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

This study has been completed.
Sponsor:
Collaborators:
Kenya Medical Research Institute
University of Nairobi
Kenyatta National Hospital
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00130910
First received: August 12, 2005
Last updated: November 13, 2007
Last verified: November 2007
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


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
Experimental: 1
Albendazole
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

  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
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: NCT00130910

Locations
Kenya
Kenya Medical Research Institute
Nairobi, Kenya
Sponsors and Collaborators
University of Washington
Kenya Medical Research Institute
University of Nairobi
Kenyatta National 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

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

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00130910     History of Changes
Other 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
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Helminthiasis
Coinfection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Parasitic Diseases
Infection
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 18, 2014