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NCT ID: NCT02342886 Completed - Clinical trials for Tuberculosis, Pulmonary, Multi Drug-resistant

Shortening Treatment by Advancing Novel Drugs

STAND
Start date: February 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB compared to standard HRZE treatment. This study will also assess the efficacy, safety and tolerability of a combination of moxifloxacin, PA-824, and pyrazinamide treatments after 6 months of treatment in subjects with multi drug-resistant (MDR) pulmonary TB compared to a combination of moxifloxacin, PA-824, and pyrazinamide treatments in DS-TB subjects.

NCT ID: NCT02341027 Completed - Lactation Clinical Trials

Immediate Versus Interval Postpartum Use of the Levonorgestrel Contraceptive Implants: a Randomized Controlled Trial

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

This study will evaluate if immediate postpartum placement of a levonorgestrel (LNG) contraceptive implant within 5 days of delivery improves implant utilization at 6 months postpartum compared to implant placement at 6-8 weeks postpartum among women in Uganda.

NCT ID: NCT02316444 Completed - Clinical trials for HIV/AIDS and Infections

Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda

Start date: November 2015
Phase: Phase 4
Study type: Interventional

The aim of this study is to compare the effectiveness of two vaccination strategies against Hepatitis B virus (HBV) in subjects already infected with human immunodeficiency virus (HIV). Researchers plan to determine the optimal vaccination strategy for achieving protective immunity to HBV infection in HIV-infected adults attending Mulago Hospital's HIV care clinic. Primary objectives are to assess: 1. The role of CD4-cell count and HIV viral loads on the HBV vaccine response. 2. The role of highly active antiretroviral therapy (HAART) on the HBV vaccine response. The secondary objective is to evaluate whether lack of HAART is associated with high rates of loss to follow-up.

NCT ID: NCT02315703 Completed - Healthy Clinical Trials

Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention

Start date: December 22, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of various regimens containing adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV), Modified Vaccinia Ankara (MVA)-Mosaic, and/or HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) components and to compare envelope binding antibody responses between the different vaccine regimens.

NCT ID: NCT02294422 Completed - Tracheal Damage Clinical Trials

Balloon Palpation vs Loss of Resistance Syringe for Safe Endotracheal Tube Cuff Pressure; a Randomized Clinical Trial

LOR-ETCP
Start date: April 2014
Phase: N/A
Study type: Interventional

This study is aimed at establishing whether use of loss of resistance syringe (LOR) that is traditionally used for identifying epidural space, is a better method for providing safe cuff pressures in adults intubated with cuffed endotracheal tubes. The conventional method is the use of pilot ballon palpation (PBP) to approximate cuff pressures but this is associated with airway damage. The study hypothesis states that both the loss of resistance syringe method and the pilot balloon palpation methods achieve the recommended endotracheal tube intracuff pressures.

NCT ID: NCT02282293 Completed - Malaria Clinical Trials

Reducing the Burden of Malaria in HIV-Infected Pregnant Women and Their HIV-Exposed Children (PROMOTE-BC2)

Start date: December 9, 2014
Phase: Phase 3
Study type: Interventional

This is a double-blinded, randomized controlled trial of 200 HIV-infected pregnant women living in Tororo, Uganda, an area of high malaria transmission. HIV-infected pregnant women between 12 and 28 weeks gestation will be randomized to receive enhanced malaria chemoprevention with monthly dihydroartemisinin-piperaquine (DP) versus monthly DP placebo. Their HIV-exposed children will receive the same prevention regimen from 2 to 24 months of age to which the mothers were randomized. All women will receive daily trimethoprim-sulfamethoxazole (TS) throughout the study per Uganda Ministry of Health guidelines. Children will also receive daily TS from 6 weeks to 24 months of age. TS will be considered a study drug only in infants and children beginning 6 weeks after cessation of breastfeeding and upon exclusion of HIV infection. Women and their children will be followed for 36 months after delivery. In a subset of the study population, the investigators will conduct an intensive pharmacokinetic study that will evaluate pharmacokinetic exposure of DP and EFV. The investigators will also measure HIV-related outcomes among the women enrolled in the study. The investigators will test the hypothesis that for HIV-infected mothers and HIV-exposed infants, that enhanced versus standard malaria chemoprevention in HIV-infected pregnant women and their children will reduce the incidence of malaria among children from 0 to 24 months of age and improve the development of naturally acquired antimalarial immunity.

