Changes in HIV Viral Load in Patients Undergoing Treatment for Filariasis

NCT00344279 | Completed

• 2 other identifiers: 99990522005-I-N220
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Filarial Infection; HIV Infections

Keywords

Coinfection; AIDS; Lymphatic Filariasis; Diethylcarbamazine (DEC); Albendazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

Government General Hospital

Chennai, India

Location

Tuberculosis Research Centre

Chennai, India

Location

YRG Care

Chennai, India

Location

Related Publications (4)

• 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.

  PMID: 7546417 BACKGROUND

• 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.

  PMID: 15499545 BACKGROUND

• 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.

  PMID: 8797682 BACKGROUND

• 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.

  PMID: 25793933 DERIVED

MeSH Terms

Conditions

HIV Infections; Coinfection; Acquired Immunodeficiency Syndrome; Elephantiasis, Filarial

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Filariasis; Spirurida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 26, 2006
• Study Start: August 8, 2005
• Study Completion: January 31, 2012
• Last Updated: July 2, 2017

Record last verified: 2012-01-31

Locations

IN (3)