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NCT ID: NCT00158483 Completed - Ulcer Clinical Trials

Anti-Herpetic Treatment of Genital Ulcer : Effect on HIV & Herpes Shedding (ANRS 1212)

Start date: May 2003
Phase: Phase 2
Study type: Interventional

Herpes virus type 2 (HSV-2) infection - as a cofactor of human immunodeficiency virus (HIV) transmission - can be targeted by anti-herpetic specific drugs, either as a continuous prophylactic treatment during its asymptomatic shedding phase, or as an episodic treatment during clinically-apparent genital ulcerations. The main objective of this trial will be to demonstrate that acyclovir treatment given during clinical episodes (primary infection or recurrences) can reduce genital shedding of HIV, thereby contributing to a reduction of HIV infectiousness of dually infected individuals (HIV+/HSV+).

NCT ID: NCT00146783 Completed - Malaria Clinical Trials

Navrongo Drug Options for IPT in Pregnancy Trial

Start date: June 2004
Phase: Phase 2/Phase 3
Study type: Interventional

In areas of stable transmission, pregnant women, especially during the first and second pregnancies, have an increased susceptibility to Plasmodium falciparum malaria, malaria-related anaemia and an increased risk of having low birthweight babies. Intermittent Preventive Treatment in pregnancy(IPTp) with sulphadoxine-pyrimethamine has been shown to be effective in reducing the effects of malaria in pregnancy. This has mainly been in areas of perennial transmission and there is a need to study this effect in intense seasonal transmission settings. The emergence and spread of resistance to SP is likely to undermine its useful lifespan and it is important that other antimalarials that are safe and effective are identified for use in IPTp. The options are however limited. Amodiaquine has been shown to be effective in treatment of clinical cases of malaria, even in areas where chloroquine resistance is prevalent, and its combination with SP has been associated with favourable results. Both are affordable. However, there is limited data on their use in pregnancy. This study aims to assess the efficacy of SP in an area of intense seasonal transmission, and evaluate the safety and efficacy of amodiaquine and a combination of sulphadoxine-pyrimethamine and amodiaquine as possible alternatives to SP for use as IPTp.

NCT ID: NCT00146692 Completed - Malaria Clinical Trials

A Trial of Improved Financial Access to Healthcare in Ghana

Start date: April 2004
Phase: Phase 4
Study type: Interventional

Effective control strategies for malaria depend both on preventing disease and on treating those who become infected to prevent significant morbidity and mortality. There are many barriers to preventing access to prompt and effective treatment, some of which are amenable to intervention, others (such as distance to healthcare) less so. This study will concentrate on modifiable financial barriers to care. With the aim of increasing health service utilization and reducing morbidity and mortality among children under five, some governments are currently implementing policies aimed at reducing financial barriers to health care. There is at the same time an on-going debate concerning the relative importance of cost as a barrier to health care. Though theoretically the aim for reducing these barriers should be achieved, its actual impact has not been directly assessed or demonstrated by means of an intervention trial. This study aims to determine by means of a randomized trial the impact of reducing such barriers on morbidity due to severe malaria among children 6 months to five years and on outpatient utilization. An existing pre-payment scheme in the study area will be utilized to improve financial access for half of 2500 households who have not registered for either year I or II. The impact on severe anaemia, mean haemoglobin and anthropometric measurements will be assessed. Health service utilisation rates will be measured in both groups by active and passive surveillance. Patient perceptions and health-seeking behaviour will be compared. The study will contribute to the current debate on the relative importance of cost of care as a barrier to health care and the potential for the removal of this barrier as a strategy for malaria control, and on methods to optimise this.

NCT ID: NCT00138307 Completed - Malaria Clinical Trials

Correlates of Protection in Ghana

Start date: n/a
Phase: N/A
Study type: Observational

Malaria is a sickness passed from one person to the other by the bite of a mosquito. In areas of frequent malaria infection, children may develop natural protection against malaria and they are less likely to become sick or die from it as they age. The purpose of this study is to investigate the body's natural protection against malaria in children by testing their blood. This information may help investigators develop a malaria vaccine. The Navrongo Health Research Centre is conducting this study in Ghana. Three hundred healthy children between the ages of 1 and 5 years will participate in the study for 12 months. Study procedures will include 7 field worker visits to check on the child's health and obtain a blood sample. Every two months, a blood sample will be taken from each child to test it for strength against malaria. Whenever a child is sick, the child will be tested for malaria.

NCT ID: NCT00129532 Active, not recruiting - HIV Infections Clinical Trials

Trial of SAVVY and HIV in Ghana

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

Heterosexual contact is now the primary route of transmission for HIV worldwide. This study is a phase 3 trial designed to determine the effectiveness and safety of the 1.0% C31G (SAVVY) vaginal gel for the prevention of male-to-female transmission of HIV among women at high risk.

NCT ID: NCT00122486 Completed - HIV Infections Clinical Trials

Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV

Start date: July 2004
Phase: Phase 2
Study type: Interventional

This Phase 2 study involving tenofovir disoproxil fumarate (TDF) will assess the extended safety of TDF 300 mg per day among young women who are not HIV-infected.

NCT ID: NCT00119145 Completed - Malaria Clinical Trials

Kintampo Trial of Combination Therapy for Malaria

Start date: June 2005
Phase: Phase 4
Study type: Interventional

Case management is one of the key strategies for malaria control in most endemic countries. Plasmodium falciparum malaria is becoming resistant to commonly used and cheap antimalarial drugs such as chloroquine, amodiaquine, and sulfadoxine-pyrimethamine (SP). Thus the safety and efficacy of new anti-malarial drugs need to be tested in sites with well-characterised malariometric indices in order to make appropriate treatment policies. Artemisinin-based combination chemotherapies have been documented to consistently produce faster relief of clinical symptoms and parasite clearance in uncomplicated falciparum malaria than any other currently used antimalarial drugs. So far, artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AR-LM) are the only two registered fixed-dose artemisinin combination chemotherapies produced at industrial scale, with good manufacturing practices and already used in Africa. Several African countries, including Ghana, are therefore introducing either AS-AQ or AR-LM as first-line antimalarials or evaluating the case for such a change. Clearly, a direct comparison of both the safety and efficacy profiles of the two combinations under different epidemiological conditions is urgently needed to guide informed decisions on the most appropriate antimalarial first-line treatment regimen. This study aims to evaluate the efficacy and safety of artesunate-amodiaquine combination therapy, artemether-lumefantrine, and artesunate-lapdap in an open-labelled, randomised, non-inferiority drug trial. The study results will inform future decisions on first- and second-line treatments for uncomplicated P. falciparum malaria with respect to efficacy and safety in Ghana.

NCT ID: NCT00119132 Completed - Malaria Clinical Trials

Effectiveness of Intermittent Preventive Treatment for Malaria in Children

Start date: June 2005
Phase: Phase 2/Phase 3
Study type: Interventional

Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.

NCT ID: NCT00082576 Completed - Malaria, Falciparum Clinical Trials

Azithromycin Plus Chloroquine Versus Mefloquine for the Treatment of Uncomplicated Malaria in Africa

Start date: June 2004
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to mefloquine for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.