- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00344279
Changes in HIV Viral Load in Patients Undergoing Treatment for Filariasis
Changes in HIV Viral Load in Patients Undergoing Treatment for Filarial Infection
This study, sponsored by the National Institutes of Health and the Tuberculosis Research Centre and YRG-Care in Chennai, India, will examine how treatment of lymphatic filariasis in HIV-infected patients influences the amount of HIV virus in the blood and the progression of HIV infection to AIDS. Filarial infections are common in Chennai, and it is important to understand whether treatment of filariasis affects the course of HIV disease. The information gained from this study could be used to modify treatments for people both with HIV and filarial infections.
Patients 18 years of age and older who are receiving treatment for HIV infection at the Government Hospital HIV clinic or YRG-Care may be eligible for this study. Two groups of patients will be recruited - patients with both HIV and filarial infections, and patients who have HIV infection alone, without filariasis. Candidates are screened with a medical history and review of medical records, physical examination, and blood and stool tests. Women have a urine pregnancy test.
Within one month of screening, all participants receive a single dose of diethylcarbamazine and albendazole, a drug regimen commonly used to treat filarial infection. Patients are followed closely for the first 2 weeks after treatment to check for side effects. They are then seen at 1, 3, 6 and 12 months after the treatment dose for a physical examination and blood test.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Chennai, India
- Government General Hospital
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Chennai, India
- Tuberculosis Research Centre
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Chennai, India
- YRG Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
Greater than 18 years of age.
Ability to give informed consent
HIV positive
If on antiretrovirals or treatment for opportunistic infections, have it be a stable maintenance period of at least 2 months
Male or female, providing women are neither pregnant nor breast-feeding
Willingness to adhere to the testing schedule of the protocol and to provide small amounts of blood (5 ml) on multiple occasions
Willingness to be treated with DEC/albendazole
Willingness, if female, to be tested for pregnancy and to be informed of the test result
Willingness to have samples stored for future research
EXCLUSION CRITERIA:
Acutely ill at the time of enrollment into the study i.e. newly diagnosed with an opportunistic infection and not yet stabilized on a treatment regime.
Hemoglobin less than 9 g/l for women and less than 10 g/l for men
AST, ALT greater than 5 times normal
Evidence of acute HIV infection (acute antiretroviral syndrome)
Active tuberculosis or known tuberculosis
A true allergy to DEC or albendazole
At the discretion of the investigator if it is felt that someone is not appropriate for the study (i.e. known active drug use, patient with history of chronic noncompliance in clinic visits)
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Bloland PB, Wirima JJ, Steketee RW, Chilima B, Hightower A, Breman JG. Maternal HIV infection and infant mortality in Malawi: evidence for increased mortality due to placental malaria infection. AIDS. 1995 Jul;9(7):721-6. doi: 10.1097/00002030-199507000-00009.
- Brown M, Kizza M, Watera C, Quigley MA, Rowland S, Hughes P, Whitworth JA, Elliott AM. Helminth infection is not associated with faster progression of HIV disease in coinfected adults in Uganda. J Infect Dis. 2004 Nov 15;190(10):1869-79. doi: 10.1086/425042. Epub 2004 Oct 20.
- Bush CE, Donovan RM, Markowitz NP, Kvale P, Saravolatz LD. A study of HIV RNA viral load in AIDS patients with bacterial pneumonia. J Acquir Immune Defic Syndr Hum Retrovirol. 1996 Sep;13(1):23-6. doi: 10.1097/00042560-199609000-00004.
- Talaat KR, Babu S, Menon P, Kumarasamy N, Sharma J, Arumugam J, Dhakshinamurthy K, Srinivasan R, Poongulali S, Gu W, Fay MP, Swaminathan S, Nutman TB. Treatment of W. bancrofti (Wb) in HIV/Wb coinfections in South India. PLoS Negl Trop Dis. 2015 Mar 20;9(3):e0003622. doi: 10.1371/journal.pntd.0003622. eCollection 2015 Mar.
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999905220
- 05-I-N220
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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