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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Washington.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Kenya Medical Research Institute
Information provided by (Responsible Party):
Judd Walson, University of Washington
ClinicalTrials.gov Identifier:
NCT00507221
First received: July 24, 2007
Last updated: September 27, 2011
Last verified: September 2011
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]
    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.

  • 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 ]
    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.


Enrollment: 948
Study Start Date: February 2008
Estimated Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
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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: Judd Walson, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00507221     History of Changes
Other Study ID Numbers: 32274-B, KEMRI SSC #1251; 07-6824-B 01
Study First Received: July 24, 2007
Last Updated: September 27, 2011
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Helminthiasis
Disease Progression
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
Disease Attributes
Pathologic Processes
Infection
Albendazole
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on August 28, 2014