Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00344279
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-23
Brief Title:
Changes in HIV Viral Load in Patients Undergoing Treatment for Filariasis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Changes in HIV Viral Load in Patients Undergoing Treatment for Filarial Infection
Status:
COMPLETED
Status Verified Date:
2012-01-31
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
To determine the effect of pre-existing filarial infection and its treatment on viral burden and clinical parameters in patients infected with HIV this study aims to follow plasma HIV loads CD4 counts and clinical parameters in a population of HIV-infected individuals co-infected with Wuchereria bancrofti prior to and after treatment of filarial infection The study individuals will be drawn from the patient cohort followed by the HIV Clinic at the Government General Hospital and the Tuberculosis Research Centre Chennai India or those from YRG-Care Chennai India an area endemic for lymphatic filariasis LF and where the prevalence of HIV infection in the general population is about 7 These patients are adults of all ages both males and females come from the states of Tamil Nadu and Andhra Pradhesh Having established as part of a previous protocol 01-I-N022 an HIVfilarial coprevalence of 6-10 based on W bancrofti circulating antigen detection in HIV-positive and -negative individuals patients in whom co-infection with HIV and LF has been diagnosed will be paired with two HIV-positive but filarial antigen negative clinic controls matched for age gender viral load antiretroviral therapy and CD4 count All efforts will be made to connect study participants with programs for antiretroviral distribution Within a month of a baseline clinical evaluation patients and controls will receive a single dose of the combination of diethylcarbamazinealbendazole the drug combination given as part of national campaigns to eliminate LF and will then be followed with viral loads CD4 counts and clinical examinations at one week as well as 1 3 6 and 12 months after the administration By assessing these changes the influence of a co-existing filarial infection on plasma HIV viral load CD4 count and clinical course can be determined At the end of the study period all participants will be re-assessed for filarial antibody and antigen to ensure absence of the parasite Any patient who has evidence of ongoing filarial infection with W bancrofti will be re-treated with DECalbendazole
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-I-N220 | None | None | None |