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

This study has been terminated.
(Terminated prematurely due to recruitment difficulties. Expansion to more study sites not planned.)
Sponsor:
Collaborators:
Ifakara Health Research and Development Centre
University Hospital Inselspital, Berne
Merck KGaA
Information provided by:
Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:
NCT00817713
First received: January 5, 2009
Last updated: February 15, 2011
Last verified: April 2009

January 5, 2009
February 15, 2011
January 2009
September 2010   (final data collection date for primary outcome measure)
Difference in HIV viral load between intervention and control arm [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00817713 on ClinicalTrials.gov Archive Site
  • Difference in CD4 counts between intervention and control arm [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Difference in time to meet criteria for the initiation of anti-retroviral treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
  • occurrence of severe adverse events [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Can Presumptive Anthelminthic Treatment Delay the Progression of HIV in ART-naïve Patients in Rural Africa?
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.

* 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Helminthiasis
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.

  • Active Comparator: anthelminthic treatment
    Albendazol plus fix-dose Praziquantel plus Ivermectin
    Intervention: Drug: Praziquantel, Ivermectin, Albendazole
  • No Intervention: HIV care, no anthelminthic treatment
    HIV care as per Tanzanian National AIDS Control Program (NACP) guidelines

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
295
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT00817713
257/08
No
Cornelia Staehelin, MD, Swiss Tropical Institute
Swiss Tropical & Public Health Institute
  • Ifakara Health Research and Development Centre
  • University Hospital Inselspital, Berne
  • Merck KGaA
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
Swiss Tropical & Public Health Institute
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP