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NCT ID: NCT00489658 Terminated - Clinical trials for Trypanosomiasis, African

Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda

NECS
Start date: October 2002
Phase: Phase 2/Phase 3
Study type: Interventional

This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness) patients.

NCT ID: NCT00330148 Terminated - Clinical trials for Trypanosomiasis, African

Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis

Start date: March 2001
Phase: Phase 3
Study type: Interventional

The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on two molecules officially registered: melarsoprol, the most commonly used, has a poor safety profile and is becoming ineffective due to parasite resistance; and eflornithine, with better tolerance but more complicated and expensive to implement in endemic countries. nifurtimox, registered only for Chagas' disease but used off-label since the 1970’s in series of cases of HAT, is at present the only other available alternative. The very limited number of compounds available, the lack of prospects for the development of new products and the emergence of resistance are arguments for the use of therapeutic combinations. This study evaluates the efficacy and safety of three drug combination therapies: melarsoprol-nifurtimox, melarsoprol-eflornithine and eflornithine-nifurtimox.

NCT ID: NCT00259142 Terminated - Malaria Clinical Trials

Acceptability and Cost Effectiveness of Home Based Management of Fever: Different Strategies

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

Malaria remains a major cause of morbidity and mortality particularly among children < 5 years in Uganda. Due to inaccessibility many children die before they reach the health facility. The Home Based Management of Fever (HBMF) strategy was adopted in Uganda as a mean to improve access to early and appropriate treatment of fever at community level. Pre-packed chloroquine with sulphadoxine-pyrimethamine (HOMAPAK) is provided through Community Drug Distributors(CDDs). Initial evaluation showed underutilization of the CDDs (15%). This cast doubt on community acceptability, accessibility as well as its feasibility and cost effectiveness. This 3-year project intends to compare community acceptability and cost effectiveness of two HOMAPAK distribution methods. The current CDD-based HOMAPAK distribution versus home-based HOMAPAK distribution. The study hypothesis is that "home-based HOMAPAK distribution is more acceptable to the community and more cost effective than the CDD based HOMAPAK A non randomised community study will be conducted in two sub-counties of Mukono district. In the control arm, HOMAPAKs will be distributed through the CDDs while in the intervention arm, HOMAPAKs will be directly distributed to the caretakers in the homes. The study population are caretakers and their children < 5 years. At baseline a survey (Phase 1) with a sample size 657 in each study area will assess the common drugs stocked at home to treat malaria and the health seeking behaviour for malaria for children < 5 years and to determine the prevalence of malaria parasitaemia and anaemia among children < 5 years. Phase 2 includes the intervention. The villages will be assigned to either the control or intervention arm. Anaemia and malaria parasitaemia among children with fever will be assessed through active case finding. The impact of either distribution system on accessibility, acceptability, sustainability, compliance, cost effectiveness and malaria morbidity will be assessed during the evaluation phase. Health education messages on malaria prevention and treatment will be given to both communities. Drug misuse will be limited by distributing HOMAPAKs according to the number of children <5years in each household. HOMAPAK will only be replenished after the caretaker returns a used packet to the CDD.

NCT ID: NCT00153777 Terminated - HIV Infection Clinical Trials

Cellulose Sulfate and HIV Transmission Among Women

Start date: July 2005
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine the effect of cellulose sulfate on the transmission of HIV to women via vaginal intercourse. The secondary objectives are the effect on the transmission of gonorrhea and chlamydia via the same route. The study hypothesis is that there will be no effect.

NCT ID: NCT00119093 Terminated - HIV Infections Clinical Trials

Home-based AIDS Care Project

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

The Home-based AIDS care program pilot project delivers and monitors antiretroviral (ARV) and tuberculosis (TB) medications at the homes of 1,000 people with HIV living in a rural area of Uganda. This study is evaluating how well this program reduces illness and prolongs the life of participants, changes sexual behavior, influences levels of adherence to medication, affects aspects of perceived stigma by participants and their communities, and other operational components of the program including cost-effectiveness. This study is evaluating the hypothesis that frequent home visits by a trained lay person with a standard questionnaire is equivalent in terms of health outcomes to frequent viral load and CD4 cell count measurements.