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NCT ID: NCT00444379 Completed - HIV Infections Clinical Trials

Anti-Retrovirals for Kaposi's Sarcoma

ARKS
Start date: April 2007
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to determine whether a protease inhibitor-based antiretroviral regimen is more efficacious than a non-nucleoside reverse transcriptase inhibitor-based antiretroviral regimen in promoting the regression of KS tumor burden in persons with AIDS-related KS in Africa.

NCT ID: NCT00434070 Completed - Clinical trials for Acquired Immunodeficiency Syndrome

Relationship of Viral Resistance Development to CD4 Monitoring Alone or With Viral Load Monitoring

Start date: February 7, 2007
Phase:
Study type: Observational

This study will examine whether HIV-infected patients are more likely to develop resistance to antiretroviral therapy if their blood is not monitored for the number of viruses (viral load) in the body. A virus that changes (mutates) over time may become resistant to certain types of medicine. This resistance may affect future treatment options. This study will compare the amount of virus in the blood of HIV-infected patients who have been monitored for viral load with the amount of virus in the blood of patients who have not been monitored for viral load. For patients who have detectable virus, the type of resistance (mutations) of the virus will be determined by comparing the components of the virus with that of a virus that is known not to be resistant. HIV-infected patients 18 years of age or older who are being treated at the Infectious Diseases Institute at Mulago Hospital at Makerere University in Kampala, Uganda, may be eligible for this study. Participants are interviewed about the treatments they have received for HIV and how they usually take their anti-HIV drugs. They also have a blood sample drawn for research tests.

NCT ID: NCT00425984 Completed - HIV Infections Clinical Trials

Male Circumcision for HIV Prevention in Rakai, Uganda

Start date: August 2002
Phase: Phase 3
Study type: Interventional

Circumcision in HIV unifected men may reduce the likelihood of becoming infected with HIV, reduce sexually transmitted infections (STIs) in men, not engender increases in sexual risk behaviors, and be acceptable to men as a procedure for preventing HIV. The purpose of this study is to evaluate circumcision in HIV uninfected men in terms of safety and ability to prevent HIV infection.

NCT ID: NCT00405821 Completed - HIV Infections Clinical Trials

Acyclovir to Treat Patients Co-infected With HIV and Herpes Viruses in Uganda

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

This study will determine whether acyclovir, a medicine used to treat herpes simplex virus 2 (HSV-2), can slow down the progression (worsening) of HIV disease in people with both HIV and HSV-2 infections. HSV-2 increases the amount of HIV virus in the blood of infected people and may make HIV progress faster. The study will evaluate: "Whether people who take acyclovir can avoid antiretroviral treatment until later in their lives "Whether people who take acyclovir get fewer genital ulcers "How well people are able to take acyclovir and any side effects they experience from it "Differences in the amount of HIV virus in the blood of patients who are and are not taking acyclovir, and how HIV/AIDS is different in these patients. People 18 years of age and older living in the Rakai district of Uganda who are infected with both HIV (early stage disease) and HSV-2 may be eligible for this study. Participants are randomly assigned to take the study drug, acyclovir, or a placebo (look-alike pill with no active ingredient) daily for 2 years. During this time, they visit the clinic once a month for a routine physical examination. Patients who develop genital ulcers or complications of HIV are treated for the problem, and patients whose HIV disease progresses, requiring them to begin antiretroviral therapy, are treated accordingly.

NCT ID: NCT00399074 Completed - Malaria Clinical Trials

Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia

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

Malaria is fatal and increases the risk of death among children with sickle cell anemia. Chemoprophylaxis significantly improves quality of life in these children. In Uganda Chloroquine is the drug of choice for prophylaxis and yet it's effectiveness is limited due to high levels of resistance throughout the country. Intermittent presumptive treatment with sulfadoxine - Pyrimethamine a new approach to malaria prevention, has shown great potential in reducing incidence of malaria and anaemia among high risk groups such as pregnant women and infants. However no studies have been done in Uganda to determine if presumptive treatment with sulfadoxine- pyrimethamine reduces the incidence of malaria in children with sickle cell anaemia. Hypothesis : Presumptive treatment with sulfadoxine- Pyrimethamine is better than weekly chloroquine in reducing incidence of malaria in children with sickle cell anaemia.

