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NCT ID: NCT01043575 Completed - Clinical trials for Smear Positive, Pan-sensitive, Pulmonary Tuberculosis

High Dose Rifapentine Pharmacokinetics, Tolerability and Safety Dosage Rifapentine for Treatment of Tuberculosis

TBTC-29PK
Start date: April 2009
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to characterize rifapentine drug levels in patients with TB in relationship to its effectiveness in treating TB and any adverse effects experienced by participants.

NCT ID: NCT01028547 Completed - Clinical trials for Postoperative Nausea and Vomiting

Antiemetic Efficacy and Safety of Dexamethasone in Obstetric Surgical Patients

Start date: January 2010
Phase: N/A
Study type: Interventional

This is a randomised controlled double blinded clinical trial to determine the antiemetic efficacy and safety of either 8 mg of dexamethasone or normal saline (placebo) given 1 hour before induction of either spinal or general anaesthesia in 2 arms (of 150 each).

NCT ID: NCT01025830 Completed - HIV/AIDS Clinical Trials

Triomune Bioequivalence With Innovators

Start date: February 2006
Phase: Phase 4
Study type: Interventional

The null hypothesis is that there is a difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans and the alternative hypothesis is that there is no difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans. This is a non-inferiority study.

NCT ID: NCT01024426 Completed - Malaria Clinical Trials

Impact of Enhanced Health Facility Care in Uganda

Start date: December 2010
Phase: Phase 4
Study type: Interventional

The investigators propose to assess whether an intervention to build capacity and improve delivery of drugs and diagnostics at government-run health facilities improves the health of children and quality of care delivered, as compared to 'standard care' currently available at health facilities, supplemented by services provided through the private sector and community-based interventions. The target population will be divided into 20 clusters, defined as the catchment area of lower-level public health facilities. Clusters will be randomized to the health facility intervention (HFI) or to standard care delivered from government-run health facilities, supplemented by services provided through the private sector and community-based interventions. The intervention is designed to address barriers to delivering quality care at health centers and will focus on three components: (1) training in-charges in health center management, (2) providing training to health workers in fever case management and patient-centered services, and (3) ensuring adequate supplies of artemether-lumefantrine and RDTs. Outcomes will be measured in three distinct populations: (1) cross-sectional surveys of children under 15 years randomly selected from households within the clusters; (2) a cohort of children under five randomly selected from households within the clusters and followed for 2 years; and (3) patients attending all government-run health facilities, including children under five and their caregivers participating in exit interviews on selected days every six months. The primary outcome of the study is prevalence of anemia in children under five.

NCT ID: NCT00997607 Completed - Ebola Virus Disease Clinical Trials

Evaluating an Ebola and a Marburg Vaccine in Uganda

Start date: February 2010
Phase: Phase 1
Study type: Interventional

This study will test two new vaccines, one for Ebola and one for Marburg virus, to see if they are safe, if they have side effects, and if they create an immune response in people who receive them.

NCT ID: NCT00993031 Completed - HIV Infections Clinical Trials

Protease Inhibitors to Reduce Malaria Morbidity in HIV-Infected Pregnant Women

PROMOTE-PIs
Start date: December 15, 2009
Phase: Phase 3
Study type: Interventional

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 counts at high risk of malaria. The study is designed to test the hypothesis that pregnant women receiving a PI-based ART regimen will have lower risk of placental malaria compared to pregnant women receiving a non-PI based ART regimen. The primary study endpoint of the study is placental malaria. This study also enrolls the infants of these women at the time of delivery.

NCT ID: NCT00988039 Completed - HIV Clinical Trials

Europe-Africa Research Network for Evaluation of Second-line Therapy

EARNEST
Start date: March 2010
Phase: Phase 3
Study type: Interventional

The trial aim is to ascertain what, if anything, needs to be combined with a boosted protease inhibitor (bPI) backbone in second-line therapy in order to maximize the chance of a good clinical outcome following WHO-defined failure on a first-line nucleoside reverse transcriptase inhibitor (NRTI) and NNRTI-containing regimen with probable extensive NRTI and NNRTI resistance mutations.

