Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004736
Status:
COMPLETED
Last Update Posted:
2008-09-11
First Post:
2000-02-25
Brief Title:
Effectiveness of Anti-HIV Therapy HAART in HIV-Infected Patients With Tuberculosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Viral and Immune Dynamics in HIV-Infected Patients With Tuberculosis
Status:
COMPLETED
Status Verified Date:
2003-06
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:
The purpose of this study is to see if a type of anti-HIV therapy called HAART is effective in lowering levels of HIV and boosting the immune system in HIV-infected patients with tuberculosis TB
HIV-infected patients with TB have higher levels of HIV and lower CD4 cell counts cells in the body that fight infection than HIV-infected patients without TB HAART has been effective in reducing HIV levels and increasing CD4 cells in patients without TB However its effects in HIV-infected patients with TB are unknown
HIV-infected patients with TB have higher levels of HIV and lower CD4 cell counts cells in the body that fight infection than HIV-infected patients without TB HAART has been effective in reducing HIV levels and increasing CD4 cells in patients without TB However its effects in HIV-infected patients with TB are unknown
Detailed Description:
Previous studies have focused on characterizing viral and immune dynamics after initiation of HAART in patients without opportunistic infection The development of TB in HIV-infected individuals is associated with an elevation in HIV RNA levels a decrease in CD4 cell counts and an increase in activated CD38 lymphocytes and proinflammatory cytokines IL-1 TNF-alpha and IL-6 Response to HAART may differ in individuals with an active opportunistic infection such as TB
HIV-infected patients with active TB follow an anti-TB regimen including rifabutin and are observed for a maximum of 24 weeks before they initiate HAART Plasma samples for 24-hour post-rifabutin dosing are collected at entry and at Weeks 4 8 and 12 then again at Weeks 2 3 4 12 and 24 after HAART initiation Analyses of these samples are used to explore the relationship between cytokines and rifabutin metabolism and the effect of nelfinavir on rifabutin pharmacokinetics The HAART regimen is nelfinavir plus lamivudine 3TC plus either zidovudine ZDV or stavudine d4T After initiation of HAART all patients undergo intensive monitoring of viral and immune dynamics for 2 months The patients continue to be followed for 1 year from the time of starting HAART Neither the HAART drug regimen nor anti-TB medications will be provided by the study and must be obtained by prescription If patients are intolerant of the HAART regimen or exhibit virologic rebound primary providers can alter or modify this regimen As part of substudy A5065s patients who experience signs or symptoms of paradoxical reactions ie new persistent fevers that develop after initiating HAART and which last for more than 1 week without an identifiable source marked worsening or emergence of intrathoracic lymphadenopathy pulmonary infiltrates worsening or emergence of cervical adenopathy on serial physical examinations or worsening of other tuberculous lesions have additional clinical evaluations including a chest x-ray a target clinical assessment concomitant medications and signs and symptoms weekly for 4 weeks then every month thereafter until the symptoms resolve
HIV-infected patients with active TB follow an anti-TB regimen including rifabutin and are observed for a maximum of 24 weeks before they initiate HAART Plasma samples for 24-hour post-rifabutin dosing are collected at entry and at Weeks 4 8 and 12 then again at Weeks 2 3 4 12 and 24 after HAART initiation Analyses of these samples are used to explore the relationship between cytokines and rifabutin metabolism and the effect of nelfinavir on rifabutin pharmacokinetics The HAART regimen is nelfinavir plus lamivudine 3TC plus either zidovudine ZDV or stavudine d4T After initiation of HAART all patients undergo intensive monitoring of viral and immune dynamics for 2 months The patients continue to be followed for 1 year from the time of starting HAART Neither the HAART drug regimen nor anti-TB medications will be provided by the study and must be obtained by prescription If patients are intolerant of the HAART regimen or exhibit virologic rebound primary providers can alter or modify this regimen As part of substudy A5065s patients who experience signs or symptoms of paradoxical reactions ie new persistent fevers that develop after initiating HAART and which last for more than 1 week without an identifiable source marked worsening or emergence of intrathoracic lymphadenopathy pulmonary infiltrates worsening or emergence of cervical adenopathy on serial physical examinations or worsening of other tuberculous lesions have additional clinical evaluations including a chest x-ray a target clinical assessment concomitant medications and signs and symptoms weekly for 4 weeks then every month thereafter until the symptoms resolve
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 |
|---|---|---|---|
| AACTG A5062 | None | None | None |