Clinical Trials Directory

Trials / Completed

CompletedNCT00499876

The Effect of Malaria on Disease Progression of HIV/AIDS

The Effect of Malaria on Disease Progression of HIV/AIDS in Kumasi, Ghana

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
197 (actual)
Sponsor
London School of Hygiene and Tropical Medicine · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to find out whether malaria affects how HIV/AIDS disease progresses in an infected patient, and to determine the effect of reducing malaria infection on HIV disease progression in Kumasi

Detailed description

Malaria and HIV are among the most prevalent infectious diseases in sub-Saharan Africa and are major causes of morbidity and mortality in the sub region. Because of the wide-spread geographical overlap in HIV and malaria, the probability for co-infections and the potential for interactions between the two diseases are high. Even modest interactions may have substantial impact in populations. It is now clear that there are interactions between the two infections. HIV associated immunosuppression erodes the malaria acquired immunity of the HIV patients. The risk of parasitaemia, high parasite density and malarial fever increases with decreasing CD4 T cell counts and increasing viral load of HIV patients. Plasmodium falciparum has been shown to stimulate HIV replication through the production of cytokines (including interleukin 6 and tumor necrosing factor α (TNF-α)) by activated lymphocytes. Malaria treatment in HIV patients with malaria resulted in significant reduction of the median HIV viral load concentration. Although it is now clear that malaria causes transient rises in HIV-1 viral loads, could repeated episodes of malaria in areas of intense transmission lead to a cumulative effect on viral load and accelerate decline in CD4 counts thereby accelerating HIV disease progression? If so, could the decline in CD4 count in individuals who have not yet started on anti-retroviral drugs be slowed down by intermittent malaria treatment? A controlled interventional study with mefloquine as malaria prophylaxis for 6 months will be used in HIV/AIDS patients who are not already on ARTs in KATH, and malaria parasitaemia and density, HIV viral load and CD4 cell count will be monitored in both arms. Comparison: Malaria parasitaemia and density, HIV viral loads and CD4 cell counts will be compared between the intervention group and the control groups to determine the effect o malaria and malaria prophylaxis on HIV disease progression

Conditions

Interventions

TypeNameDescription
DRUGmefloquine250mg weekly PO for 6 months
OTHERplacebo1 tablet weekly PO for 6 months

Timeline

Start date
2007-10-01
Primary completion
2008-10-01
Completion
2009-12-01
First posted
2007-07-12
Last updated
2017-01-26

Locations

1 site across 1 country: Ghana

Source: ClinicalTrials.gov record NCT00499876. Inclusion in this directory is not an endorsement.