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NCT ID: NCT03208231 Completed - HIV Infections Clinical Trials

Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy

Start date: August 6, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study was to evaluate the safety and antiviral activity to promote clearance of HIV-1 infected cells of VRC01 in infants with HIV beginning combination antiretroviral therapy (cART).

NCT ID: NCT03208179 Completed - Pregnancy Clinical Trials

Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa

IMPROVE
Start date: March 29, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates the efficacy and safety of monthly intermittent preventive treatment using dihydroartemisinin piperaquine (DP) alone or in combination with azithromycin (AZ) compared to sulphadoxine-pyrimethamine (SP) for the prevention of malaria in pregnant women in the second and third trimester.

NCT ID: NCT03206125 Terminated - Clinical trials for Esophageal Squamous Cell Carcinoma

NCI UNC Project ESCC

Start date: August 1, 2017
Phase:
Study type: Observational

Background: Esophageal cancer is a common cause of cancer deaths. Most cases of this cancer are esophageal squamous cell carcinoma (ESCC). Many of these cases come from two parts of the world with high-risk. One of these is in East Africa and include the country of Malawi. Researchers want to learn what factors explain the high risk there so we can understand better what causes this cancer in people everywhere. Objective: To learn more about causes and outcomes of esophageal squamous cell carcinoma using Malawi because of the large number of cases in that country. Eligibility: Adults at least 18 years old who have ESCC and live in a certain region of Malawi Adults in the same age group and location who do not have ESCC Design: Participants will be screened at a hospital in Malawi. Participants will have a 1-hour interview. They will answer questions about: Demographics (age, ethnicity, education) Place of residence Medical history and family medical history Drug, alcohol, and tobacco use Hot beverage consumption Indoor air pollution Occupation Food habits Farming Gastrointestinal health Participants will have their teeth and fingernails examined. Participants will be asked to give samples of blood, urine, saliva, toenails, and for the cancer cases, a small piece of their tumor. Participants will have 4 phone calls a year for 2 years to ask about their health....

NCT ID: NCT03201510 Completed - HIV Clinical Trials

Feasibility of HIV Prevention Cohort Studies Among Men Who Have Sex With Men in Sub-Saharan Africa

Start date: June 12, 2015
Phase:
Study type: Observational

This study aims to determine the feasibility of recruiting and retaining men who have sex with men (MSM) in a multi-country prospective cohort study in preparation for human immunodeficiency virus (HIV) prevention studies in sub-Saharan Africa (SSA).

NCT ID: NCT03164564 Active, not recruiting - HIV Infections Clinical Trials

Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women

Start date: November 7, 2017
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in HIV-uninfected women.

NCT ID: NCT03160209 Completed - Clinical trials for Esophageal Squamous Cell Carcinoma

HIV and Other Risk Factors for Esophageal Squamous Cell Carcinoma in Malawi

Start date: July 26, 2017
Phase:
Study type: Observational

The primary purpose of this single-center, case-control, non-interventional study is to determine risk factors which contribute to the development of esophageal squamous cell carcinoma (ESCC) at Kamuzu Central Hospital (KCH) and St. Gabriel Hospital (SGH) in Malawi.

NCT ID: NCT03160183 Completed - HIV Clinical Trials

Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi

Start date: September 2016
Phase:
Study type: Observational

The purpose of this study is to identify important associations between complete and comprehensive clinical, laboratory, and genomic data derived from patients and tumor specimens, with prospectively recorded clinical outcomes. The investigators also hope to move beyond simple risk factor associations as previously described, to develop a composite score specifically for KS recurrence or progression, analogous to widely used risk scores that are used to direct up-front treatment of other cancers. In so doing, the investigators will draw on extremely granular data to prospectively identify patients who are most likely to benefit from new treatments.

NCT ID: NCT03153709 Completed - HIV Infections Clinical Trials

Prospective Cohort Evaluating Pregnancy Rates, PK Interactions Among HIV+ Women on EFV Initiating LNG Implant or DMPA

FP-ART
Start date: August 17, 2017
Phase:
Study type: Observational

The purpose of this study is to compare the pregnancy rates among women who are using the HIV drug Efavirenz and either the birth control injection or implant.

NCT ID: NCT03136393 Completed - Clinical trials for Maternal Exposure During Pregnancy

Effect of Dietary Counseling During Pregnancy on Infant Birthweight in Mangochi , Malawi

Start date: November 1, 2015
Phase: N/A
Study type: Interventional

High neonatal mortality rates accounts for a substantial early loss of lives in Malawi; and has thus been a hindrance for Malawi to eradicate child deaths. From 2000 to 2011, Malawi achieved an overall reduction of 23% in under-five child mortality. The reduction was more substantial between the second and the fifth year of life, being 28%. However, in the neonatal period the reduction was half, at 14%. Neonatal deaths in developing countries are due to prematurity or low birth weight, neonatal infections, birth trauma related conditions and congenital anomalies. Being of low birth weight increases the risk of death four fold in the neonatal period. Even when low birth weight infants survive, their poorly developed immune function exposes them to increased morbidity in early life. Maternal nutrition represents by far the greatest influence among pregnancy environmental on birth weight in low income countries. There is strong evidence that health and dietary counselling is effective in improving child nutrition outcomes. Thus we propose to test the effectiveness in improving birth weight by a low cost intervention, community based health and nutrition counselling delivered to mothers during pregnancy in Malawi. On the other hand, in the Malawian context offering individualized dietetic counselling could be impeded by the healthcare workforce short fall. Currently the health workforce does not include dieticians . The use of lay health workers (LHW) has been identified as one of the effective strategies to meet the health workforce shortage challenges in low resource settings. It is on this basis that a study was planned, aimed at developing lay health worker delivered community based nutrition counselling to mothers during pregnancy and measuring its effectiveness in improving birth weight in the Malawian context. The study was comprised of an initial i) formative study, followed by ii) a cross-sectional survey. Findings of these two sub-studies were utilized to develop a nutrition counselling intervention. Finally iii) a cluster Randomized Controlled Trial (cRCT) aimed at measuring the effect of the intervention on birth size (weight, length, arm and abdominal circumferences) will now be conducted which is being elaborated in this protocol.

NCT ID: NCT03130114 Completed - Diarrhea Clinical Trials

Antibiotics for Children With Severe Diarrhoea

ABCD
Start date: May 13, 2017
Phase: Phase 3
Study type: Interventional

Although the current World Health Organization (WHO) recommended management package for acute diarrhoea (ORS, zinc and feeding advice) has contributed to significant reductions in diarrhoea associated mortality, over half a million children continue to die annually as a result of acute diarrhoeal episodes. In addition, rates of mortality in young children in the 90 days following an episode of acute diarrhoea appear at least as high as mortality that occurs during the acute episode. The long-term benefits of antibiotic administration may result from direct antimicrobial effects on pathogens or from other incompletely understood mechanisms including improved nutrition, alterations in immune tolerance or improved enteric function. Optimizing antibiotic treatment of acute diarrhoea episodes in very young children with severe disease may offer the opportunity to significantly reduce diarrhoea associated deaths in the 180 days following presentation for acute diarrhoea and may also improve growth. The investigators propose to evaluate the efficacy of an antibiotic (azithromycin) delivered in a specific, targeted fashion to young children (< 2 years of age) at high risk of diarrhoea associated mortality in a multi-site randomized, double-blind, placebo-controlled trial. The study will evaluate the ability of the intervention to reduce mortality within 180 days of the acute diarrhoeal episode, and improve nutritional status over the first 90 days.