Clinical trials: Mother-to-Child Transmission
Hepatitis B, Vertical Transmission of Infectious Disease
The COMBAT HBV Feasibility Trial
This is a double-blind, randomized placebo-controlled trial (RCT) of a prophylaxis-for-all approach to prevention of mother-to-child transmission (PMTCT) of hepatitis B virus (HBV) in the Democratic Republic of Congo (DRC).
- Trial name
- COMBAT-HBV (NCT05705427)
- Testing
- Tenofovir Disoproxil Fumarate 300 MG, Hepatitis B monovalent vaccine
- Where
- Democratic Republic of the Congo
- Volunteers
- 317 people
- Sponsor
- University of North Carolina, Chapel Hill
Dental Caries
Study on Use of Xylitol-wipes to Prevent Dental Caries
Mutans streptococci (MS) and lactobacillus species (LB) are the two groups of infectious cariogenic (caries-causing) bacteria most strongly associated with dental caries (dental decay).
- Trial name
- WIPE (NCT01468727)
- Testing
- xylitol wipe
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
HIV (Human Immunodeficiency Virus)
Safe Generations Plus: Swaziland PMTCT LTF Study
This study is to understand how to improve retention in care and treatment services to HIV positive pregnant women and their babies in Swaziland.
- Trial name
- SG+ (NCT02969161)
- Where
- 10 sites in Eswatini
- Volunteers
- 616 people
- Sponsor
- Columbia University
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
Caries, Dental
Prevention of Transmission of Bacteria That Cause Cavities From Mothers to Their Children
The purpose of this study is to control the levels of bacteria that causes cavities in mothers by a combination of treatments that include fluoride and chlorhexidine varnishes and xylitol-chewing gum before the appearance of…
- Trial name
- NCT00066040
- Testing
- Cervitec chlorhexidine varnish, Duraphat fluoride varnish, xylitol gum from Fennobon, Finland
- Where
- Brazil
- Volunteers
- 280 people
- Sponsor
- New York University
HIV Infections
Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents
Integrase is 1 of 3 HIV (Human Immunodeficiency Virus)-1 enzymes required for viral replication. Raltegravir is a drug that prevents integrase from working properly.
- Trial name
- NCT00485264
- Testing
- Raltegravir poloxamer film coated tablet, Raltegravir chewable tablet, Raltegravir oral granules for suspension (20 mg/mL)
- Where
- 42 sites in United States, Argentina and 4 more
- Volunteers
- 153 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
Texting to Improve Testing (TextIT):
Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in…
- Trial name
- TextIT (NCT02350140)
- Testing
- Text messaging from beginning, Text messaging after 6 months of control
- Where
- Kenya
- Volunteers
- 2,508 people
- Sponsor
- University of Washington
Mother-to-child HIV Transmission
The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV
The study design includes an observational prospective cohort of HIV-positive pregnant/postpartum women and their infants enrolled during antenatal clinics (or immediately postpartum) from prevention of mother-to-child…
- Trial name
- Kabeho (NCT02295800)
- Testing
- Standard of care, Semi-structured interviews
- Where
- Rwanda
- Volunteers
- 1,216 people
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
Vertical Disease Transmission, HBV
Hepatitis B Virus Vertical Transmission From HIV-HBV Co-infected Women
Vertical HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women.
- Trial name
- NCT02044068
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Hopital Lariboisière
HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus)
MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo
Performance study to evaluate the clinical performance of the In-Vitro Diagnostic Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and…
- Conditions
- HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus), Hepatitis C Virus (HCV), Syphilis
- Trial name
- MAGICS MAM (NCT07388979)
- Testing
- MAGIA H3S
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Gardiens de Vies
HIV Infections
Routine Use of Antiretroviral Therapy to Prevent Mother-to-Child HIV Transmission in the Kafue District of Zambia
The investigators will enroll a cohort of HIV-infected pregnant women accessing PMTCT services, to better understand the incremental benefits (e.g. reduction in HIV transmission, improvements in HIV-free survival) and risks (e.g.
