Appropriate Timing of HAART in Co-infected HIV/TB Patients (TIME)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Tuberculosis |
Drug: tenofovir, lamivudine, efavirenz |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
- death rate [ Time Frame: 48 weeeks ] [ Designated as safety issue: Yes ]
- hospitalization [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- composite endpoint of a. death b. hospitalization and c. adverse event [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- TB IRIS [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Risk of death [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 156 |
| Study Start Date: | October 2009 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: start antiretroviral treatment
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
|
Drug: tenofovir, lamivudine, efavirenz
initiate tenofovir 300 mg/day, lamivudine 300 mg/day, efavirenz 600 mg/day between at 4 weeks and at 12 weeks after tuberculosis treatment
Other Name: at 4 weeks versus at 12 weeks after tuberculosis treatment
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18-65 years of age
- HIV-1 infected patients
- Naïve to antiretroviral treatment
- Baseline CD4 cell count <350 cells/mm3 at enrolment
- Diagnosed as having active tuberculosis by clinical features or positive acid fast stain or positive TB culture; and receiving rifampicin containing antituberculous regimen
- Signed inform consent
Exclusion Criteria:
- Serum transaminase enzymes ≥ 5 times of upper normal limit or total bilirubin ≥ 3 times of upper normal limit
- Serum creatinine ≥ 2 times of upper normal limit
- Lactation or pregnancy
- Receiving any immunosuppressive agents
Contacts and Locations| Thailand | |
| Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health | |
| Nonthaburi, Thailand, 11000 | |
| Principal Investigator: | Weerawat Manosuthi, MD | Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand |
More Information
No publications provided by Bamrasnaradura Infectious Diseases Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Weerawat Manosuthi, Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health |
| ClinicalTrials.gov Identifier: | NCT01014481 History of Changes |
| Other Study ID Numbers: | 0435.3/1551 |
| Study First Received: | November 16, 2009 |
| Last Updated: | November 16, 2011 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Bamrasnaradura Infectious Diseases Institute:
|
HIV tuberculosis antiretroviral treatment timing |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Lamivudine Tenofovir Tenofovir disoproxil Efavirenz Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 16, 2013