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NCT ID: NCT00507221 Completed - HIV Infections Clinical Trials

Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression

THE or PHE
Start date: February 2008
Phase: N/A
Study type: Interventional

Abstract: Over 25 million HIV-1 infected individuals are currently living in Africa and as many as 50-90% may be co-infected with soil transmitted helminths such as roundworms, hookworms or whipworms. Helminth infection in HIV-1-infected individuals may increase HIV-1 RNA levels and increase the rate of progression of HIV-1 to AIDS. Studies have also shown that successful treatment of helminth co-infection (as documented by clearance of helminth eggs in stool) led to a significant decrease in HIV-1 plasma viral load (-0.36 log10). This change in viral load was significantly greater than that seen in those individuals without documented clearance of their helminth co-infection (+0.67 log10) (p=0.04). Studies conducted in Africa have shown an estimated 2.5-fold increased risk for sexual transmission of the HIV-1 for each log increase in plasma HIV-1 viral load. In addition to direct effects on plasma viral load, the rate of CD4 cell decline in helminth infected individuals may be directly impacted by the significant immune activation seen with such co-infection. The investigators propose a randomized controlled trial examining the potential benefits of routine empiric helminth eradication in HIV-1 infected adults who do not yet qualify for antiretroviral (ARV) therapy in Kenya. The current standard of care of symptomatic diagnosis and treatment will be compared to a systematic empiric scheduled de-worming program for HIV infected adults. The investigators will compare markers of disease progression including rate of CD4 decline and changes in HIV-1 RNA levels between the two treatment arms.

NCT ID: NCT00469547 Completed - Clinical trials for Sexually Transmitted Infections

62% & 15% Ethanol in Emollient Gel as Topical Male Microbicides

Start date: November 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to look at the safety and acceptance of using a microbicide (product that kills germs) gel to clean the genital area. Microbicide gel is used by hospital workers to clean their hands to kill germs. Researchers hope to use information from this study to conduct a larger study to determine if the microbicidal gel protects men against sexually transmitted infections, including HIV. Thirty healthy uncircumcised Kenyan men, 18 years and older, working in the fishing industry in Kisumu will be recruited. Participants will complete a questionnaire about their background and sexual practices. A researcher will conduct a detailed examination of the genital area with a magnifying glass. A blood and urine sample will be collected to test for infection. Each participant will use both the microbicidal gel and a placebo (contains no active ingredient) gel at different times during the study, and the results will be compared. Volunteers will participate up to 8 weeks.

NCT ID: NCT00463307 Completed - Clinical trials for Schistosomiasis Mansoni

Evaluation of the Use of a Urin Test Strip to Determine the Spread of Schistosoma Infections in Areas Where Schistosomiasis Infections Are Low in Kenya

Start date: April 2006
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the use of a urine test strip in diagnose schistosoma mansoni in areas of Kenya where the rate of infections are low. The hypothesis is that the urine strip test is a superior tool to the conventional parasitological tools used to diagnose schistosomiasis mansoni infections in area where there is low transmission

NCT ID: NCT00459615 Completed - Falciparum Malaria Clinical Trials

Phase II Dose Ranging Study of Artesunate

Start date: April 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare four regimens using US FDA GMP intravenous artesunate for the treatment of uncomplicated Plasmodium falciparum malaria to identify the most effective treatment regimen as determined by rapidity of parasite clearance by microscopy.

NCT ID: NCT00425763 Completed - Malaria Clinical Trials

Efficacy of Amodiaquine-artesunate in Children Aged 6-59 Months With Uncomplicated P. Falciparum Malaria

IPTi DRWG
Start date: May 2007
Phase: Phase 4
Study type: Interventional

We will be studying the clinical efficacy of amodiaquine-artesunate currently being studied in an intermittent preventive therapy in infants (IPTi)trial in the same area in order to correlate preventive efficacy seen in IPTi with efficacy for treatment of symptomatic malaria for each regimen.

NCT ID: NCT00422084 Completed - Malaria Clinical Trials

Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients

Start date: January 2007
Phase: Phase 3
Study type: Interventional

The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia.

NCT ID: NCT00414479 Completed - Malaria Clinical Trials

Assessment of Anaemia Attributable to Schistosomiasis in School Children in Kenya: Mechanisms and Effect of Treatment

Start date: July 2006
Phase: N/A
Study type: Observational

The purpose of this study is to determine the extend and the nature of anemia in school children and the correlation between anemia and schistosomiasis infections, malaria infections and/or malnutrition (iron deficiency).

NCT ID: NCT00393757 Completed - Clinical trials for Plasmodium Falciparum Malaria

Malaria Transmission and Immunity in Highland Kenya

Start date: October 2006
Phase:
Study type: Observational

The purpose of this study is to see why malaria epidemics occur in highland areas in Kenya. A better understanding of factors contributing to malaria may be necessary for malaria vaccine planning. These factors include interactions between age, where malaria is passed from mosquitoes to people, immune system (how the body fights infection) responses and other factors that contribute to malaria in epidemic-prone areas. About 6400 people from the villages of Kapsisiywa and Kipsamoite will participate. Study procedures will include in home surveys, which will involve a census and an interview by researchers. Blood samples and smears will be collected from some volunteers in both communities to understand how the body protects itself from malaria and to check for malaria parasites. Twice each month, random houses will be selected from 3 places in the village to measure the number of mosquitoes in the home. Participants may be involved in the study for up to 4 years.

NCT ID: NCT00386763 Completed - Malaria Clinical Trials

Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

Start date: August 2006
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.

NCT ID: NCT00380393 Completed - Malaria Clinical Trials

Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.

Start date: January 3, 2007
Phase: Phase 2
Study type: Interventional

This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.