Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
University of Washington
Collaborators:
Centers for Disease Control and Prevention Kenya Medical Research Institute