Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226434
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2005-09-23
Brief Title:
Early vs Late Introduction of Antiretroviral Therapy in HIV-infected Patients With Tuberculosis ANRS 1295 CAMELIA
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Early vs Late Introduction of Antiretroviral Therapy in Naive HIV-infected Patients With Tuberculosis in Cambodia
Status:
COMPLETED
Status Verified Date:
2012-03
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:
In Cambodia the prevalence of both tuberculosis TB and Human Immunodeficiency Virus HIV infection is high Data suggest that aggressive management of HIV infection which includes Anti-Retroviral Therapy HAART during treatment of TB decreases both morbidity and mortality On the other hand the use of HAART for patients with TB may cause severe complications due to drug-drug interactions and occasionally a temporary exacerbation of symptoms These reactions may be particularly severe when HAART is started soon after the start of TB treatment
The proposed study aims to determine the optimal time to initiate HAART in previously untreated HIV-infected adult patients with TB and low CD4 cell counts
The proposed study aims to determine the optimal time to initiate HAART in previously untreated HIV-infected adult patients with TB and low CD4 cell counts
Detailed Description:
In Cambodia the prevalence of both tuberculosis TB and Human Immunodeficiency Virus HIV infection is high In 2000 there were approximately 75000 newly diagnosed TB cases In 2003 19 of the population was infected with HIV TB rates in Cambodia are more than double those observed in other developing countries and up to 30 times higher than those currently seen in the USA or Western Europe It is estimated that over 8 of the newly diagnosed TB cases are co-infected with HIV of which approximately 85 are severely immunosuppressed CD4 cell count 200 x 106 cellsl
Mortality rates were found to be 2-4 folds higher in HIVTB co-infected patients than in TB alone Data suggest that aggressive management of HIV infection which includes Highly Active Anti-Retroviral Therapy HAART during treatment of TB decreases both morbidity and mortality by suppressing viral replication and improving immune function
On the other hand the use of HAART for patients with TB may cause severe complications due to drug-drug interactions and occasionally a temporary exacerbation of symptoms signs or radiographic manifestations of TB Such events or paradoxical reactions that occur among 7 - 36 of HIVTB co-infected patients treated with HAART may be secondary to immune restitution These reactions may be particularly severe when HAART is started soon after the start of TB treatment
Most clinical teams recommend delaying the initiation of HAART to avoid the early side effects of TB treatment and simplify clinical management of the co-infected patient However others argue that early initiation of HAART in TB patients with CD4 cell counts 100 x 106 cellsl leads to a marked reduction of viral load despite frequent adverse events
The proposed study aims to determine the optimal time to initiate HAART defined as d4T 3TC efavirenz in previously untreated HIV-infected adult patients with TB and low CD4 cell counts The study is a multicentre prospective randomized open-label two-armed trial with no placebo It is designed as a superiority trial to compare the early arm HAART initiated 2 weeks after TB treatment onset with the late arm HAART initiated 2 months after TB treatment onset Efficacy will be assessed by the survival rate in the two arms Secondary objectives will include evaluation of 1 the safety of an early initiation of HAART in terms of drug interactions or paradoxical reactions 2 the occurrence of opportunistic infections diagnosed during the follow-up period 3 patients adherence to TB treatment and HAART 4 the rate of hospitalization for any cause during the trial the measure of 5 the effectiveness of the TB treatment and HAART and 6 the predictive factors for the survival the response to anti-TB therapy and HAART and the paradoxical reactions
The total study duration is expected to be 4 years 3 years for enrolment and at least one year of follow-up in five study sites 1 Khmero-Soviet Friendship Hospital Phnom Penh 2 Calmette Hospital Phnom Penh 3 Provincial hospital Svay Rieng province and 4 Provincial hospital Takeo province 5 Provincial Hospital Siem Reap
The study will be carried out in compliance with the protocol and in accordance with the Declaration of Helsinki approved by the World Health Association and with the recommendations of the Good Clinical Practice
Mortality rates were found to be 2-4 folds higher in HIVTB co-infected patients than in TB alone Data suggest that aggressive management of HIV infection which includes Highly Active Anti-Retroviral Therapy HAART during treatment of TB decreases both morbidity and mortality by suppressing viral replication and improving immune function
On the other hand the use of HAART for patients with TB may cause severe complications due to drug-drug interactions and occasionally a temporary exacerbation of symptoms signs or radiographic manifestations of TB Such events or paradoxical reactions that occur among 7 - 36 of HIVTB co-infected patients treated with HAART may be secondary to immune restitution These reactions may be particularly severe when HAART is started soon after the start of TB treatment
Most clinical teams recommend delaying the initiation of HAART to avoid the early side effects of TB treatment and simplify clinical management of the co-infected patient However others argue that early initiation of HAART in TB patients with CD4 cell counts 100 x 106 cellsl leads to a marked reduction of viral load despite frequent adverse events
The proposed study aims to determine the optimal time to initiate HAART defined as d4T 3TC efavirenz in previously untreated HIV-infected adult patients with TB and low CD4 cell counts The study is a multicentre prospective randomized open-label two-armed trial with no placebo It is designed as a superiority trial to compare the early arm HAART initiated 2 weeks after TB treatment onset with the late arm HAART initiated 2 months after TB treatment onset Efficacy will be assessed by the survival rate in the two arms Secondary objectives will include evaluation of 1 the safety of an early initiation of HAART in terms of drug interactions or paradoxical reactions 2 the occurrence of opportunistic infections diagnosed during the follow-up period 3 patients adherence to TB treatment and HAART 4 the rate of hospitalization for any cause during the trial the measure of 5 the effectiveness of the TB treatment and HAART and 6 the predictive factors for the survival the response to anti-TB therapy and HAART and the paradoxical reactions
The total study duration is expected to be 4 years 3 years for enrolment and at least one year of follow-up in five study sites 1 Khmero-Soviet Friendship Hospital Phnom Penh 2 Calmette Hospital Phnom Penh 3 Provincial hospital Svay Rieng province and 4 Provincial hospital Takeo province 5 Provincial Hospital Siem Reap
The study will be carried out in compliance with the protocol and in accordance with the Declaration of Helsinki approved by the World Health Association and with the recommendations of the Good Clinical Practice
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 |
|---|---|---|---|
| CIPRA KH 001 | None | None | None |