Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373048
Status:
COMPLETED
Last Update Posted:
2011-05-24
First Post:
2006-09-05
Brief Title:
Mefloquine Prophylaxis in HIV-1 Individuals a Randomized Placebo-controlled Trial
Sponsor:
Institute of Tropical Medicine Belgium
Organization:
Institute of Tropical Medicine Belgium
Study Overview
Official Title:
Mefloquine Malaria Prophylaxis in HIV-1 Infected Individuals and Its Influence on the Evolution Towards AIDS a Randomized Placebo-controlled Trial
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized placebo controlled trial Malaria chemoprophylaxis with mefloquine in asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya Zambia will be compared to a placebo control group and followed up for 18 months
Detailed Description:
In Zambia prompt treatment of malaria cases is the mainstay of malaria control antimalarial chemoprophylaxis is not currently recommended for general use so that the use of placebo as a comparator in this study is justified We will analyse safety and efficacy of mefloquine malaria and AIDS related parameters at predefined time points and verify if this intervention could produce a slower decrease in CD4 counts compared to passive case management of malaria
This is a randomized placebo controlled trial Malaria chemoprophylaxis with mefloquine in asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya Zambia will be compared to a placebo control group and followed up for 18 months
Specific designed studies taking into account possible confounding parameters and interactions are needed to measure the impact of malaria control in an HIV endemic environment In particular the question should be answered if malaria control has an impact on the disease progression of HIV The possible impact of these interventions on morbidity and mortality taking into account these parameters might have a major public health impact This might be on the use of antiretroviral drugs the incidence of clinical eventually severe malaria and spread of antimalarial resistance through immune compromised HIV patients with and without antimalarial treatment
Studies of alternative strategies that contribute next to antiretrovirals to the control and prevention of HIV pandemic are equally important and urgently needed The need to design these strategies is critical given the high incidence of malaria and HIV in countries in Sub Saharan Africa such as Zambia and its serious impact on survival and the socio-economic situation Moreover a cost-benefit analysis might show that some alternative strategies have a major impact on the field with less technical financial and social constraints than the strategies recommended so far
All HIVP patients will be treated for opportunistic infections OI and receive antiretroviral drugs following the National guidelines on Management and Care of Patients with HIVAIDS also if this occurs after the study period At the time they need cotrimoxazole prevention orand receive antiretrovirals they would have reached a study endpoint and will be excluded from the trial though the follow up will continue
This is a randomized placebo controlled trial Malaria chemoprophylaxis with mefloquine in asymptomatic HIV-infected adults living in a malaria endemic region of Luanshya Zambia will be compared to a placebo control group and followed up for 18 months
Specific designed studies taking into account possible confounding parameters and interactions are needed to measure the impact of malaria control in an HIV endemic environment In particular the question should be answered if malaria control has an impact on the disease progression of HIV The possible impact of these interventions on morbidity and mortality taking into account these parameters might have a major public health impact This might be on the use of antiretroviral drugs the incidence of clinical eventually severe malaria and spread of antimalarial resistance through immune compromised HIV patients with and without antimalarial treatment
Studies of alternative strategies that contribute next to antiretrovirals to the control and prevention of HIV pandemic are equally important and urgently needed The need to design these strategies is critical given the high incidence of malaria and HIV in countries in Sub Saharan Africa such as Zambia and its serious impact on survival and the socio-economic situation Moreover a cost-benefit analysis might show that some alternative strategies have a major impact on the field with less technical financial and social constraints than the strategies recommended so far
All HIVP patients will be treated for opportunistic infections OI and receive antiretroviral drugs following the National guidelines on Management and Care of Patients with HIVAIDS also if this occurs after the study period At the time they need cotrimoxazole prevention orand receive antiretrovirals they would have reached a study endpoint and will be excluded from the trial though the follow up will continue
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None