HIV InfectionsPhase 4TIMENCT01014481
Appropriate Timing of HAART in Co-infected HIV/TB Patients
A Phase 4 study testing tenofovir, lamivudine, efavirenz in people with HIV Infections and Tuberculosis, run by Bamrasnaradura Infectious Diseases Institute at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- tenofovir, lamivudine, efavirenz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2009to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health
Nonthaburi, Changwat Nonthaburi, 11000
About this study
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)
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.
Read the 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.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- tenofovir, lamivudine, efavirenz
- Keywords
- HIV, tuberculosis, antiretroviral treatment, timing
- Medical subject headings
- HIV Infections, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenofovir, lamivudine, efavirenzDrug
Also called at 4 weeks versus at 12 weeks after tuberculosis treatment
initiate tenofovir 300 mg/day, lamivudine 300 mg/day, efavirenz 600 mg/day between at 4 weeks and at 12 weeks after tuberculosis treatment
| Study group | Role | What they receive |
|---|---|---|
| start antiretroviral treatment | Experimental | 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 Receives: Drug: tenofovir, lamivudine, efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
death rate
Measured: 48 weeeks
Secondary outcomes (5)
hospitalization
Measured: 48 weeks
adverse events
Measured: 48 weeks
composite endpoint of a. death b. hospitalization and c. adverse event
Measured: 48 weeks
TB IRIS
Measured: 48 weeks
Risk of death
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: this study was ended prematurely by ethical committees with a reason of the final outcome was achieved with no longer recruitment was needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bamrasnaradura Infectious Diseases Institute
- Sponsor type
- Other government
- Collaborators
- Mahidol University, Thai Red Cross AIDS Research Centre
- Investigators
- Weerawat Manosuthi, MD, Principal investigator, Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014481
- Sponsor's protocol ID
- 0435.3/1551
- Acronym
- TIME
- Status last verified
- Nov 2011
- First submitted
- 16 Nov 2009
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22115397
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01014481
- Acronym / sponsor ID
- TIME / 0435.3/1551
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- HIV, tuberculosis, antiretroviral treatment, timing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: this study was ended prematurely by ethical committees with a reason of the final outcome was achieved with no longer recruitment was needed.
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Bamrasnaradura Infectious Diseases InstituteOther government
- Collaborators
- Mahidol University, Thai Red Cross AIDS Research Centre
- Study start
- Oct 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| start antiretroviral treatment | Experimental | Drug: tenofovir, lamivudine, efavirenzthe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tenofovir, lamivudine, efavirenzAlso: at 4 weeks versus at 12 weeks after tuberculosis treatmentinitiate tenofovir 300 mg/day, lamivudine 300 mg/day, efavirenz 600 mg/day between at 4 weeks and at 12 weeks after tuberculosis treatment | Drug | start antiretroviral treatment |
Primary outcome
death rate
Time frame: 48 weeeks
5 secondary outcomes
hospitalization
Time frame: 48 weeks
adverse events
Time frame: 48 weeks
composite endpoint of a. death b. hospitalization and c. adverse event
Time frame: 48 weeks
TB IRIS
Time frame: 48 weeks
Risk of death
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: this study was ended prematurely by ethical committees with a reason of the final outcome was achieved with no longer recruitment was needed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
- Derived from this study: PubMed 22115397Kiertiburanakul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weerawat Manosuthi, MD principal investigator
Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tenofovir, lamivudine, efavirenz in people with HIV Infections and Tuberculosis, run by Bamrasnaradura Infectious Diseases Institute at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: this study was ended prematurely by ethical committees with a reason of the final outcome was achieved with no longer recruitment was needed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death rate (time frame: 48 weeeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01014481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2011.