NCT ID: NCT02273037 Completed - Stillbirth Clinical Trials

Intermittent Auscultation Using Handheld Doppler: a Randomized Controlled Trial Comparing Perinatal Outcomes in Uganda

Start date: January 2012
Phase: N/A
Study type: Interventional

A novel handheld Doppler has been developed which is rugged and is powered only by a hand crank. This study aims to test the use of this Doppler versus the Pinard horn to monitor the fetal heart rate in labour in a hospital setting in Uganda. The investigators propose that with its ease of use, both for the woman and midwife, midwives using the Doppler will identify more babies in need of prompt delivery and the risk of stillbirth and neonatal mortality will decline. In the research study, the investigators will compare the risk of stillbirths and neonatal mortality in two randomized groups of labouring women. The second part of the study consists of an audit of the documentation in labour by midwives. The partograph is an uncomplicated, low cost form on which observations during labour are documented. It includes three sections of information: fetal condition, maternal condition and labour progress. Although the use of a partograph during labour is strongly recommended by the WHO, there are limited published systematic evaluations of the correct use of the tool. The investigators aim to use this randomized trial design to assess rates of intrapartum stillbirth and neonatal mortality in the first 24 hours after delivery, and assess the quality of partographs comparing two groups. This trial will provide insights on the potential benefits of using handheld Doppler devices for intrapartum monitoring, and the audit of partograph quality will provide insights to improve care during labour. This study hypothesizes that the quality of partograph completion and of fetal heart rate monitoring may systematically differ between the Doppler and Pinard groups.

NCT ID: NCT02245126 Completed - Post Operative Pain Clinical Trials

The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision

Start date: January 2013
Phase: N/A
Study type: Interventional

Using routinely collected data to compare different concentrations of locally applied anaesthetic drugs and determine which concentrations give better pain control during voluntary medical Male circumcision.

NCT ID: NCT02245022 Completed - HIV Clinical Trials

Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study

DolPHIN1
Start date: March 14, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Aim: To evaluate dolutegravir (DTG) pharmacokinetics in pregnant HIV-infected women Rationale: In developing countries many women present with a new HIV diagnosis in late pregnancy, and are at high risk of transmitting infection during delivery. Moreover, women may acquire NNRTI resistance from primary transmission, or use of nevirapine (NVP) in previous pregnancies. In these circumstances, DTG is likely to be more effective in reducing mother to child transmission of HIV than NNRTI-based regimens. Study design: HIV positive pregnant women presenting with untreated HIV infection in late (≥28 -36 weeks gestation) pregnancy will be randomised 1:1 to receive DTG (50mg once daily) or standard of care (nevirapine or efavirenz) + 2 NRTIs. PK (0-24h) profile will be sampled in third trimester and post-partum. Although this is primarily a PK study (and has been powered as such) randomisation is included to allow comparison of plasma HIV VL responses against standard of care (NVP or EFV) and is essential for evaluation of secondary endpoints of safety and efficacy of DTG in pregnancy. Number recruited N=30 per group

NCT ID: NCT02244398 Completed - Clinical trials for HIV Testing and Counseling

Community-based Delivery of Integrated Family Planning/HIV Testing and Counseling Services in Uganda

Start date: February 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the feasibility and acceptability of adding HIV testing and counseling (HTC) services to the family planning (FP) services provided by community health workers in Uganda.