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

Sponsor:	University of Washington
Collaborators:	Kenya Medical Research Institute University of Nairobi Kenyatta Hospital
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00130910

Purpose

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.

Condition	Intervention
HIV Infections Helminthiasis	Drug: Albendazole Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Double Blind, Placebo Controlled Trial of Albendazole in Soil-Transmitted Helminth and HIV-1 co-Infected Kenyan Individuals to Determine the Effect of Such Treatment on HIV-1 Disease Progression and Genital Shedding.

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Albendazole

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Change in markers of HIV-1 disease progression [ Time Frame: 12 weeks ]
CD4 count [ Time Frame: 12 weeks ]
HIV-1 RNA level [ Time Frame: 12 weeks ]
Genital HIV-1 RNA levels [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

Immune activation markers of global T cell activation [ Time Frame: 12 weeks ]
Numbers of CD4+ and CD8+ T cells expressing Ki67 [ Time Frame: 12 weeks ]
Naïve and memory T cell subsets [ Time Frame: 12 weeks ]
Type and number of helminth co-infections [ Time Frame: 12 weeks ]

Enrollment:	234
Study Start Date:	March 2006
Study Completion Date:	June 2007

Arms	Assigned Interventions
1: Experimental Albendazole	Drug: Albendazole Albendazole 400mg x 3 first dose observed
2: Placebo Comparator	Drug: Placebo Albendazole Placebo 400mg x 3 first dose observed

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130910

Locations

Kenya
Kenya Medical Research Institute
Nairobi, Kenya

Sponsors and Collaborators

University of Washington

Kenya Medical Research Institute

University of Nairobi

Kenyatta Hospital

Investigators

Study Director:	Judd L Walson, MD, MPH	University of Washington
Principal Investigator:	Grace C. John-Stewart, MD, PhD, MPH	University of Washington

More Information

Additional Information:

University of Washington IRB This link exits the ClinicalTrials.gov site

University of Washington Royalty Research Fund This link exits the ClinicalTrials.gov site

Publications:

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

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.

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.

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.

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.

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.

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.

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.

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.

Bennett A, Guyatt H. Reducing intestinal nematode infection: efficacy of albendazole and mebendazole. Parasitol Today. 2000 Feb;16(2):71-4. Review.

Study ID Numbers:	06-1127-D03, NIH 5 P30 AI027757-19, UW Royalty Research Fund #3335
Study First Received:	August 12, 2005
Last Updated:	November 13, 2007
ClinicalTrials.gov Identifier:	NCT00130910 History of Changes
Health Authority:	United States: Institutional Review Board; Kenya: Ministry of Health

Keywords provided by University of Washington:

HIV
Helminthiasis
Co-infection
Intestinal immune activation
Treatment Naive

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Antiprotozoal Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Infection
Albendazole
Antiparasitic Agents
Therapeutic Uses
Parasitic Diseases
Retroviridae Infections
Helminthiasis
RNA Virus Infections

Immune System Diseases
Antiplatyhelmintic Agents
Mitosis Modulators
Acquired Immunodeficiency Syndrome
Anthelmintics
Antimitotic Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Anticestodal Agents
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Tubulin Modulators
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010