The Effect of Malaria on Disease Progression of HIV/AIDS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Gates Malaria Partnership.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Noguchi Memorial Institute for Medical Research, University of Ghana
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00499876
First received: July 11, 2007
Last updated: March 5, 2009
Last verified: March 2009

July 11, 2007
March 5, 2009
October 2007
October 2008   (final data collection date for primary outcome measure)
Measure the effects of antimalarials on CD4 cell count decline and HIV viral load increase in study patients [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Measure the effects of antimalarials on CD4 cell count decline and HIV viral load increase in study patients [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00499876 on ClinicalTrials.gov Archive Site
Measure the effect of malaria prophylaxis on malaria parasitaemia and haemoglobin levels in study patients [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Measure the effect of malaria prophylaxis on malaria parasitaemia and haemoglobin levels in study patients [ Time Frame: 12 months ]
Not Provided
Not Provided
 
The Effect of Malaria on Disease Progression of HIV/AIDS
The Effect of Malaria on Disease Progression of HIV/AIDS in Kumasi, Ghana

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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • HIV Infections
  • Malaria
  • Drug: mefloquine
    250mg weekly PO for 6 months
  • Other: placebo
    1 tablet weekly PO for 6 months
  • Active Comparator: A
    Intervention: Drug: mefloquine
  • Placebo Comparator: B
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
197
March 2009
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult HIV patients attending the Komfo Anokye Teaching Hospital (KATH) HIV clinic who do not yet fulfil the criteria for ARTs. This includes a CD 4 cell count of ≥ 300x106/l and World Health Organisation HIV stage I-III

Exclusion Criteria:

  • All children with HIV infection attending the HIV clinic at KATH
  • Adult HIV patients on ARTs attending the HIV clinic at KATH
  • Adult HIV patients with WHO stage IV and V AIDS
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Ghana
 
NCT00499876
REG_9, KATH_GMP_1
Yes
Dr Ruby Martin-Peprah, Komfo Anokye teaching Hospital
Gates Malaria Partnership
Noguchi Memorial Institute for Medical Research, University of Ghana
Principal Investigator: Ruby Martin-Peprah, MBChB, PhD Komfo Anokye Teaching Hospital
Gates Malaria Partnership
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP