Clinical trial NCT01014481: Appropriate Timing of HAART in Co-infected HIV/TB Patients
Official title: Initiation of a Once Daily Regimen of Tenofovir, Lamivudine and Efavirenz After 4 Weeks Versus 12 Weeks of Tuberculosis Treatment in HIV-1 Infected Patients (Time Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV Infections
Tuberculosis
Keywords: HIV
tuberculosis
antiretroviral treatment
timing
Lead sponsor: Bamrasnaradura Infectious Diseases Institute
Sponsor class: OTHER_GOV
Collaborators: name: Mahidol University
name: Thai Red Cross AIDS Research Centre
First posted: 2009-11-17
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144.

Detailed description: The growing epidemic of HIV poses a serious public health threat in many countries, including Thailand. Mortality is clearly reduced in HIV and tuberculosis (TB) co-infected patients who initiate antiretroviral therapy (ART) after the treatment of TB, but the optimal timing to initiate ART is one of the major concern for patients concurrently receiving both therapies. To date, the prospective, randomized, control trial to study the optimal timing to initiate ART in the patients is still limited. In addition, the current recommendation to start ART in patients co-infected with HIV and TB is still based on expert opinions. Here, the investigators plan to investigate the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144 at Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand.

Eligibility criteria: Inclusion Criteria:

1. 18-65 years of age
2. HIV-1 infected patients
3. Naïve to antiretroviral treatment
4. Baseline CD4 cell count \<350 cells/mm3 at enrolment
5. Diagnosed as having active tuberculosis by clinical features or positive acid fast stain or positive TB culture; and receiving rifampicin containing antituberculous regimen
6. Signed inform consent

Exclusion Criteria:

1. Serum transaminase enzymes ≥ 5 times of upper normal limit or total bilirubin ≥ 3 times of upper normal limit
2. Serum creatinine ≥ 2 times of upper normal limit
3. Lactation or pregnancy
4. Receiving any immunosuppressive agents

Primary outcomes:
measure: death rate
timeFrame: 48 weeeks
Secondary outcomes:
measure: hospitalization
timeFrame: 48 weeks
measure: adverse events
timeFrame: 48 weeks
measure: composite endpoint of a. death b. hospitalization and c. adverse event
timeFrame: 48 weeks
measure: TB IRIS
timeFrame: 48 weeks
measure: Risk of death
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Nonthaburi
country: Thailand
facility: Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health
Study officials:
affiliation: Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand
name: Weerawat Manosuthi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiertiburanakul S, Manosuthi W, Sungkanuparph S. Optimal timing of antiretroviral therapy initiation in patients coinfected with HIV and tuberculosis. Expert Rev Clin Pharmacol. 2011 Mar;4(2):143-6. doi: 10.1586/ecp.11.2. No abstract available.