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Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression (THE or PHE)
This study is enrolling participants by invitation only.
First Received: July 24, 2007   Last Updated: December 2, 2009   History of Changes
Sponsor: University of Washington
Collaborators: Centers for Disease Control and Prevention
Kenya Medical Research Institute
Information provided by: University of Washington
ClinicalTrials.gov Identifier: NCT00507221
  Purpose

Abstract:

Over 25 million HIV-1 infected individuals are currently living in Africa and as many as 50-90% may be co-infected with soil transmitted helminths such as roundworms, hookworms or whipworms. Helminth infection in HIV-1-infected individuals may increase HIV-1 RNA levels and increase the rate of progression of HIV-1 to AIDS. Studies have also shown that successful treatment of helminth co-infection (as documented by clearance of helminth eggs in stool) led to a significant decrease in HIV-1 plasma viral load (-0.36 log10). This change in viral load was significantly greater than that seen in those individuals without documented clearance of their helminth co-infection (+0.67 log10) (p=0.04). Studies conducted in Africa have shown an estimated 2.5-fold increased risk for sexual transmission of the HIV-1 for each log increase in plasma HIV-1 viral load. In addition to direct effects on plasma viral load, the rate of CD4 cell decline in helminth infected individuals may be directly impacted by the significant immune activation seen with such co-infection.

The investigators propose a randomized controlled trial examining the potential benefits of routine empiric helminth eradication in HIV-1 infected adults who do not yet qualify for antiretroviral (ARV) therapy in Kenya. The current standard of care of symptomatic diagnosis and treatment will be compared to a systematic empiric scheduled de-worming program for HIV infected adults. The investigators will compare markers of disease progression including rate of CD4 decline and changes in HIV-1 RNA levels between the two treatment arms.


Condition Intervention
HIV Infections
Helminthiasis
Drug: Albendazole
Drug: Praziquantel
Drug: Current standard of care in Kenya

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • CD4 count [ Time Frame: every 6 months for 24 months (enrollment and months 6, 12, 18, and 24 ) ] [ Designated as safety issue: Yes ]
  • HIV-1 RNA level [ Time Frame: enrollment, 12, and 24 months. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Markers of clinical disease progression as measured by WHO staging criteria [ Time Frame: Every 3 months for 24 months (enrollment, months 3, 6, 9, 12, 15, 18, 21, and 24) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1050
Study Start Date: February 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Arm 1 will receive an intensive regimen of anti-helminthic therapy consisting of albendazole every three months for two years and praziquantel at enrollment and at one year of follow up.
Drug: Albendazole

Every 3 months for 24 months (enrollment 3, 6, 9, 12, 15, 18, 21, and 24 months):

400mg/day X 3 days

Drug: Praziquantel
At enrollment and 12 months: 25mg/kg X 1
2: Active Comparator
Arm 2 will receive symptomatic diagnosis and treatment of helminth infection as is current standard of care in Kenya.
Drug: Current standard of care in Kenya
Current standard of care for HIV patients in Kenya based on WHO guidelines.

  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 CD4 count > 350 cells/mm3 in order to be enrolled in the randomized controlled trial.
  • 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.

Exclusion Criteria:

• Participants must not be pregnant at the time of enrollment (by urine HCG testing).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507221

Locations
Kenya
Kenya Medical Research Institute
Nairobi, Kenya
Sponsors and Collaborators
University of Washington
Kenya Medical Research Institute
Investigators
Principal Investigator: Judd L Walson, MD, MPH University of Washington
  More Information

Publications:
Responsible Party: University of Washington ( Judd L Walson, MD, MPH )
Study ID Numbers: 32274-B, KEMRI SSC #1251; 07-6824-B 01
Study First Received: July 24, 2007
Last Updated: December 2, 2009
ClinicalTrials.gov Identifier: NCT00507221     History of Changes
Health Authority: United States: Institutional Review Board;   Kenya: Ministry of Health

Keywords provided by University of Washington:
HIV
Helminthiasis
Co-infection
Treatment Naive

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
Antiprotozoal Agents
Sexually Transmitted Diseases, Viral
Disease Attributes
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Disease Progression
Infection
Albendazole
Antiparasitic Agents
Pathologic Processes
Therapeutic Uses
Parasitic Diseases
Praziquantel
Retroviridae Infections
Helminthiasis
RNA Virus Infections
Immune System Diseases
Antiplatyhelmintic Agents
Mitosis Modulators
Acquired Immunodeficiency Syndrome
Anthelmintics
Antimitotic Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Anticestodal Agents
Virus Diseases
HIV Infections

ClinicalTrials.gov processed this record on February 08, 2010