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Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression

NCT00507221 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 948

Last updated 2014-11-20

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Helminthiasis

Interventions

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

DRUG

Current standard of care in Kenya

Current standard of care for HIV patients in Kenya based on WHO guidelines.

Sponsors & Collaborators

Principal Investigators

  • Judd L Walson, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-07-31
Completion
2011-10-31

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00507221 on ClinicalTrials.gov