The Effect of Malaria on Disease Progression of HIV/AIDS
Primary Purpose
HIV Infections, Malaria
Status
Completed
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
mefloquine
placebo
Sponsored by
About this trial
This is an interventional supportive care trial for HIV Infections focused on measuring Human immune deficiency virus, Acquired immune deficiency syndrome, malaria, mefloquine, prophylaxis, HIV/AIDS, Treatment Naive
Eligibility Criteria
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
Sites / Locations
- Komfo Anokye Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Measure the effects of antimalarials on CD4 cell count decline and HIV viral load increase in study patients
Secondary Outcome Measures
Measure the effect of malaria prophylaxis on malaria parasitaemia and haemoglobin levels in study patients
Full Information
NCT ID
NCT00499876
First Posted
July 11, 2007
Last Updated
January 25, 2017
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Noguchi Memorial Institute for Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT00499876
Brief Title
The Effect of Malaria on Disease Progression of HIV/AIDS
Official Title
The Effect of Malaria on Disease Progression of HIV/AIDS in Kumasi, Ghana
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Noguchi Memorial Institute for Medical Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Malaria
Keywords
Human immune deficiency virus, Acquired immune deficiency syndrome, malaria, mefloquine, prophylaxis, HIV/AIDS, Treatment Naive
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
mefloquine
Intervention Description
250mg weekly PO for 6 months
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
1 tablet weekly PO for 6 months
Primary Outcome Measure Information:
Title
Measure the effects of antimalarials on CD4 cell count decline and HIV viral load increase in study patients
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Measure the effect of malaria prophylaxis on malaria parasitaemia and haemoglobin levels in study patients
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruby Martin-Peprah, MBChB, PhD
Organizational Affiliation
Komfo Anokye Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Komfo Anokye Teaching Hospital
City
Kumasi
ZIP/Postal Code
1934
Country
Ghana
12. IPD Sharing Statement
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The Effect of Malaria on Disease Progression of HIV/AIDS
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