The Effect of Malaria on Disease Progression of HIV/AIDS
Recruitment status was Active, not recruiting
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Purpose
| Condition | Intervention |
|---|---|
|
HIV Infections Malaria |
Drug: mefloquine Other: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | The Effect of Malaria on Disease Progression of HIV/AIDS in Kumasi, Ghana |
- 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 effect of malaria prophylaxis on malaria parasitaemia and haemoglobin levels in study patients [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 197 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | March 2009 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A |
Drug: mefloquine
250mg weekly PO for 6 months
|
| Placebo Comparator: B |
Other: placebo
1 tablet weekly PO for 6 months
|
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
Eligibility| Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00499876
| Ghana | |
| Komfo Anokye Teaching Hospital | |
| Kumasi, Ghana, 1934 | |
| Principal Investigator: | Ruby Martin-Peprah, MBChB, PhD | Komfo Anokye Teaching Hospital |
More Information
| Responsible Party: | Dr Ruby Martin-Peprah, Komfo Anokye teaching Hospital |
| ClinicalTrials.gov Identifier: | NCT00499876 History of Changes |
| Other Study ID Numbers: | REG_9 KATH_GMP_1 |
| Study First Received: | July 11, 2007 |
| Last Updated: | March 5, 2009 |
| Health Authority: | Ghana: Ministry of Health |
Keywords provided by Gates Malaria Partnership:
|
Human immune deficiency virus Acquired immune deficiency syndrome malaria mefloquine |
prophylaxis HIV/AIDS Treatment Naive |
Additional relevant MeSH terms:
|
HIV Infections Malaria Disease Progression Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Protozoan Infections Parasitic Diseases Disease Attributes Pathologic Processes Mefloquine Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 26, 2016