Can Presumptive Anthelminthic Treatment Delay the Progression of HIV in ART-naïve Patients in Rural Africa?

February 15, 2011 updated by: Swiss Tropical & Public Health Institute

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

* 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.

  • Objective: To assess the impact of presumptive anthelminthic treatment on HIV progression in patients infected with HIV in a rural setting with presumed high prevalence of helminth infection.
  • Methods: Randomised open-label trial of presumptive triple anthelminthic treatment in HIV positive patients not yet requiring anti-retroviral treatment.

Study Type

Interventional

Enrollment (Actual)

295

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
    • Kilombero
      • Ifakara, Kilombero, Tanzania, P.O. Box 53
        • Chronic Disease Clinic of St. Francis Designated District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HIV-positive patients
  • most recent CD4-count > 250 c/μl (latest within the previous 7 months)
  • anti-retroviral treatment naïve
  • age >18 years
  • provide written informed consent

Exclusion Criteria:

  • Pregnant and lactating women in the first week of lactation
  • Symptoms of severe anemia (or haemoglobin <5g/dl within the precious 3 months)
  • Symptoms of chronic diarrhea (defined as >= 3 stools per day of loose consistency for more than 2 weeks)
  • Patients on treatment for tuberculosis
  • WHO clinical stage 3 disease and CD4-count <350 c/μl
  • WHO clinical stage 4 disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: anthelminthic treatment
Albendazol plus fix-dose Praziquantel plus Ivermectin
Drug: Praziquantel, Ivermectin, Albendazole

Standard HIV care plus triple anthelminthic treatment

  • Praziquantel 2400mg single dose
  • Ivermectin 12 mg, single dose
  • Albendazole 400mg, 2 doses in 1 day

All drugs given at baseline, after 6 months and after 12 months.
No Intervention: HIV care, no anthelminthic treatment
HIV care as per Tanzanian National AIDS Control Program (NACP) guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in HIV viral load between intervention and control arm
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in CD4 counts between intervention and control arm
Time Frame: one year
one year
Difference in time to meet criteria for the initiation of anti-retroviral treatment
Time Frame: one year
one year
occurrence of severe adverse events
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Tropical & Public Health Institute

Collaborators

Merck KGaA, Darmstadt, Germany
University Hospital Inselspital, Berne
Ifakara Health Research and Development Centre

Investigators

  • Principal Investigator: Cornelia J. Staehelin, MD, Swiss Tropical Institute, Ifakara Health Institute
  • Study Director: Christoph F. Hatz, MD, Prof., Swiss Tropical & Public Health 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
  • Principal Investigator: Baraka Amuri, MD, Ifakara Health Institute
  • Study Chair: Salim Hamis, MD, Ifakara Health Institute
  • Study Chair: Juerg Utzinger, Prof., Swiss Tropical & Public Health Institute
  • Study Chair: Erik Mossdorf, MD, Swiss Tropical & Public Health Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 5, 2009

First Submitted That Met QC Criteria

January 5, 2009

First Posted (Estimate)

January 6, 2009

Study Record Updates

Last Update Posted (Estimate)

February 16, 2011

Last Update Submitted That Met QC Criteria

February 15, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 257/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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