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NCT ID: NCT02448615 Completed - Child Development Clinical Trials

Birth Cohort in Coast Province, Kenya

Start date: July 2015
Phase: N/A
Study type: Observational

In 2010, 7.6 million children under the age of five died worldwide and yet the causes of only 2.7% (0.205 million) of these deaths were medically certified. A thorough understanding of the causes of child mortality is necessary to guide research efforts aimed at tackling this important global health problem. Prospective birth cohort studies present an opportunity to examine the relationships between early-life exposures and multiple health and non-health related outcomes including death, illness, and socioeconomic factors. In this study, the investigators will provide insight into the underlying causes of child mortality by collecting data on early-life exposures and health and non-health related outcomes in the first year of life.

NCT ID: NCT02445989 Completed - HIV Clinical Trials

Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity

Start date: May 2016
Phase: Phase 4
Study type: Interventional

The investigators propose to explore the hypothesis—supported by limited data—that a contraceptive vaginal ring (CVR) that is commonly used in the United States, the NuvaRing, will enhance women's genital and reproductive health. The investigators propose that this CVR will increase the bacteria that help the vaginal environment protect against infection by HIV and other STIs, and that in women who already have HIV, use of the CVR will lower the quantity of HIV that is shed in the female genital tract.

NCT ID: NCT02434770 Completed - Poliomyelitis Clinical Trials

Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine

Start date: August 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV) manufactured by Beijing Bio-Institute Biological Products Co., Ltd (BBIBP) has a similar immunogenicity profile to a WHO prequalified bOPV.

NCT ID: NCT02431143 Completed - Clinical trials for Visceral Leishmaniasis

Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa

Start date: May 2015
Phase: Phase 2
Study type: Interventional

This is a multicenter, non-comparative, open-label clinical trial to assess the Pharmacokinetics (PK) and safety of miltefosine using an allometric dose algorithm in the treatment of children with primary Visceral Leishmaniasis (VL) in eastern Africa. Efficacy and Pharmacodynamics (PD) will be assessed as secondary outcomes. The proposed study aims to assess whether drug exposure in children can be increased to equivalent adult drug exposure by using the miltefosine allometric dose given BID for 28 days in paediatric VL patients aged 4-12y and whether this dose is tolerable. The present study is also expected to provide the basis for minimum time to reach sufficient drug exposure for miltefosine activity to guide optimal treatment duration to be used in combination therapy for visceral leishmaniasis. The PK data will be assessed in this trial using a compartmental population PK approach.

NCT ID: NCT02430506 Completed - Tuberculosis Clinical Trials

A Study to Evaluate Safety and Immunogenicity of AERAS-402 Administered in HIV-negative, BCG-vaccinated, QFT (+) and (-) Adults Without Evidence of TB

C-012-402
Start date: September 2008
Phase: Phase 1
Study type: Interventional

The available live tuberculosis vaccine Bacillus Calmette-Guérin (BCG) provides incomplete protection against pulmonary tuberculosis. For unknown reasons, a BCG revaccination or "booster", while not toxic, does not provide much additional protection. AERAS-402 presents tuberculosis antigens in the setting of a new, live, replication deficient adenovirus vaccine that may increase T cell immunity and thus protection from tuberculosis. Since BCG-vaccinated individuals are the population for which AERAS-402 might be indicated, AERAS-402 will be administered to individuals in Kenya who have already been vaccinated with BCG.

NCT ID: NCT02427945 Completed - Child Malnutrition Clinical Trials

Leveraging an Existing Large-scale Safe Water Program to Deliver Nutrition Messages at a Low Marginal Cost

Start date: May 2015
Phase: N/A
Study type: Interventional

The investigators are seeking to overcome the dual challenges of under-nutrition and diarrhea using an existing safe water supply platform to deliver nutrition information to targeted groups in Western Kenya. Using a randomized evaluation, investigators will determine the impact on nutrition status and practices of delivering nutrition information. The evaluation results will enable Evidence Action to make strategic decisions regarding the potential scale-up of the combined program across Kenya.

NCT ID: NCT02412436 Completed - Tuberculosis Clinical Trials

PK Study of Rifampicin Interactions With DMPA and Efavirenz in TB

PRIDE-HT
Start date: November 3, 2015
Phase: Phase 2
Study type: Interventional

This study was done to evaluate the effect of HIV and TB treatment on a commonly used birth control method. It enrolled women who were infected with HIV and TB and were taking efavirenz (EFV; Sustiva®; an anti-HIV medication), rifampicin (RIF; an anti-TB medication), and isoniazid (INH; an anti-TB medication). The purpose of this study was to find out the best frequency to give depot medroxyprogesterone acetate (DMPA; a hormonal birth control method that is given as a shot every 3 months) in these women. This study also tried to find out if a 150 mg injection of DMPA was effective in preventing ovulation, the process by which the ovaries (the ovaries are part of the female reproductive system) release an egg for fertilization, for 12 weeks in women who are taking EFV and RIF. Another purpose of this study was to find out if it is safe to take RIF, EFV and DMPA at the same time.

NCT ID: NCT02411994 Completed - Malaria Clinical Trials

Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Malaria

PAAL
Start date: October 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy of pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children.

NCT ID: NCT02410772 Completed - Tuberculosis Clinical Trials

TBTC Study 31: Rifapentine-containing Tuberculosis Treatment Shortening Regimens

S31/A5349
Start date: January 25, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether one or two four-month regimens of tuberculosis treatment are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week, with direct observation of each dose by a health-care worker at least five of the seven days of each week. The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide followed by four months of isoniazid and rifampin. The first short regimen is a single substitution of rifapentine for rifampin: two months of isoniazid, rifapentine, ethambutol, and pyrazinamide, followed by two months of isoniazid and rifapentine. The second short regimen is a double substitution of rifapentine for rifampin and moxifloxacin for ethambutol: two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid, rifapentine, and moxifloxacin. Target enrollment is 2500 participants. Each study participant will remain in the study for 18 months in order to include at least 12 months of evaluation of whether the participant's TB recurs.

NCT ID: NCT02409680 Completed - Premature Birth Clinical Trials

Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)

ASPIRIN
Start date: March 23, 2016
Phase: N/A
Study type: Interventional

Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth. However, this possibility needs to be proven in a properly designed randomized controlled trial (RCT) with preterm birth as the primary outcome. Such a clinical trial in a racially, ethnically and geographically diverse population could best be accomplished by the established infrastructure of the Global Network for Women's and Children's Health Research (GN).