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| Sponsor: | Swiss Tropical Institute |
|---|---|
| Collaborators: |
Ifakara Health Research and Development Centre University Hospital Inselspital, Berne Merck KGaA |
| Information provided by: | Swiss Tropical Institute |
| ClinicalTrials.gov Identifier: | NCT00817713 |
Purpose
This study focuses on one of the major health issues of Sub-Saharan Africa: multi-parasitism and co-infections. In particular this study aims to elucidate the interaction of helminths with HIV.
There is good reason to suspect a detrimental effect of helminth infection on the course of HIV infection. We hypothesize, that treatment of helminths in HIV- and helminth co-infected individuals leads to a reduction of HIV viral load. With a lower HIV RNA level one would expect a slower decline of CD4 cells and hence also a slower progression of the disease. Ideally this would lead to a prolongation of the chronic phase of HIV infection and to a delay in the time when anti-retroviral treatment needs to be started.
| Condition | Intervention |
|---|---|
|
HIV Helminthiasis HIV Infections |
Drug: Praziquantel, Ivermectin, Albendazole |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Can Anthelminthic Treatment Delay the Progression of HIV? Randomised Open-Label Trial Testing Presumptive Anthelminthic Treatment on Progression of HIV in ART-naïve HIV-Positive Patients in a Rural African Setting With Presumed High Prevalence of Helminth Infections. |
| Estimated Enrollment: | 672 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator |
Drug: Praziquantel, Ivermectin, Albendazole
Standard HIV care plus triple anthelminthic treatment
All drugs given at baseline, after 6 months and after 12 months. |
| 2: No Intervention |
* Background: On the basis of immunological considerations and in vitro trials on co-infections there is strong reason to suspect a detrimental effect of helminth infection on the course of HIV. The immunological answer very efficiently evoked by helminth infection is aimed at hijacking and suppressing the immune system in order to suit the requirements of the specific helminth. This permits helminths to cause chronic infection, often persisting over years and allowing some infecting worms to grow to several centimetres of length within their host. However, this immune modulation also affects non-related antigens (for example HIV) which would actually require a different line of immunological action.
Some clinical trials have been able to confirm this detrimental effect of helminths on HIV infection, while other trials failed to do so. A recent Cochrane review on clinical trials with HIV and helminth co-infection found an overall slight reduction of HIV viral load if helminth infection was treated. However there was no measurable effect on CD4 count or clinical staging of HIV. This might be explained by the fact that these trials were very heterogeneous in their set-up and were run for too short a time (max 6 months) to allow sufficient answers to these questions.
According to mathematical models, even a relatively modest reduction of HIV RNA by 0.5 log could delay the need to start combined antiretroviral therapy by about 3.5 years and potentially prolong the symptom-free phase of HIV-infection by nearly 1 year. On a population scale this could lead to substantial savings with regard to drug and clinical costs and on an individual level to an invaluable gain in drug-free and ideally also symptom-free life years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cornelia J. Staehelin, MD | 0255782417883 | c_staehelin@yahoo.com |
| Contact: Christoph F. Hatz, MD, Professor | +41 61 284 8255 | christoph.hatz@unibas.ch |
| Tanzania, Kilombero | |
| Chronic Disease Clinic of St. Francis Designated District Hospital | Recruiting |
| Ifakara, Kilombero, Tanzania, P.O. Box 53 | |
| Principal Investigator: | Cornelia J. Staehelin, MD | Swiss Tropical Institute, Ifakara Health Institute |
| Study Director: | Christoph F. Hatz, MD, Prof. | Swiss Tropical Institute |
| Study Chair: | Hansjakob Furrer, MD, Prof. | Infectious Disease Unit, Inselspital, University Hospital Berne, 3010 Berne, Switzerland |
| Study Chair: | Honorathy Urassa, MSc | Ifakara Health Institute |
| Study Chair: | Erik Mossdorf, MD | Swiss Tropical Institute, Ifakara Health Institute |
| Study Chair: | Juerg Utzinger, MSc, Prof | Swiss Tropical Institute |
More Information
| Responsible Party: | Swiss Tropical Institute ( Cornelia Staehelin, MD ) |
| Study ID Numbers: | 257/08 |
| Study First Received: | January 5, 2009 |
| Last Updated: | April 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00817713 History of Changes |
| Health Authority: | Tanzania: National Institute for Medical Research |
|
Human Immunodeficiency Virus Helminthiasis treatment naive |
|
Anti-Infective Agents Communicable Diseases Antiprotozoal Agents Sexually Transmitted Diseases, Viral Disease Attributes Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Disease Progression Infection Albendazole Antiparasitic Agents Pathologic Processes Ivermectin Therapeutic Uses |
Parasitic Diseases Praziquantel Retroviridae Infections Helminthiasis RNA Virus Infections Immune System Diseases Antiplatyhelmintic Agents Mitosis Modulators Acquired Immunodeficiency Syndrome Anthelmintics Antimitotic Agents Pharmacologic Actions Immunologic Deficiency Syndromes Anticestodal Agents Virus Diseases |
