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Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression (THE or PHE)

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: NCT00507221
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : November 20, 2014
Centers for Disease Control and Prevention
Kenya Medical Research Institute
Information provided by (Responsible Party):
Judd Walson, University of Washington

Brief Summary:


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 or disease Intervention/treatment Phase
HIV Infections Helminthiasis Drug: Albendazole Drug: Praziquantel Drug: Current standard of care in Kenya Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 948 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression
Study Start Date : February 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: 1
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

Active Comparator: 2
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.

Primary Outcome Measures :
  1. CD4 count [ Time Frame: every 6 months for 24 months (enrollment and months 6, 12, 18, and 24 ) ]
    The primary measure of efficacy for the randomized clinical trial is the time to ART eligibility and the time to CD4 counts of less than 200 and 350 cells/mm3.

  2. HIV-1 RNA level [ Time Frame: enrollment, 12, and 24 months. ]

Secondary Outcome Measures :
  1. 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) ]
    Secondary measures of efficacy will include changes in WHO Clinical Staging, development of IRIS, time to hospitalization, time to death, time to initiation of ARVs and CD4 response to ARVs as well as the development of IRIS among those who initiate ARVs.

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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 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).

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): NCT00507221

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Kenya Medical Research Institute
Nairobi, Kenya
Sponsors and Collaborators
University of Washington
Centers for Disease Control and Prevention
Kenya Medical Research Institute
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Principal Investigator: Judd L Walson, MD, MPH University of Washington
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Judd Walson, Principal Investigator, University of Washington Identifier: NCT00507221    
Other Study ID Numbers: 32274-B
KEMRI SSC #1251; 07-6824-B 01
First Posted: July 26, 2007    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014
Keywords provided by Judd Walson, University of Washington:
Treatment Naive
Additional relevant MeSH terms:
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Communicable Diseases
Disease Progression
Virus Diseases
Disease Attributes
Pathologic Processes
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