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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00130910
Recruitment Status : Completed
First Posted : August 16, 2005
Last Update Posted : November 15, 2007
Kenya Medical Research Institute
University of Nairobi
Kenyatta National Hospital
Information provided by:
University of Washington

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.

Condition or disease Intervention/treatment Phase
HIV Infections Helminthiasis Drug: Albendazole Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : March 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Albendazole

Arm Intervention/treatment
Experimental: 1
Drug: Albendazole
Albendazole 400mg x 3 first dose observed
Other Name: Zentel

Placebo Comparator: 2 Drug: Placebo
Albendazole Placebo 400mg x 3 first dose observed

Primary Outcome Measures :
  1. Change in markers of HIV-1 disease progression [ Time Frame: 12 weeks ]
  2. CD4 count [ Time Frame: 12 weeks ]
  3. HIV-1 RNA level [ Time Frame: 12 weeks ]
  4. Genital HIV-1 RNA levels [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Immune activation markers of global T cell activation [ Time Frame: 12 weeks ]
  2. Numbers of CD4+ and CD8+ T cells expressing Ki67 [ Time Frame: 12 weeks ]
  3. Naïve and memory T cell subsets [ Time Frame: 12 weeks ]
  4. Type and number of helminth co-infections [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00130910

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Kenya Medical Research Institute
Nairobi, Kenya
Sponsors and Collaborators
University of Washington
Kenya Medical Research Institute
University of Nairobi
Kenyatta National Hospital
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Study Director: Judd L Walson, MD, MPH University of Washington
Principal Investigator: Grace C. John-Stewart, MD, PhD, MPH University of Washington
2004 report on the global AIDS epidemic : 4th global report. UNAIDS

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00130910    
Other Study ID Numbers: 06-1127-D03
NIH 5 P30 AI027757-19
UW Royalty Research Fund #3335
First Posted: August 16, 2005    Key Record Dates
Last Update Posted: November 15, 2007
Last Verified: November 2007
Keywords provided by University of Washington:
Intestinal immune activation
Treatment Naive
Additional relevant MeSH terms:
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Virus Diseases
Parasitic Diseases
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents