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NCT ID: NCT00130247 Completed - Tuberculosis Clinical Trials

Tuberculosis Treatment Shortening Trial

Start date: April 8, 2002
Phase: Phase 3
Study type: Interventional

Tuberculosis (TB) is a serious infection that can affect the lungs and other parts of the body. The usual way to treat TB is to take 4 medicines by mouth every day for 2 months, then take 2 of the same medicines for 4 more months, for a total of 6 months. The purpose of this study is to see if taking 4 months of TB medicines is as effective in curing some TB patients as taking 6 months of TB medicines. Study participants will include 758 human immunodeficiency virus (HIV)-non-infected individuals, ages 18-60. Participants will be treated with 4 standard drugs called isoniazid, rifampicin, pyrazinamide and ethambutol. All individuals will take TB medicines for at least 4 months. After 4 months of treatment, if no TB germs are growing in sputum samples, participants will be assigned to either stop taking TB medicine (4 months of treatment) or to continue taking TB drugs for 2 more months (6 months of treatment). Participants will be involved in study procedures for up to 30 months.

NCT ID: NCT00124540 Completed - Clinical trials for Postpartum Hemorrhage

Misoprostol for Preventing Postpartum Hemorrhage

Start date: August 2005
Phase: N/A
Study type: Interventional

This hospital-based, multicenter, randomized, placebo-controlled trial will assess the effects of misoprostol as part of active management of the third stage of labor on postpartum blood loss, complications, and side effects. Twelve hundred eligible women will receive routine oxytocics (oxytocin 5-10 IU) plus either 400 mcg sublingual misoprostol or placebo during or immediately after delivery. The primary outcome will be measured blood loss of =>500 mls within one hour after enrollment.

NCT ID: NCT00123968 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to an HIV-1 Vaccine (VRC-HIVDNA016-00-VP) and a Vaccine Booster (VRC-HIVADV014-00-VP) in HIV Uninfected East African Adults

Start date: May 2006
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the study is to determine the safety of and immune response to an investigational HIV vaccine, VRC-HIVDNA016-00-VP, and a vaccine booster, VRC-HIVADV014-00-VP, in HIV uninfected adults from Kenya, Tanzania, and Uganda.

NCT ID: NCT00123552 Completed - Malaria Clinical Trials

Longitudinal Antimalarial Combinations in Uganda

Start date: November 2004
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare different ways of treating uncomplicated malaria in a group of Ugandan children. The study will be divided into 2 parts. Part 1 of the study will consist of 600 children, ages 1-10, living in the Mulago III Parish of Kampala. Approximately 90 children living in the same household as children from the Phase 1 portion of the study will be enrolled in Phase II of this study. Participants in Phase II of the study will receive an insecticide treated net to cover their bed. Over the course of the study, participants will be tested for malaria when they present to the clinic with a fever or illness. Participants that test positive for malaria will be given 1 of 3 possible study drug combinations. Study procedures will include physical exams and blood samples. Children will participate for about 3 years. Protocol 05-0110 is a study related to this protocol.

NCT ID: NCT00122941 Completed - HIV Infections Clinical Trials

Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda

MMS
Start date: June 2005
Phase: Phase 3
Study type: Interventional

Micronutrient deficiencies are common in HIV infected children and are aggravated by poor nutrition, especially in poor resource countries such as Uganda. It appears that micronutrient deficiencies contribute to immune dysfunction, increased morbidity and HIV disease progression. Hitherto, there has been no randomised controlled trial to assess the effect of multiple micronutrient supplementation on morbidity and mortality in HIV infected children in Africa. Therefore, the investigators shall carry out a randomised controlled trial to determine the effect of multiple micronutrient supplementation on morbidity, weight gain and mortality among HIV infected children aged 1 to 5 years in Uganda. Hypothesis: Daily administration of twice the recommended dietary allowance (2RDA) of multiple micronutrients to HIV infected children aged one to five years, for 6 months, will reduce all cause mortality from 24% to 14.4% in one year and result in a weight gain difference of 150 grams.

