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
  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 Infections
Helminthiasis
Drug: Praziquantel, Ivermectin, Albendazole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Swiss Tropical & Public Health Institute:

Primary Outcome Measures:
  • Difference in HIV viral load between intervention and control arm [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 295
Study Start Date: January 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817713

Locations
Tanzania
Chronic Disease Clinic of St. Francis Designated District Hospital
Ifakara, Kilombero, Tanzania, P.O. Box 53
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Ifakara Health Research and Development Centre
University Hospital Inselspital, Berne
Merck KGaA
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
  More Information

Publications:

Responsible Party: Cornelia Staehelin, MD, Swiss Tropical Institute
ClinicalTrials.gov Identifier: NCT00817713     History of Changes
Other Study ID Numbers: 257/08
Study First Received: January 5, 2009
Last Updated: February 15, 2011
Health Authority: Tanzania: National Institute for Medical Research

Keywords provided by Swiss Tropical & Public Health Institute:
Human Immunodeficiency Virus
Helminthiasis
treatment naive
co-infection
immune modulation

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Communicable Diseases
Disease Progression
Helminthiasis
Infection
Disease Attributes
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Parasitic Diseases
Pathologic Processes
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Albendazole
Anthelmintics
Ivermectin
Praziquantel
Anti-Infective Agents
Anticestodal Agents
Antimitotic Agents
Antineoplastic Agents
Antiparasitic Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on October 28, 2014