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Sponsors and Collaborators: |
University of Washington Kenya Medical Research Institute University of Nairobi Kenyatta Hospital |
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Information provided by: | University of Washington |
ClinicalTrials.gov Identifier: | NCT00130910 |
Identifying methods to slow disease progression in patients with HIV-1 infection remains a top priority in many regions of the world. In many countries, medications known to slow progression are not readily affordable or available. Many of the individuals living in these countries are also co-infected with a variety of other diseases such as tuberculosis, malaria and soil-transmitted helminths. There are data to suggest that infection with these agents may activate the immune system in HIV-1 co-infected individuals and may lead to more rapid HIV disease progression. This study will evaluate the potential impact of treating helminths in HIV-1 seropositive individuals. Markers of disease progression and immune activation will be assessed. We will also measure the amount of virus in genital secretions to determine if treatment of co-infection can reduce the infectiousness of HIV in these individuals.
Condition | Intervention |
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HIV Infections Helminthiasis |
Drug: Albendazole Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double Blind, Placebo Controlled Trial of Albendazole in Soil-Transmitted Helminth and HIV-1 co-Infected Kenyan Individuals to Determine the Effect of Such Treatment on HIV-1 Disease Progression and Genital Shedding. |
Enrollment: | 234 |
Study Start Date: | March 2006 |
Study Completion Date: | June 2007 |
Arms | Assigned Interventions |
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1: Experimental
Albendazole
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Drug: Albendazole
Albendazole 400mg x 3 first dose observed
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2: Placebo Comparator |
Drug: Placebo
Albendazole Placebo 400mg x 3 first dose observed
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Kenya | |
Kenya Medical Research Institute | |
Nairobi, Kenya |
Study Director: | Judd L Walson, MD, MPH | University of Washington |
Principal Investigator: | Grace C. John-Stewart, MD, PhD, MPH | University of Washington |
Study ID Numbers: | 06-1127-D03, NIH 5 P30 AI027757-19, UW Royalty Research Fund #3335 |
Study First Received: | August 12, 2005 |
Last Updated: | November 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00130910 |
Health Authority: | United States: Institutional Review Board; Kenya: Ministry of Health |
HIV Helminthiasis Co-infection Intestinal immune activation Treatment Naive |
Albendazole Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Disease Progression Parasitic Diseases Retroviridae Infections Helminthiasis Immunologic Deficiency Syndromes |
Communicable Diseases Anti-Infective Agents Antiprotozoal Agents RNA Virus Infections Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Antiplatyhelmintic Agents Mitosis Modulators |
Anthelmintics Antimitotic Agents Infection Pharmacologic Actions Anticestodal Agents Antiparasitic Agents Therapeutic Uses Tubulin Modulators Lentivirus Infections |