent into a clinical trial.
- Trial name
- NCT07122960
- Testing
- Visual ICF, Text-only ICF
- Where
- South Africa
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Columbia University
Antiretroviral Toxicity
Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women
SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers.
- Trial name
- SMARTT (NCT01310023)
- Where
- 22 sites in United States, Puerto Rico
- Volunteers
- 5,169 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
HIV Infection, Tuberculosis
Daily Isoniazid to Prevent Tuberculosis in Infants Born to Mothers With HIV
Tuberculosis (TB) is highly endemic in sub-Saharan Africa. The increased burden of TB in settings with high prevalence of the Human Immunodeficiency Virus (HIV) is associated with high rates of transmission of Mycobacterium…
- Conditions
- HIV Infection, Tuberculosis, Pneumocystis Jiroveci Pneumonia
- Trial name
- NCT00080119
- Testing
- Isoniazid (INH), Trimethoprim/Sulfamethoxazole (TMP/SMX)
- Where
- 6 sites in Botswana, South Africa
- Volunteers
- 1,354 people, healthy volunteers welcome
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
HIV Infections
Getting to Zero: Safer Conception Programming Among HIV Sero-different Couples in Uganda
Despite effective strategies to reduce periconception HIV transmission, there are few services to support people living with or affected by HIV to use these methods.
- Trial name
- G2Z (NCT03895619)
- Testing
- Safer conception strategies
- Where
- Uganda
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Simon Fraser University