Clinical trials: Perinatal HIV Infection
HIV Infections
Evaluating Strategies to Reduce Mother-to-Child Transmission of HIV Infection in Resource-Limited Countries
The purpose of this study was to examine, in an integrated and comprehensive fashion, three critical questions currently facing HIV-infected pregnant and postpartum women and their infants: 1.
- Trial name
- PROMISE (NCT01061151)
- Testing
- Zidovudine (ZDV), Nevirapine (NVP): Antepartum Mothers, Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail
- Where
- 14 sites in India, Malawi and 5 more
- Volunteers
- 3,747 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections, Pregnancy
Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated With Zidovudine
To identify patterns of zidovudine ( AZT ) susceptibility among mother/infant pairs with perinatal HIV transmission. Most HIV-infected infants acquire their disease via perinatal transmission.
- Trial name
- NCT00000828
- Where
- 29 sites in United States, Puerto Rico
- Volunteers
- 250 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Immunology of the Infection Perinatal
ANRS-EP38-IMMIP is a non interventional study. A single blood sample (30 mL) was drawn during a hospital visit for clinical follow-up. Immunological assays were performed on fresh blood.
- Trial name
- EP38 (NCT01055873)
- Testing
- A single blood sample (30 mL)
- Volunteers
- 93 people
- Sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
HIV Infections
Comparison of Anti-HIV Drug Combinations to Prevent Mother-to-Child Transmission of HIV
Pregnant women infected with HIV who take anti-HIV medications during pregnancy lower the risk of passing HIV to their infants. This study will compare how well two different combinations of anti-HIV medications control HIV in…
- Trial name
- NCT00086359
- Testing
- Abacavir sulfate, lamivudine, and zidovudine, Lamivudine/zidovudine, Lopinavir/ritonavir
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 19 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV, Pregnancy
Evaluating HITSystem 2.1 to Improve Viral Suppression in Kenya
The goal of this project is to rigorously evaluate the efficacy of HIV Infant Tracking System 2.1 (HITSystem, an eHealth intervention that uses short message service (SMS) texts to patients and algorithm-driven electronic alerts…
- Trial name
- NCT04571684
- Testing
- HITSystem 2.1
- Where
- 12 sites in Kenya
- Volunteers
- 1,639 people
- Sponsor
- University of Kansas Medical Center
HIV, Depression
Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi
The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with…
- Conditions
- HIV, Depression, Depression, Postpartum
- Trial name
- NCT06702722
- Testing
- Enhanced Friendship Bench, Enhanced usual care
- Where
- 5 sites in Malawi
- Volunteers
- 400 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV Infections, Pregnancy
Maternal/Infant Peripartum NVP, Versus Infant Only Peripartum NVP, or Maternal LPV/r in Addition to Standard ZDV Prophylaxis for the Prevention of Perinatal (PMTCT) HIV in Thailand
The purpose of this study is to compare the efficacy of two doses of nevirapine (NVP) given only to the infants or lopinavir/ritonavir (LPV/r) from 28 weeks gestation with single dose (SD) NVP given to the mothers plus two doses…
- Trial name
- PHPT-5 (NCT00409591)
- Testing
- Maternal and infant nevirapine, Maternal lopinavir+ritonavir, zidovudine
- Where
- 43 sites in Thailand
- Volunteers
- 435 people
- Sponsor
- Institut de Recherche pour le Developpement
Perinatal Depression, HIV-1-infection
A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
This pilot study will evaluate, through quantitative and qualitative methods, whether different treatments for postpartum depression are feasible and acceptable in postpartum HIV infected women on antiretrovirals (ART).
- Trial name
- NCT04094870
- Testing
- Sertraline, Interpersonal therapy
- Where
- 2 sites in Zambia
- Volunteers
- 80 people
- Sponsor
- University of North Carolina, Chapel Hill
Human Immunodeficiency Virus, Perinatal Depression
Adaptation of the Friendship Bench Intervention for HIV-infected Perinatal Women in Lilongwe
In many sub-Saharan African countries, the scale-up of lifelong antiretroviral treatment (ART) to all pregnant and breastfeeding women under Option B+ has the potential to radically improve maternal health and reduce…
- Trial name
- Periscope (NCT04143009)
- Testing
- Enhanced Friendship Bench, Enhanced Standard Care (Control), Adapted Friendship Bench
- Where
- 3 sites in Malawi
- Volunteers
- 92 people
- Sponsor
- University of North Carolina, Chapel Hill
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 Infection
Zambia Exclusive Breastfeeding Study
The study is designed as a randomized, controlled trial with specific observational objectives. All HIV-seropositive pregnant subjects electing to breastfeed their child will be counselled to exclusively breastfeed through 4…
- Trial name
- NCT00310726
- Testing
- abrupt weaning at 4 months, Continued exclusive breastfeeding
- Where
- Zambia
- Volunteers
- 1,435 people
- Sponsor
- Boston Medical Center
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
HIV/AIDS
Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite
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 as they transition to adulthood.
- Trial name
- AMP Up Lite (NCT03279185)
- Where
- 9 sites in United States
- Volunteers
- 334 people
- Sponsor
- Harvard School of Public Health (HSPH)
Depression
Healthy Options: Group Psychotherapy for HIV-positive Depressed Perinatal Women.
Although there is a significant burden of depression among HIV-positive women in Tanzania, there is a critical gap between the needs of this population and the integration of mental health and PMTCT-plus services.
- Trial name
- NCT02039973
- Testing
- Task-sharing approach to group therapy, Enhanced standard of care
- Where
- Tanzania
- Volunteers
- 742 people
- Sponsor
- Harvard Medical School (HMS and HSDM)
Perinatal HIV Infection, Cardiac Fibrosis
Immune Correlates of Cardiac Structure and Function
The purpose of this study is to determine the occurrence of scarring of the heart (cardiac fibrosis) and inflammation in those with perinatally acquired Human Immunodeficiency Virus (HIV) infection compared to people not infected…
- Conditions
- Perinatal HIV Infection, Cardiac Fibrosis, Cardiac Inflammation
- Trial name
- NCT05328713
- Testing
- Cardiac MRI
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Duke University
HIV Infections
Safety and Blood Levels of Tenofovir Disoproxil Fumarate in HIV Infected Pregnant Women and Their Babies
To prevent mother-to-child transmission (MTCT) of HIV in resource-limited countries, a simple yet effective treatment plan is needed.
- Trial name
- NCT00120471
- Testing
- Tenofovir disoproxil fumarate
- Where
- 5 sites in Brazil, Malawi
- Volunteers
- 122 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV Infections
Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth
The purpose of this study is to compare the effects of anti-HIV drug courses of different lengths in infants who became HIV infected at birth.
- Trial name
- NCT00102960
- Testing
- Abacavir sulfate, Didanosine, Efavirenz
- Volunteers
- 377 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)