Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression (THE or PHE)
|ClinicalTrials.gov Identifier: NCT00507221|
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : November 20, 2014
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||948 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
Every 3 months for 24 months (enrollment 3, 6, 9, 12, 15, 18, 21, and 24 months):
400mg/day X 3 days
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.
- 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.
- HIV-1 RNA level [ Time Frame: enrollment, 12, and 24 months. ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507221
|Kenya Medical Research Institute|
|Principal Investigator:||Judd L Walson, MD, MPH||University of Washington|