NCT ID: NCT00118027 Completed - Pregnancy Clinical Trials

A New Approach to Deliver Malaria Preventions to Pregnant Women at a Community Level in Uganda

Start date: May 2003
Phase: N/A
Study type: Interventional

SUMMARY Background: Malaria is the leading cause of morbidity and mortality among pregnant women in Uganda. Although effective tools for prevention and control of malaria exist, their delivery presents a problem. Intermittent presumptive treatment (IPT) with sulfadoxine-pyrimethamine (SP) is effective, yet >60% of women in Uganda do not get it as < 40%, attend antenatal care. Effective ways of delivering IPT with SP to pregnant women at a community level need to be developed. This study assessed whether community based resource persons like traditional birth attendants (TBAs), community reproductive health workers (CRHWs), adolescent peer mobilizers (APMs) and drug-shop owners (DSV) can distribute IPT with SP to pregnant women. Objectives: The objectives of this study were: - To assess community based approaches for delivering malaria prevention to pregnant women in Uganda; - To assess community perceptions, beliefs and practices associated with malaria treatment and prevention in pregnancy; - To assess whether community based resource persons can deliver IPT to pregnant women and reach those most at risk; - To assess the impact of IPT on anaemia and pregnancy outcome; - To estimate cost-effectiveness of the approaches and assess the acceptability and sustainability of the approaches. Methods: The study was conducted in 5 sub-counties of the Mukono district, situated on the shores of L. Victoria in Central Uganda. The district is hyper-endemic for malaria. 25 parishes with a total population of 75,000 people were used to test the new approaches. Phase 1 obtained qualitative data on community perceptions, beliefs and practices associated with malaria prevention in pregnancy. Phase 2 was an intervention study that assessed distribution of IPT to pregnant women by TBAs, CRHWs, APMs and DSVs compared with health units. Pregnant women of all parities were enrolled. Key resource persons in each parish were identified to sensitise the communities on the intervention. Data was collected regarding: timing of the first dose of SP, proportion of women who complete two doses of SP, birth weight of babies, proportion of low birth-weight babies, and proportion of adolescent pregnancies. The third phase of the study evaluated the sustainability of the approaches. Work Plan: The first phase of the study took two months. The second phase took 14-16 months. Data analysis was expected to take 12 months.

NCT ID: NCT00110305 Completed - Clinical trials for Human Immunodeficiency Virus Type 1

A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines

Start date: June 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.

NCT ID: NCT00108862 Completed - Tuberculosis Clinical Trials

Immediate Versus Deferred Start of Anti-HIV Therapy in HIV-Infected Adults Being Treated for Tuberculosis

STRIDE
Start date: August 2006
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine the best time to begin anti-HIV treatment in individuals who have HIV and tuberculosis (TB). Study hypothesis: Immediate antiretroviral therapy (ART), initiated after approximately 2 weeks of TB treatment, will reduce the frequency of other AIDS-defining illnesses and death in HIV-infected participants being treated for TB by at least 40% at week 48 when compared to deferred ART, initiated at after 8-12 weeks of TB treatment.

NCT ID: NCT00099632 Completed - HIV Infections Clinical Trials

Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy

Start date: March 2006
Phase: Phase 2
Study type: Interventional

HIV infected pregnant women may take single-dose nevirapine (SD NVP) prior to giving birth to prevent mother-to-child transmission (MTCT) of HIV. However, SD NVP may cause NVP resistance in the mother, potentially ruling out some treatment options in the future. The purpose of this study is to determine which of three anti-HIV drug regimens most effectively reduces the development of maternal NVP resistance in HIV infected pregnant women. The effectiveness of short-term (7 day therapy) versus long-term (21-day therapy) regimens will also be compared. The study hypotheses are: 1) intrapartum SD NVP with a 21-day course of antiretroviral therapy (ART) results in less frequent selection of NVP-resistant HIV-1 variants than intrapartum SD NVP with a 7-day course of ART, and 2) a 7- or 21-day course of lamivudine/zidovudine (3TC/ZDV), emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), or lopinavir/ritonavir (LPV/r) following SD NVP will not select nucleoside reverse transcriptase inhibitor (NRTI)- or protease inhibitor (PI)- resistant HIV-1 variants.

NCT ID: NCT00098163 Completed - HIV Infections Clinical Trials

Safety of and Immune Response to an HIV-1 Vaccine (ALVAC-HIV vCP1521) in Infants Born to HIV Infected Mothers

Start date: n/a
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine, ALVAC-HIV vCP1521, given to infants born to HIV-1 infected mothers in Uganda.