Clinical trials: Children Exposed to HIV
Renal Injury
Impact of in Utero and Breastfeeding Exposure to Tenofovir on Renal Function in HIV-exposed Uninfected Children
The goal of this project is to determine whether and how in utero exposure to Tenofovir affects renal function in HIV-exposed uninfected infants
- Trial name
- NCT04070482
- Testing
- Tenofovir exposure in utero and during breastfeeding
- Where
- 3 sites in Cameroon
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of Yaounde 1
Infections, Streptococcal
Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.
The purposes of this study: To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants following a…
- Trial name
- NCT00829010
- Testing
- Pneumococcal vaccine GSK1024850A, Tritanrix-HepB/Hib, measles
- Where
- South Africa
- Volunteers
- 489 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
In Utero Drug Exposure
Cardiometabolic Health of Children Exposed to Anti-retroviral Therapy (ART) in Utero
The Human Immunodeficiency Virus (HIV) has been recently linked to increased risk for cardiovascular diseases (CVDs). The prevalence of cardiovascular diseases and its risk factor, hypertension, are very high in African…
- Trial name
- ARTMOMSBABES (NCT04763668)
- Testing
- Pregnant HIV positive women on ARTs, Babies born to HIV positive mothers on ARTs
- Where
- South Africa
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Walter Sisulu University
HIV Infections
Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding
The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and while breastfeeding.
- Trial name
- NCT01066858
- Testing
- Tenofovir disoproxil fumarate (TDF)
- Where
- 11 sites in Malawi, South Africa and 2 more
- Volunteers
- 1,765 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Heart Function in HIV-Negative Children Exposed to HIV and HAART
HIV-uninfected children born to HIV+ women have low level heart problems at birth which may predispose them to heart failure, arrythmias and heart attack later in life.
- Trial name
- NCT01107834
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Malnutrition in Children, Children Exposed to HIV
A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya
The goal of this study is to test if a two-way text-message (SMS) maternally administered malnutrition monitoring system (MAMMS) that delivers infant and young child feeding (IYCF) education and supports caregivers in monitoring…
- Trial name
- MAMMS IYCF R33 (NCT06842732)
- Testing
- Maternal Administered Malnutrition Monitoring System - Infant and Young Child Feeding (MAMMS IYCF) intervention, Standard of Care (SOC)
- Where
- 2 sites in Kenya
- Volunteers
- 776 people, healthy volunteers welcome
- Sponsor
- University of Washington
Child Development
Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving
Children exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort.
- Trial name
- ZICS-BOOST (NCT05119959)
- Testing
- ECD intervention for CHEUs, Usual care for CHEUs
- Where
- 2 sites in United States, Zambia
- Volunteers
- 469 people
- Sponsor
- Boston University
HIV/AIDS, HIV Infections
Treatment Options for Protease Inhibitor-exposed Children
The investigators hypothesize that switching to a regimen based on efavirenz will be as effective and safe as remaining on a regimen based on Lopinavir/ritonavir for HIV-infected children.
- Trial name
- NEVEREST-III (NCT01146873)
- Testing
- Efavirenz (EFV), Lopinavir/ritonavir (LPV/r), Stavudine (D4T)
- Where
- South Africa
- Volunteers
- 300 people
- Sponsor
- Columbia University
HIV Infections, Nutrition Poor
Supplementation Trial of KOKO Plus Among HIV Exposed Children in Accra
The overall aim of the research is to conduct a randomised controlled trial of KOKOPlus in young HIV exposed children attending HIV clinics in Accra, Ghana to test the effectiveness of KOKOPlus over a period of 6 months to…
- Conditions
- HIV Infections, Nutrition Poor, Child Development
- Trial name
- NCT04995874
- Testing
- KOKOPlus protein and micronutrient powder
- Where
- 6 sites in Ghana
- Volunteers
- 649 people, healthy volunteers welcome
- Sponsor
- Noguchi Memorial Institute for Medical Research
Hiv
Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)
The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the…
- Trial name
- PrEP-PP (NCT03826199)
- Testing
- TDF-FTC, Counselling on PrEP in antenatal and postnatal care
- Where
- South Africa
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
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)
Measles, Varicella
Safety and Immunogenicity of Measles Vaccine, Varicella Vaccine and Hepatitis-A Vaccine
This trial will evaluate the safety and immunogenicity of: i) measles vaccine (CAM-70) after primary dose at 6 months (MV1) and booster vaccination at 12 months (MV2); ii) a single dose of varicella vaccination at 18 months; and…
- Conditions
- Measles, Varicella, Hepatitis A
- Trial name
- MV/VV/Hep-AV (NCT03330171)
- Testing
- Measles vaccine, Hepatitis-A vaccine, Varicella vaccine
- Where
- South Africa
- Volunteers
- 278 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
Malaria, Human Immunodeficiency Virus
Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2)
This is a double-blinded, randomized controlled trial of 200 HIV-infected pregnant women living in Tororo, Uganda, an area of high malaria transmission.
- Trial name
- NCT02282293
- Testing
- Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS)
- Where
- Uganda
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Malaria
Impact of TMP-SMX Prophylaxis on Malaria Infection and Immunity in Children in Uganda
Background: Malaria is a disease that affects many children and adults in Uganda and Africa. If it is not treated, it can make some people severely ill.
- Trial name
- NCT02094508
- Where
- Uganda
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs
Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI).
- Trial name
- NCT00016718
- Testing
- Didanosine (ddI), Efavirenz (EFV), Emtricitabine (FTC)
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 43 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 Infection
Post-marketing Safety Surveillance Program in Human Immunodeficiency Virus (HIV)-Infected Children Exposed to Atazanavir in Europe
The purpose of this study is to monitor adverse events in HIV-infected children <18 years old who are exposed to Atazanavir in a real-world setting in Europe.
- Trial name
- NCT01389310
- Where
- 9 sites in Belgium, Germany and 5 more
- Volunteers
- 249 people
- Sponsor
- Bristol-Myers Squibb
Lack of; Care, Infant (Child), Malnutrition
Evaluation of an Infant Feeding Intervention for HIV-exposed Haitian Infants
The purpose of this quasi-experimental study is to evaluate the effectiveness of an infant feeding intervention in improving growth and anemia outcomes among HIV-exposed infants 6-12 months of age.
- Trial name
- NCT01434238
- Testing
- Counseling and nutrition supplement
- Where
- Haiti
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Cornell University
Pregnant HIV Positive Women
A Prospective, Observational Study of HIV-Infected Pregnant Women and Their Infants at Clinical Sites in Latin American and Caribbean Countries
By the end of 1999, it was estimated that 1.2 million children were living with HIV infection. During 1999 alone, 600,000 children were newly infected with HIV, mostly in less-developed countries.
- Trial name
- NCT00341302
- Where
- 12 sites in Argentina, Brazil and 1 more
- Volunteers
- 3,554 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pneumonia, Pneumocystis Carinii, HIV Infections
Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children
To determine the safety, tolerance, and pharmacokinetics of a new improved microparticulate suspension formulation of atovaquone administered at one of two dose levels (per 09/30/94 amendment, a third dose level was added) daily…
- Trial name
- NCT00000773
- Testing
- Atovaquone
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 24 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)