- Trial name
- NCT00753324
- Testing
- Routine three-drug antiretroviral prophylaxis
- Where
- Zambia
- Volunteers
- 284 people
- Sponsor
- University of North Carolina, Chapel Hill
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
Obesity, Obesity, Childhood
In-home Obesity Prevention to Reach Low-income Infants
Existing obesity prevention efforts have had limited success among underserved, low-income children. This study capitalizes on the strengths of a nationwide ongoing Home Visitation Program (HVP), which serves at-risk, low-income…
- Conditions
- Obesity, Obesity, Childhood, Obesity; Familial
- Trial name
- NCT03529695
- Testing
- Standard HVP Curriculum, Obesity Prevention
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- University of Southern California
HIV/AIDS and Infections
Antiretroviral Regime for Viral Eradication in Newborns
This is a multi-center, randomized, controlled, open clinical trial. The trial will be carried out in five provinces in China. Pregnant women with HIV infection and at high risk of mother-to-child transmission of HIV will be…
- Trial name
- NCT02712801
- Testing
- Zidovudine, Nevirapine, Lamivudine
- Where
- 5 sites in China
- Volunteers
- 600 people
- Sponsor
- National Center for Women and Children's Health, China CDC
HIV Infections
Male Partner Involvement in the Prevention of MTCT of HIV
The study aims to invite male sexual partners to attend antenatal clinic with their pregnant partners to either acquire pregnancy information or undergo voluntary counselling and testing for HIV.
- Trial name
- NCT00405990
- Testing
- Voluntary counselling and HIV testing in ANC for PMTCT, VCT
- Where
- South Africa
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Imperial College London
HIV Infections, Syphilis Infection
Implementation of an Opt-Out Testing and Rapid Diagnostic Strategy for Syphilis and HIV in Pregnant Patients Presenting to the Emergency Department
The purpose of this study is to evaluate infection detection and treatment initiation rates for syphilis and HIV before and after integration of the Chembio DPP® HIV-Syphilis rapid POC test into an ongoing Emergency Department…
- Trial name
- NCT07525076
- Testing
- Chembio HIV/Syphilis rapid Point of Care (POC) test, Laboratory-based HIV and syphilis testing
- Where
- United States
- Volunteers
- 1,400 people
- Sponsor
- The University of Texas Health Science Center, Houston
HIV
Clinical Study of an Aluvia-based HAART Regimen for Prevention of Mother-to-child HIV Transmission in Africa
Therapeutic options to prevent vertical transmission of HIV remain limited. Combination antiretroviral therapy in the form of HAART (Highly Active Anti Retroviral Therapy) is generally recommended in the developed world, both for…
- Trial name
- NCT01088516
- Testing
- Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TC
- Where
- Zambia
- Volunteers
- 280 people
- Sponsor
- University of Zambia
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, Pregnancy Related
DTG Plus 3TC for Prophylaxis of Mother-to-child Transmission of HIV Infection in Pregnant Women
The study aims to evaluate the safety and efficacy of a 2 drugs ART regimen (lamivudine plus dolutegravir) for prevention of mother to child transmission in pregnant women with HIV.
- Conditions
- HIV Infections, Pregnancy Related, Mother to Child Transmission
- Trial name
- PREGNANCY (NCT04808973)
- Testing
- Dolutegravir plus lamivudine in a FDC
- Where
- Brazil
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fundação Bahiana de Infectologia
Hepatitis B, Tenofovir
Tenofovir in Pregnancy to Prevent Mother to Child Transmission of Hepatitis B.
Hepatitis B virus (HBV) can be asymptomatic for years but can also lead to chronic hepatitis, hepatocellular carcinoma, and liver failure and death and cannot be eradicated with the current therapy.
- Conditions
- Hepatitis B, Tenofovir, Pregnancy
- Trial name
- PK-TDF (NCT04114890)
- Testing
- Tenofovir Disoproxil Fumarate
- Where
- Thailand
- Volunteers
- 27 people
- Sponsor
- University of Oxford