NCT ID: NCT00397150 Completed - Diarrhea Clinical Trials

PROMISE EBF: Safety and Efficacy of Exclusive Breastfeeding Promotion in the Era of HIV in Sub-Saharan Africa

Start date: November 2006
Phase: N/A
Study type: Interventional

The objective of the project is to develop and test an intervention to promote exclusive breastfeeding (EBF), to assess its impact on infant health in African contexts where a high prevalence of HIV is a barrier, and to strengthen the evidence base regarding the optimal duration for EBF. Promotion of EBF is the most effective child health intervention currently feasible for implementation at the population level in low-income countries. It can lower infant mortality by 13%, and by an additional 2% were it not for the fact that breastfeeding transmits HIV. Only recently proven to be possible in hot and even dry climates, EBF without even offering water is still little appreciated by mothers or supported by health workers. EBF rates are especially low in Africa but the potential for rapid implementation may be high. A few studies elsewhere suggest that peer counselling can often achieve dramatic increases. Thus the investigators will run the first randomised trial to develop and test models for applying this approach in four African countries and to quantify health benefits, cost-effectiveness, and implications for the health care system. While experts realize that the HIV threat ought not to present much of a biological constraint to promoting EBF, in heavily affected countries it does represent a cultural constraint. Overcoming this will require the development of a safe and effective means of promoting EBF that is HIV-sensitive by taking into account the need to minimise postnatal HIV transmission. Another scientific constraint to the promotion of exclusive breastfeeding for six months, as recommended by the World Health Organization (WHO), is uncertainty about its impact on the micronutrient status of infants. In a substudy, the investigators will carefully follow markers of infant micronutrient status to see how they vary by feeding pattern, including EBF, for a longer period than has been examined previously.

NCT ID: NCT00393679 Completed - Malaria Clinical Trials

Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children

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

The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations (ACT) [amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) and chlorproguanil/dapsone plus artesunate] for single and repeat treatments of uncomplicated malaria in children. Safety will be determined by registering adverse events and grading, laboratory, and vital signs evaluations. Their incidence will be compared between the different study arms. TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities. The leading EC approved the amendment on 2nd June 2008. TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.

NCT ID: NCT00373100 Completed - Pneumonia Clinical Trials

The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children

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

Pneumonia is a leading cause of morbidity and mortality in children in developing countries. Zinc deficiency leads to impairment in tissue repair and immunodeficiency in children.At least two randomised controlled trials have shown that zinc supplementation improves the outcome of severe pneumonia in children (reducing duration of hospital stay and complications related to pneumonia). However, there are conflicting results from other randomised controlled trials about its efficacy in children with pneumonia.The purpose of the current study is to determine the efficacy of zinc as adjunct therapy for in severe pneumonia in children aged 6-59 months. We hypothesize that the proportion of children who recover from severe pneumonia following zinc adjunct therapy [(10 mg once daily for seven days) for children aged <12 months and 20 mg daily for children aged ≥12 months]will be higher than the proportion of children who recover from placebo therapy.

NCT ID: NCT00372541 Completed - Pneumonia Clinical Trials

Ceftriaxone Versus Chloramphenicol for Treatment of Severe Pneumonia in Children

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

Acute lower respiratory tract infections are a leading cause of morbidity and mortality in sub Saharan Africa. The World Health Organisation (WHO) still recommends intravenous chloramphenicol for the treatment of severe pneumonia in children aged less than five years. However, up to 20% of children fail treatment due to the emergence of resistance by bacteria. Several centers now use ceftriaxone, a third generation cephalosporin, which is reported to be efficacious in the treatment of severe pneumonia. However the high cost of ceftriaxone is too prohibitive to allow for its routine use in resource constrained countries. The purpose of this study is to compare chloramphenicol and ceftriaxone in the treatment of severe pneumonia in children under five. We hypothesize that 92.7% of children who receive once daily intravenous ceftriaxone (75 mg/kg body weight)for 7 days, will recover from severe pneumonia compared to 80.2 % of those who receive intravenous chloramphenicol (25mg/kg body weight/dose every 6 hours for 7 days).

NCT ID: NCT00356824 Completed - HIV Infections Clinical Trials

Relationship Between HIV and Malaria in Ugandan Children

Start date: November 2005
Phase:
Study type: Observational

HIV and malaria are two of the most important diseases to afflict children in sub-Saharan Africa. However, it is unknown what relationships exist between the two diseases. The purpose of this study is to determine the relationship between HIV and malaria infections in HIV infected Ugandan children.