NCT00507221: THE or PHE

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

Completed NA Last updated 18 November 2014

What this trial tests

NA trial testing Albendazole in HIV Infections in 948 participants. Completed in 1 October 2011.

Timeline

1 February 2008

Primary endpoint
1 July 2011

1 October 2011

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	948
Start date	1 February 2008
Primary completion	1 July 2011
Estimated completion	1 October 2011
Sites	1 location across Kenya

Drugs / interventions tested

• Albendazole (ALBENDAZOLE) — full drug profile →
• Praziquantel — full drug profile →
• Current standard of care in Kenya — full drug profile →

Conditions studied

• HIV Infections — all drugs for HIV Infections →
• Helminthiasis — all drugs for Helminthiasis →

Sponsor

University of Washington

Who can join

18 and older, any sex, with HIV Infections or Helminthiasis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early loss to follow-up of recently diagnosed HIV-infected adults from routine pre-ART care in a rural district hospital in Kenya: a cohort study.
   Hassan AS, Fielding KL, Thuo NM, Nabwera HM, et al · · 2012 · cited 39× · PMID 22943164 · DOI 10.1111/j.1365-3156.2011.02889.x
2. Impact of helminth diagnostic test performance on estimation of risk factors and outcomes in HIV-positive adults.
   Arndt MB, John-Stewart G, Richardson BA, Singa B, et al · · 2013 · cited 23× · PMID 24324729 · DOI 10.1371/journal.pone.0081915
3. Humoral immune responses to Plasmodium falciparum among HIV-1-infected Kenyan adults.
   Nnedu ON, O'Leary MP, Mutua D, Mutai B, et al · · 2011 · cited 21× · PMID 21956928 · DOI 10.1002/prca.201100021
4. Soil transmitted helminth infections are not associated with compromised antibody responses to previously administered measles and tetanus vaccines among HIV-1 infected, ART naïve Kenyan adults.
   Storey HL, Singa B, Naulikha J, Horton H, et al · · 2017 · cited 6× · PMID 28924616 · DOI 10.1016/j.parepi.2016.12.003
5. Combined effectiveness of anthelmintic chemotherapy and WASH among HIV-infected adults.
   Means AR, van Lieshout L, Brienen E, Yuhas K, et al · · 2018 · cited 5× · PMID 29346385 · DOI 10.1371/journal.pntd.0005955
6. Use of principal components analysis and protein microarray to explore the association of HIV-1-specific IgG responses with disease progression.
   Gerns Storey HL, Richardson BA, Singa B, Naulikha J, et al · · 2014 · cited 2× · PMID 24134221 · DOI 10.1089/aid.2013.0088
7. Prevalence and correlates of insecticide-treated bednet use among HIV-1-infected adults in Kenya.
   Nnedu ON, John-Stewart GC, Singa BO, Piper B, et al · · 2012 · cited 2× · PMID 22533793 · DOI 10.1080/09540121.2012.674094