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

NCT00817713 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2011-02-16

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections
  • Helminthiasis

Interventions

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.

Sponsors & Collaborators

  • Ifakara Health Research and Development Centre

    collaborator OTHER
  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER
  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY
  • Swiss Tropical & Public Health Institute

    lead OTHER

Principal Investigators

  • Cornelia J. Staehelin, MD · Swiss Tropical Institute, Ifakara Health Institute

  • Christoph F. Hatz, MD, Prof. · Swiss Tropical & Public Health Institute

  • Hansjakob Furrer, MD, Prof. · Infectious Disease Unit, Inselspital, University Hospital Berne, 3010 Berne, Switzerland

  • Honorathy Urassa, MSc · Ifakara Health Institute

  • Baraka Amuri, MD · Ifakara Health Institute

  • Salim Hamis, MD · Ifakara Health Institute

  • Juerg Utzinger, Prof. · Swiss Tropical & Public Health Institute

  • Erik Mossdorf, MD · Swiss Tropical & Public Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Tanzania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00817713 on ClinicalTrials.gov