There are about 751 clinical studies being (or have been) conducted in Kenya. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this study is to assess the efficacy and safety of SSG 30 days alone, PM 21 days alone and SSG and PM as a combination course of 17 days in the treatment of patients with VL.
The goals of this research are: 1) To test the efficacy of a self-care symptom management manual by examining whether people who use the manual find it to be useful; 2) To examine symptom and demographic data related to self-care behaviors, symptom control, medication adherence and enhanced quality of life. The University of California, San Francisco is the coordinating site for this multi-site international study.
This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas. This vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum. Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve adults and 40 adults and 90 children living in malaria-endemic regions. This study will investigate whether the candidate vaccine prevents malaria disease for 6 months post-vaccination. One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine (RabAvert).
The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B vaccine to the African adults to establish safety and immunogenicity in this population. Preliminary indication of vaccine efficacy with this adjuvant will be established by monitoring the time to the first infection with Plasmodium falciparum.
Following significant reduction in antiretroviral drug prices over the past two years, more HIV-1 infected African adults and children are gaining access to treatment. However, due to complex drug regimens that have to be taken continuously, suboptimal adherence is likely to be a formidable challenge. As programs providing antiretroviral drugs in Africa scale up, achievement of excellent adherence is a high priority as this will result in maximum benefits from the drugs and forestall development of resistant virus. A better understanding of predictors of pediatric HAART adherence in African children is essential in order to formulate feasible, culturally appropriate, strategies to monitor and enhance adherence. There is also urgent need to evaluate simple, inexpensive interventions that are widely applicable in the African setting. The medication diary has been used empirically among HIV infected adults and children in Western countries, mainly as a tool for monitoring and to a lesser extent improving HAART adherence. Literacy levels have risen significantly in most African regions over the past few years, and the diary can also be further modified using pictures to suit parents of different literacy levels. We propose to conduct a randomized control trial to determine the effect of medication diaries and counseling versus counseling alone on HAART-adherence in HIV-1 infected children and their parents/caregivers in Nairobi Kenya.
The University of Washington has received funding to conduct a proof-of-concept trial to assess the impact of suppression of genital herpes on HIV infectiousness. This study (the Partners in Prevention Study) will enroll HIV discordant heterosexual couples in which the HIV-infected partner is co-infected with herpes simplex virus type 2 (HSV-2) to test the efficacy of twice daily (bid) acyclovir (400 mg) given to the HIV-infected partner to prevent transmission to his/her HIV negative partner(s). This randomized, double-blind, placebo-controlled proof-of-concept trial will provide evidence for the efficacy of HSV-2 suppression with daily acyclovir on HIV transmission among HIV-discordant couples among whom the HIV-positive partner is also HSV-2 seropositive with CD4 >250. The researchers hypothesis is that, by decreasing the frequency and amount of genital HIV shedding, standard doses of daily acyclovir 400 mg bid will reduce the rate of HIV transmission by 50% in HIV-discordant couples among whom the HIV-infected partner is HSV-2 positive. Under the study protocol version 4.1.1, 3000 HIV-discordant heterosexual couples in which the HIV-positive partner is HSV-2 positive and has a CD4 count >250 will be recruited; participants will be followed for up to 2 years. A 4% per year HIV incidence in the placebo arm is assumed. The first study site began enrolling participants on 17 November 2005. As of September 2006, 14 sites in Eastern and Southern Africa had participated in recruiting the 2300 HIV-discordant couples enrolled to date.
The purpose of this study is to see if taking medication once a month can help to decrease the risk of vaginal infections. Additionally, researchers will study whether personal habits, such as douching, bathing, and sexual practices can influence the risk of vaginal infections. Vaginal infections may influence the risk of becoming infected with HIV-1 and other sexually transmitted diseases (STDs). Study participants will include 400 female prostitutes ages 16 and older, living in Mombasa. Study procedures will include sexual behavior questions, physical examinations including pelvic exams, testing of vaginal and cervical secretions for STDs, urine collection and blood samples. Participants will receive 2 different types of pills to treat vaginal infections (metronidazole or fluconazole) or placebo (contains no medication). Participants will be involved in study related procedures for 1 year and will return to the study clinic at one month intervals.
Identifying new approaches for preventing breastmilk transmission of HIV-1 is an important research priority. To this end, clinical trials are underway to evaluate the efficacy of HAART (zidovudine, lamivudine, nevirapine) during late pregnancy/lactation versus zidovudine/nevirapine peripartum for prevention of breastmilk HIV-1 transmission. It is important to understand the mechanism of effect of these antiretroviral (ARV) strategies on prevention of breastmilk HIV-1 transmission. This phase II trial will compare HAART vs peripartum zidovudine/nevirapine for effect on breastmilk HIV-1, breastmilk HIV-1 specific immune responses, and infant HIV-1 specific immune responses. 100 pregnant HIV-1 seropositive women in Nairobi with CD4 counts between 200 to 500 who have chosen to breastfeed will receive either ARV regimen. Mother-infant pairs will be followed for 1 year after delivery. Home visits will be conducted in the first month (~10 visits) to collect 2-5 mls of breastmilk per visit. Mother-infant pairs will be seen in the study clinic with maternal blood and breastmilk and infant blood collected at months 1, 3, and 6 for HIV-1 and HIV-1 Elispot assays. Breastmilk HIV-1 RNA and DNA levels will be quantified in Dr. Overbaugh's laboratory in Seattle and Elispot assays conducted in Nairobi with validation of a subset in Dr. Rowland-Jones laboratory in Oxford. Viral loads, decay curves, half-life, and re-population following ARV cessation will be estimated for each regimen and regimens compared. These studies will provide insight into the viral and immune responses to ARV regimens proposed for prevention of breastfeeding HIV-1 transmission and will be important for rational design of future interventions. After taking into account, estimated loss to follow-up, the targeted sample size with outcome data was 80 women, 40 in each trial arm, estimating undetectable breast milk HIV-1 RNA levels in the HAART arm and median breast milk HIV-1 RNA levels of 3.0 log10 in women receiving ZDV/NVP.
This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16 with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks participants can continue to take olmesartan medoxomil (OM) for up to an additional 46 weeks.
Plasmodium falciparum malaria and HIV are among the most important infectious diseases in sub-Saharan Africa. Approximately two-thirds of the estimated 35 million HIV infected persons live in sub-Saharan Africa. Of the 300-500 million annual cases of malaria infection occurring worldwide, about 90% of P. falciparum infections occur in sub-Saharan Africa, resulting in approximately 1 million deaths, mostly in children under five years of age. It is clear that HIV and malaria are responsible for substantial disease, suffering, and an enormous economic burden on the people who can least afford it. Although a study in 1993 in Tanzania showed significantly higher prevalence of malaria infections in HIV-positive compared to HIV negative adults, until recently there have been few studies showing any association between the two infections. We conducted a study to measure the efficacy of the then-first line antimalarial drug (sulfadoxine-pyrimethamine) among patients in three study arms: those who were HIV negative, those who were HIV infected with CD4 cell counts < 200, and among HIV infected patients with CD4 cell counts >= 200. Our hypothesis is that patients with HIV infection and low CD4 cell count will not respond to antimalarial therapy as well as patients who are HIV infected with higher CD4 cell counts or who are HIV negative.