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| Sponsors and Collaborators: |
University of Washington 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.
We 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 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. We 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 |
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HIV Infections Helminthiasis |
Drug: Albendazole Drug: Praziquantel Drug: Current standard of care in Kenya |
| MedlinePlus related topics: | AIDS |
| ChemIDplus related topics: | Albendazole Praziquantel |
| 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 |
| Estimated Enrollment: | 850 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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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.
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Drug: Albendazole
Every 3 months for 24 months (enrolment 3, 6, 9, 12, 15, 18, 21 and 24 months): 400mg/day X 3 days
At enrolment and 12 months: 25mg/kg X 1
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2: Active Comparator
Arm 2 will receive symptomatic diagnosis and treatment of helminth infection as is current standard of care in Kenya.
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Drug: Current standard of care in Kenya
Current standard of care for HIV patients in Kenya based on WHO guidelines.
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
• Participants must not be pregnant at the time of enrollment (by urine HCG testing).
Contacts and Locations| Contact: Judd L Walson, MD, MPH | +254 72 1165696 | walson@u.washington.edu |
| Kenya | |||||
| Kenya Medical Research Institute | Recruiting | ||||
| Nairobi, Kenya | |||||
| Contact: Ben Piper, MPH, MEM +254 72 9048847 benpiper@washington.edu | |||||
| Sub-Investigator: Phelgona Otieno, MBChB, MMed | |||||
| University of Washington |
| Centers for Disease Control and Prevention |
| Kenya Medical Research Institute |
| Principal Investigator: | Judd L Walson, MD, MPH | University of Washington |
More Information
| Responsible Party: | University of Washington ( Judd L Walson, MD, MPH ) |
| Study ID Numbers: | 07-6824-B 01, KEMRI SSC #1251 |
| First Received: | July 24, 2007 |
| Last Updated: | February 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00507221 |
| Health Authority: | United States: Institutional Review Board; Kenya: Ministry of Health |
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