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

NCT00817713 | Terminated

• 1 other identifier: 257/08
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Human Immunodeficiency Virus; Helminthiasis; treatment naive; co-infection; immune modulation

Outcome Measures

Primary Outcomes (1)

• Difference in HIV viral load between intervention and control arm

  one year

Secondary Outcomes (3)

• Difference in CD4 counts between intervention and control arm

  one year

• Difference in time to meet criteria for the initiation of anti-retroviral treatment

  one year

• occurrence of severe adverse events

  one year

Study Arms (2)

anthelminthic treatment

ACTIVE COMPARATOR

Albendazol plus fix-dose Praziquantel plus Ivermectin

Drug: Praziquantel, Ivermectin, Albendazole

HIV care, no anthelminthic treatment

NO INTERVENTION

HIV care as per Tanzanian National AIDS Control Program (NACP) guidelines

Interventions

Praziquantel, Ivermectin, Albendazole DRUG

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.

anthelminthic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Ifakara Health Research and Development Centre: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (1)

Chronic Disease Clinic of St. Francis Designated District Hospital

Ifakara, Kilombero, P.O. Box 53, Tanzania

Location

Related Publications (10)

• Walson JL, John-Stewart G. Treatment of helminth co-infection in HIV-1 infected individuals in resource-limited settings. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006419. doi: 10.1002/14651858.CD006419.pub2.

  PMID: 18254104 BACKGROUND

• Walson JL, Otieno PA, Mbuchi M, Richardson BA, Lohman-Payne B, Macharia SW, Overbaugh J, Berkley J, Sanders EJ, Chung MH, John-Stewart GC. Albendazole treatment of HIV-1 and helminth co-infection: a randomized, double-blind, placebo-controlled trial. AIDS. 2008 Aug 20;22(13):1601-9. doi: 10.1097/QAD.0b013e32830a502e.

  PMID: 18670219 BACKGROUND

• Gupta SB, Jacobson LP, Margolick JB, Rinaldo CR, Phair JP, Jamieson BD, Mehrotra DV, Robertson MN, Straus WL. Estimating the benefit of an HIV-1 vaccine that reduces viral load set point. J Infect Dis. 2007 Feb 15;195(4):546-50. doi: 10.1086/510909. Epub 2007 Jan 5.

  PMID: 17230414 BACKGROUND

• Mohammed KA, Haji HJ, Gabrielli AF, Mubila L, Biswas G, Chitsulo L, Bradley MH, Engels D, Savioli L, Molyneux DH. Triple co-administration of ivermectin, albendazole and praziquantel in zanzibar: a safety study. PLoS Negl Trop Dis. 2008 Jan 23;2(1):e171. doi: 10.1371/journal.pntd.0000171.

  PMID: 18235853 BACKGROUND

• Brown M, Mawa PA, Kaleebu P, Elliott AM. Helminths and HIV infection: epidemiological observations on immunological hypotheses. Parasite Immunol. 2006 Nov;28(11):613-23. doi: 10.1111/j.1365-3024.2006.00904.x.

  PMID: 17042933 BACKGROUND

• Kallestrup P, Zinyama R, Gomo E, Butterworth AE, Mudenge B, van Dam GJ, Gerstoft J, Erikstrup C, Ullum H. Schistosomiasis and HIV-1 infection in rural Zimbabwe: effect of treatment of schistosomiasis on CD4 cell count and plasma HIV-1 RNA load. J Infect Dis. 2005 Dec 1;192(11):1956-61. doi: 10.1086/497696. Epub 2005 Oct 20.

  PMID: 16267767 BACKGROUND

• Brown M, Kizza M, Watera C, Quigley MA, Rowland S, Hughes P, Whitworth JA, Elliott AM. Helminth infection is not associated with faster progression of HIV disease in coinfected adults in Uganda. J Infect Dis. 2004 Nov 15;190(10):1869-79. doi: 10.1086/425042. Epub 2004 Oct 20.

  PMID: 15499545 BACKGROUND

• Elliott AM, Mawa PA, Joseph S, Namujju PB, Kizza M, Nakiyingi JS, Watera C, Dunne DW, Whitworth JA. Associations between helminth infection and CD4+ T cell count, viral load and cytokine responses in HIV-1-infected Ugandan adults. Trans R Soc Trop Med Hyg. 2003 Jan-Feb;97(1):103-8. doi: 10.1016/s0035-9203(03)90040-x.

  PMID: 12886815 BACKGROUND

• Modjarrad K, Zulu I, Redden DT, Njobvu L, Lane HC, Bentwich Z, Vermund SH. Treatment of intestinal helminths does not reduce plasma concentrations of HIV-1 RNA in coinfected Zambian adults. J Infect Dis. 2005 Oct 1;192(7):1277-83. doi: 10.1086/444543. Epub 2005 Aug 25.

  PMID: 16136473 BACKGROUND

• Wolday D, Mayaan S, Mariam ZG, Berhe N, Seboxa T, Britton S, Galai N, Landay A, Bentwich Z. Treatment of intestinal worms is associated with decreased HIV plasma viral load. J Acquir Immune Defic Syndr. 2002 Sep 1;31(1):56-62. doi: 10.1097/00126334-200209010-00008.

  PMID: 12352151 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Helminthiasis; Acquired Immunodeficiency Syndrome; Coinfection

Interventions

Praziquantel; Ivermectin; Albendazole

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Parasitic Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Macrolides; Polyketides; Lactones; Organic Chemicals; Carbamates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles

Study Officials

• Cornelia J. Staehelin, MD

  Swiss Tropical Institute, Ifakara Health Institute

  PRINCIPAL INVESTIGATOR

• Christoph F. Hatz, MD, Prof.

  Swiss Tropical & Public Health Institute

  STUDY DIRECTOR

• Hansjakob Furrer, MD, Prof.

  Infectious Disease Unit, Inselspital, University Hospital Berne, 3010 Berne, Switzerland

  STUDY CHAIR

• Honorathy Urassa, MSc

  Ifakara Health Institute

  STUDY CHAIR

• Baraka Amuri, MD

  Ifakara Health Institute

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 16, 2011

Record last verified: 2009-04

Locations

TA (1)