Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078247
Status:
COMPLETED
Last Update Posted:
2010-08-12
First Post:
2004-02-20
Brief Title:
Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Delaying HIV Disease Progression With Punctuated Antiretroviral Therapy in HIV-Associated Tuberculosis
Status:
COMPLETED
Status Verified Date:
2010-08
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 is designed to determine whether 6 months of anti-HIV drugs given along with tuberculosis treatment will delay the onset of AIDS in HIV infected African patients
Detailed Description:
Tuberculosis TB is a common and serious complication of HIV infection in the developing world especially in sub-Saharan Africa Since the emergence of the HIV epidemic in Africa the incidence rates of TB have risen dramatically overwhelming national TB control programs across the continent Over 50 of TB patients presenting to TB clinics in Africa are HIV infected These patients often present in the early stages of HIV infection
Recent World Health Organization guidelines on the management of HIV-associated pulmonary TB recommend antiretroviral ARV therapy in patients with CD4 cells less than 200 cellsmm3 but not for HIV infected TB patients who present with a high CD4 count In Uganda over half of HIV infected patients with active TB present to TB clinics with CD4 counts above 200 cellsmm3 and there is evidence that coinfected patients with a high CD4 count should be treated with ARV therapy First mortality in HIV-associated TB is high even when patients respond to effective anti-tuberculosis therapy Second excess mortality associated with TB is most evident when CD4 counts are above 200 cellmm3 Third in coinfected patients TB results in prolonged immune activation which may enhance viral replication and accelerate the decline of CD4 cells
This study will evaluate whether short-term ARV therapy of abacavir sulfate lamivudine and zidovudine given during treatment of active TB will slow progression of HIV disease in TB patients with CD4 counts of at least 350 cellsmm3 The study will also assess the possible risks eg drug toxicities and resistance and benefits eg more rapid clearance of mycobacterium tuberculosis and reduced TB relapse of punctuated ARV therapy
Participants in this study will be HIV infected TB patients with CD4 counts of at least 350 cellsmm3 All participants will receive treatment for TB Participants will be randomly assigned to receive 6 months of ARV therapy or to delay ARV therapy until CD4 counts drop below 250 cellsmm3 The participants will be followed for 2 years CD4 counts will be compared between groups
This study will also follow a group of HIV infected patients without active TB to quantify the extent to which CD4 cell decline is accelerated with active TB and to determine the extent to which a decline is neutralized in patients who receive punctuated ARV therapy
Recent World Health Organization guidelines on the management of HIV-associated pulmonary TB recommend antiretroviral ARV therapy in patients with CD4 cells less than 200 cellsmm3 but not for HIV infected TB patients who present with a high CD4 count In Uganda over half of HIV infected patients with active TB present to TB clinics with CD4 counts above 200 cellsmm3 and there is evidence that coinfected patients with a high CD4 count should be treated with ARV therapy First mortality in HIV-associated TB is high even when patients respond to effective anti-tuberculosis therapy Second excess mortality associated with TB is most evident when CD4 counts are above 200 cellmm3 Third in coinfected patients TB results in prolonged immune activation which may enhance viral replication and accelerate the decline of CD4 cells
This study will evaluate whether short-term ARV therapy of abacavir sulfate lamivudine and zidovudine given during treatment of active TB will slow progression of HIV disease in TB patients with CD4 counts of at least 350 cellsmm3 The study will also assess the possible risks eg drug toxicities and resistance and benefits eg more rapid clearance of mycobacterium tuberculosis and reduced TB relapse of punctuated ARV therapy
Participants in this study will be HIV infected TB patients with CD4 counts of at least 350 cellsmm3 All participants will receive treatment for TB Participants will be randomly assigned to receive 6 months of ARV therapy or to delay ARV therapy until CD4 counts drop below 250 cellsmm3 The participants will be followed for 2 years CD4 counts will be compared between groups
This study will also follow a group of HIV infected patients without active TB to quantify the extent to which CD4 cell decline is accelerated with active TB and to determine the extent to which a decline is neutralized in patients who receive punctuated ARV therapy
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 |
|---|---|---|---|
| 1R01AI051219-01A2 | NIH | None | httpsreporternihgovquickSearch1R01AI051219-01A2 |