Clinical trials: Pregnancy; Parasitic Disease
Malaria
Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali
Background: Malaria is a disease spread by mosquitos. Pregnant women are highly susceptible to malaria. This can lead to poor health outcomes for pregnant women and their babies.
- Trial name
- NCT03989102
- Testing
- PfSPZ Vaccine, Normal Saline
- Where
- Mali
- Volunteers
- 324 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Trichomonas Infection
A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis
This is a Phase 3, multi-center, prospective, randomized, placebo-controlled, delayed treatment, double-blind, study to evaluate the effectiveness, and safety of a single, oral dose of Solosec® containing 2 grams of secnidazole…
- Trial name
- NCT03935217
- Testing
- Secnidazole
- Where
- 11 sites in United States
- Volunteers
- 147 people
- Sponsor
- Lupin Research Inc
Malaria, HIV Infections
Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women
This study is an open-label, single site, randomized controlled trial comparing protease inhibitor (PI)-based antiretroviral therapy (ART) to non-PI based ART for HIV-infected pregnant and breastfeeding women of all CD4 cell…
- Trial name
- PROMOTE-PIs (NCT00993031)
- Testing
- Lopinavir/ritonavir, Efavirenz, Zidovudine
- Where
- Uganda
- Volunteers
- 389 people
- Sponsor
- University of California, San Francisco
Vaginitis, Infectious Vaginosis
A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
The purpose of this comparative study is to evaluate the efficacy of an ovule with triple active agents (terconazole, clindamycin and fluocinolone) versus another ovule with triple active agents (nystatin, metronidazole and…
- Trial name
- NCT01867164
- Testing
- Gynoclin V, Vagitrol V
- Where
- 2 sites in Mexico
- Volunteers
- 160 people
- Sponsor
- Janssen-Cilag, S.A.
Malaria
Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda
This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) + dihydroartemisin-piperaquine (DP) will significantly reduce the risk of adverse birth outcomes…
- Trial name
- NCT04336189
- Testing
- Sulfadoxine-pyrimethamine (SP), Dihydroartemisinin-piperaquine (DP)
- Where
- Uganda
- Volunteers
- 2,757 people, healthy volunteers welcome
- Sponsor
- Grant Dorsey, M.D, Ph.D.
Malaria
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
This will be a double-blinded randomized controlled phase III trial of 782 HIV uninfected pregnant women and the children born to them.
- Trial name
- PROMOTE-BC3 (NCT02793622)
- Testing
- Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy, Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy
- Where
- Uganda
- Volunteers
- 782 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Schistosomiasis
S. Japonicum and Pregnancy Outcomes
The purpose of the study is to understand whether the drug praziquantel (PZQ) is safe for the mother and developing baby when the mother has schistosomiasis (a type of worm) infection, and whether the drug may improve the…
- Trial name
- NCT00486863
- Testing
- Praziquantel
- Where
- Philippines
- Volunteers
- 370 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Vaginitis Trichomonal or Due to Trichomonas
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women
The overall goal of this project is to determine the influence of patient treatment and host factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women
- Trial name
- NCT01832480
- Testing
- MTZ 500 mg twice daily x 7 days, MTZ 2 g
- Where
- 3 sites in United States
- Volunteers
- 623 people
- Sponsor
- Tulane University Health Sciences Center
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
Bacterial Vaginosis, Candidiasis
Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
This research study is about vaginal infections such as bacterial vaginosis, yeast infections, and trichomoniasis. Usually, these infections can be treated with medication, but sometimes they come back after treatment.
- Conditions
- Bacterial Vaginosis, Candidiasis, Trichomoniasis
- Trial name
- NCT01230814
- Testing
- Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate)
- Where
- 4 sites in United States, Kenya
- Volunteers
- 234 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Trichomonas Vaginitis
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
The investigators are trying a combination vaginal product of higher dose metronidazole combined with miconazole to see if it is effective in treating vaginal trichomonas.
- Trial name
- NCT01361048
- Testing
- oral metronidazole, neo penotran forte, neo penotran forte once a day
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Alabama at Birmingham
Malaria
Reducing the Burden of Malaria in HIV-uninfected Pregnant Women and Infants
This will be a double-blinded randomized controlled phase III trial of 300 HIV uninfected pregnant women and the children born to them. The study interventions will be divided into two phases.
- Trial name
- PROMOTE-BC1 (NCT02163447)
- Testing
- Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, 3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy, 3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy
- Where
- Uganda
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Grant Dorsey, M.D, Ph.D.
Malaria
Chloroquine for Malaria in Pregnancy
The purpose of this study is to test prevention strategies for pregnancy-related malaria. Researchers will compare different malaria treatments and treatment schedules which include chloroquine therapy (weekly doses versus being…
- Trial name
- NCT01443130
- Testing
- Chloroquine, Sulfadoxine-pyrimethamine
- Where
- Malawi
- Volunteers
- 900 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Vaginitis, Bacterial Vaginosis
Point of Care Diagnosis of Vaginal Infections
Vaginal infections are a common gynecologic issue and may cause significant symptoms and discomfort for individuals. Point of care tests are used to diagnose infections in the office, with an advantage of quick diagnosis and…
- Conditions
- Vaginitis, Bacterial Vaginosis, Yeast Vaginitis, Trichomonas Vaginitis
- Trial name
- PAT (NCT06438575)
- Testing
- Xpert® Xpress MVP test, Usual Care
- Where
- United States
- Volunteers
- 351 people
- Sponsor
- Sharon L Hillier