NCT ID: NCT00978068 Completed - HIV Infections Clinical Trials

HIV Protease Inhibitors for the Prevention of Malaria in Ugandan Children

PROMOTE-PEDS
Start date: September 2009
Phase: Phase 3
Study type: Interventional

HIV and malaria are major causes of morbidity and mortality in Sub-Saharan Africa and children bear the greatest brunt of both diseases. No single existing intervention is likely to control malaria in Africa. Rather, improvements in malaria prevention are likely to come from strategies that employ multiple proven interventions targeting different populations. HIV-infected children represent one of the most vulnerable subpopulations in these countries. It is possible that the use of protease inhibitor (PI) - based antiretroviral therapy (ART) in HIV-infected children living in areas of high malaria transmission could prevent malaria in this vulnerable population. An effective remedy that offers the possibility to further reduce malaria risk, such as PIs, is highly desirable. This study will determine whether a PI based ART regimen will reduce malaria among children living in a malaria endemic area of Uganda and receiving insecticide-treated bed nets (ITN) and TS. This study will compare two different ART regimens. Children enrolled in the study will start or continue to receive either standard Ugandan first line treatment ART regimen (NNRTI+2 NRTIs) or an ART regimen containing the HIV protease inhibitor (lopinavir/ritonavir +2 NRTIs) and followed for a period of 24 months.

NCT ID: NCT00972192 Completed - HIV Clinical Trials

Effectiveness of Inpatient Voluntary Counseling and Testing (VCT) in Uganda

Start date: February 2004
Phase: N/A
Study type: Interventional

This study compared the effectiveness of inpatient routine VCT to referral for post-discharge VCT in terms of the number of new HIV infections identified, linkage to care for HIV infected individuals and reduction in HIV risk behavior.

NCT ID: NCT00948896 Completed - Malaria Clinical Trials

Chemopreventive Therapy for Malaria in Ugandan Children

PROMOTE-Chemop
Start date: June 2010
Phase: Phase 3
Study type: Interventional

Young African children living in high transmission areas suffer the greatest burden of malaria. In most African countries, such as Uganda, the only current preventive measure against malaria in high transmission settings is the use of insecticide treated bednets (ITNs). Preliminary data show that even in the setting of ITN use, young children living in a high transmission setting suffer almost 4 episodes of clinical malaria per year, highlighting the need for new preventive strategies. Chemopreventive strategies offer a potential means of reducing the burden of malaria among young children living in a high transmission setting. This study will compare the efficacy and safety of 3 promising chemopreventive strategies (monthly dihydroartemisinin-piperaquine, monthly sulfadoxine-pyrimethamine, daily trimethoprim-sulfamethoxazole) with the current standard of no chemoprevention and will be conducted in two distinct patient populations: 1) HIV-unexposed children (HIV-uninfected children born to HIV-uninfected mothers) and 2) HIV-exposed children (HIV-uninfected children born to HIV-infected mothers). The intervention will begin in HIV-unexposed children when they reach 6 months of age, the time at which the incidence of malaria begins to increase, and will be continued until the children reach 24 months of age, which prior data suggest is when the incidence of malaria begins to decline due to the development of semi-immunity. In addition, study participants will be followed for one additional year following chemopreventive therapy to examine for "rebound" in the incidence of malaria following our intervention. HIV-exposed children will begin the intervention when they have completed breastfeeding and have been confirmed to remain HIV-uninfected. The intervention will continue until study participants reach 24 months of age and then the study participants will be followed for an additional year to examine for rebound in the incidence of malaria. It is anticipated that the results of this study will provide valuable comparative data on the effect of different chemopreventive strategies on malaria incidence in two distinct patient populations at high risk for malaria. In addition it is anticipated the results of this study will provide insight into the development of naturally acquired antimalarial immunity in the setting of chemopreventive therapy that will differ in terms of the drug regimens, the age at which the intervention is started, and the HIV status of the mothers.