Treatment of Helminth co-Infection: Short-Term Effects on HIV-1 Progression Markers and Immune Activation

NCT00130910 | Completed

• 3 other identifiers: 06-1127-D03NIH 5 P30 AI027757-19UW Royalty Research Fund #3335
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

Identifying methods to slow disease progression in patients with HIV-1 infection remains a top priority in many regions of the world. In many countries, medications known to slow progression are not readily affordable or available. Many of the individuals living in these countries are also co-infected with a variety of other diseases such as tuberculosis, malaria and soil-transmitted helminths. There are data to suggest that infection with these agents may activate the immune system in HIV-1 co-infected individuals and may lead to more rapid HIV disease progression. This study will evaluate the potential impact of treating helminths in HIV-1 seropositive individuals. Markers of disease progression and immune activation will be assessed. We will also measure the amount of virus in genital secretions to determine if treatment of co-infection can reduce the infectiousness of HIV in these individuals.

Conditions

HIV Infections; Helminthiasis

Keywords

HIV; Helminthiasis; Co-infection; Intestinal immune activation; Treatment Naive

Outcome Measures

Primary Outcomes (4)

• Change in markers of HIV-1 disease progression

  12 weeks

• CD4 count

  12 weeks

• HIV-1 RNA level

  12 weeks

• Genital HIV-1 RNA levels

  12 weeks

Secondary Outcomes (4)

• Immune activation markers of global T cell activation

  12 weeks

• Numbers of CD4+ and CD8+ T cells expressing Ki67

  12 weeks

• Naïve and memory T cell subsets

  12 weeks

• Type and number of helminth co-infections

  12 weeks

Study Arms (2)

1

EXPERIMENTAL

Albendazole

Drug: Albendazole

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Albendazole DRUG

Albendazole 400mg x 3 first dose observed

Also known as: Zentel

1

Placebo DRUG

Albendazole Placebo 400mg x 3 first dose observed

2

Eligibility Criteria

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

You may qualify if:

• Participants must not be or have been on highly active antiretroviral therapy.
• Participants must have a CD4 count greater than 250 cells/mm3.
• Participants must be at least 18 years of age.
• Participants must be able and willing to participate and give written informed consent.
• Participants must be able and willing to return for the scheduled follow-up visits.
• In addition, in order to be included in the treatment phase of the study, patients must have at least one stool specimen positive for a soil transmitted helminth.

You may not qualify if:

• Participants who have received treatment for helminth infection in the past 6 months (by self report or chart review).
• Participants must not be pregnant at the time of treatment (by urine HCG testing).
• Participants who present with other serious co-morbidities such as severe anaemia, malaria or tuberculosis.

Sponsors & Collaborators

• University of Washington: lead
• Kenya Medical Research Institute: collaborator
• University of Nairobi: collaborator
• Kenyatta National Hospital: collaborator

Study Sites (1)

Kenya Medical Research Institute

Nairobi, Kenya

Location

Related Publications (12)

• 2004 report on the global AIDS epidemic : 4th global report. UNAIDS

  BACKGROUND

• Fincham JE, Markus MB, Adams VJ. Could control of soil-transmitted helminthic infection influence the HIV/AIDS pandemic. Acta Trop. 2003 May;86(2-3):315-33. doi: 10.1016/s0001-706x(03)00063-9.

  PMID: 12745148 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

• Bentwich Z, Weisman Z, Moroz C, Bar-Yehuda S, Kalinkovich A. Immune dysregulation in Ethiopian immigrants in Israel: relevance to helminth infections? Clin Exp Immunol. 1996 Feb;103(2):239-43. doi: 10.1046/j.1365-2249.1996.d01-612.x.

  PMID: 8565306 BACKGROUND

• Kassu A, Tsegaye A, Wolday D, Petros B, Aklilu M, Sanders EJ, Fontanet AL, Van Baarle D, Hamann D, De Wit TF. Role of incidental and/or cured intestinal parasitic infections on profile of CD4+ and CD8+ T cell subsets and activation status in HIV-1 infected and uninfected adult Ethiopians. Clin Exp Immunol. 2003 Apr;132(1):113-9. doi: 10.1046/j.1365-2249.2003.02106.x.

  PMID: 12653845 BACKGROUND

• Elliott AM, Kyosiimire J, Quigley MA, Nakiyingi J, Watera C, Brown M, Joseph S, French N, Gilks CF, Whitworth JA. Eosinophilia and progression to active tuberculosis in HIV-1-infected Ugandans. Trans R Soc Trop Med Hyg. 2003 Jul-Aug;97(4):477-80. doi: 10.1016/s0035-9203(03)90096-4.

  PMID: 15259486 BACKGROUND

• Olsen A. The proportion of helminth infections in a community in western Kenya which would be treated by mass chemotherapy of schoolchildren. Trans R Soc Trop Med Hyg. 1998 Mar-Apr;92(2):144-8. doi: 10.1016/s0035-9203(98)90721-0.

  PMID: 9764316 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

• Lawn SD, Karanja DM, Mwinzia P, Andove J, Colley DG, Folks TM, Secor WE. The effect of treatment of schistosomiasis on blood plasma HIV-1 RNA concentration in coinfected individuals. AIDS. 2000 Nov 10;14(16):2437-43. doi: 10.1097/00002030-200011100-00004.

  PMID: 11101053 BACKGROUND

• Bennett A, Guyatt H. Reducing intestinal nematode infection: efficacy of albendazole and mebendazole. Parasitol Today. 2000 Feb;16(2):71-4. doi: 10.1016/s0169-4758(99)01544-6.

  PMID: 10652492 BACKGROUND

• Walson JL, Stewart BT, Sangare L, Mbogo LW, Otieno PA, Piper BK, Richardson BA, John-Stewart G. Prevalence and correlates of helminth co-infection in Kenyan HIV-1 infected adults. PLoS Negl Trop Dis. 2010 Mar 30;4(3):e644. doi: 10.1371/journal.pntd.0000644.

  PMID: 20361031 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

HIV Infections; Helminthiasis; Coinfection

Interventions

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

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Judd L Walson, MD, MPH

  University of Washington

  STUDY DIRECTOR

• Grace C. John-Stewart, MD, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 16, 2005
• Study Start: March 1, 2006
• Study Completion: June 1, 2007
• Last Updated: November 15, 2007

Record last verified: 2007-11

Locations

KE (1)