Clinical trials: Children Exposed to HIV
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
Pre-exposure Prophylaxis, HIV Prevention
UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC/TDF or 3TC/TDF) for the prevention of HIV during pregnancy and breastfeeding…
- Conditions
- Pre-exposure Prophylaxis, HIV Prevention, Pregnancy Related
- Trial name
- PrIMO (NCT06158126)
- Testing
- Initiating daily oral PrEP during pregnancy, Already using daily oral PrEP at the time of pregnancy diagnosis, Initiating injectable PrEP during pregnancy
- Where
- Malawi
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
Hiv
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily…
- Trial name
- SCOPE-PP (NCT05322629)
- Testing
- PrEP adherence biofeedback, Standard of care counseling
- Where
- South Africa
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- University of California, Los Angeles
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
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
Neurodevelpmental Delays, Neurodevelopment
Implementation Outcomes and Cost-effectiveness of Developmental Monitoring for Children Exposed to HIV
The goal of this study is to learn about how to best carry out neurodevelopmental screening methods (tests to see if a young child can use support with brain development) in routine clinic visits in Botswana and Kenya among…
- Conditions
- Neurodevelpmental Delays, Neurodevelopment, Neurodevelopment Outcome
- Trial name
- IMPLEMENT (NCT07457411)
- Testing
- Neurodevelopmental screening
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- University of Washington
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
HIV Infections, Pregnancy
A Study of Zidovudine in HIV-Infected Pregnant Women and Their Children
AMENDED: To evaluate the pharmacokinetics of intravenously administered AZT to HIV-1 infected pregnant women in labor; to evaluate the pharmacokinetics and urinary excretion of AZT and its metabolites in newborns of HIV-1…
- Trial name
- NCT00001106
- Testing
- Zidovudine
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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)
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)
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)
HIV Infections
Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
To evaluate the single dose pharmacokinetic profile of Viracept pediatric powder formulation administered to HIV infected or exposed children and infants (0 to 13 years of age).
- Trial name
- NCT00002164
- Testing
- Nelfinavir mesylate
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Agouron Pharmaceuticals
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
Mother to Child HIV Transmission
HIV Diagnosis and Treatment at Birth for Newborn With High Risk HIV Exposure
Principal objective Assess the operational efficacy of a strategy combining early diagnosis and preventive antiretroviral treatment systematically reinforced from the birth* among infants at high risk of infection with HIV** .
- Trial name
- DIAVINA (NCT03642704)
- Testing
- Reinforced preventive ARV therapy
- Where
- Guinea
- Volunteers
- 56 people
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV Infections, Pneumococcal Infections
Safety of and Immune Response to a Pneumococcal Vaccine (PncCV) in HIV Infected and Uninfected Children
Infection by Streptococcal pneumoniae is a common invasive bacterial infection in HIV infected children. The purpose of this study is to determine the safety of and immune response to a pneumococcal polysaccharide-protein…
- Trial name
- NCT00099658
- Testing
- Pneumococcal polysaccharide-protein conjugate vaccine
- Volunteers
- 579 people, healthy volunteers welcome
- Sponsor
- CIPRA SA
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