HIV InfectionsPhase 3TEMPRANONCT00495651
Early Antiretroviral Treatment and/or Early Isoniazid Prophylaxis Against Tuberculosis in HIV-infected Adults (ANRS 12136 TEMPRANO)
A Phase 3 study testing Antiretroviral medications and Antiretroviral medications+Isoniazid prophylaxis in people with HIV Infections and Tuberculosis, run by French National Agency for Research on AIDS and Viral Hepatitis at 9 sites in Côte d’Ivoire.
Trial summary
The Temprano trial is based on the following assumptions: ART initiation at CD4 counts <800/mm3 could significantly reduce the probability of severe HIV-related morbidity or death in the medium term. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- Antiretroviral medications and Antiretroviral medications+Isoniazid prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,073 participants
- Where
- 9 sitesCôte d’Ivoire
- Study dates
- Mar 2008to Jan 2015
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 or HIV-1 + HIV-2 infection
- Age >18 years
- No ongoing active tuberculosis
- Home address in any district of the greater Abidjan area
- Written informed consent before any clinic visit or laboratory test
- Clinical and immunologic status:CD4 counts <800/mm3 and no criteria for starting ART according to the most recent WHO guidelines
Who cannot join
- Pregnant or breastfeeding women
- HIV-2 infection alone
- Clinical signs suggesting a severe disease (including tuberculosis) that has not yet been diagnosed, such as fever, wasting, diarrhea or unexplained cough (partial list)
- Previous ART initiation
- Known severe renal, cardiac or hepatic disease
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Côte d’Ivoire9 sites
Centre de prise en charge de personnes vivant avec le VIH la pierre angulaire
Abidjan
Centre de Prise en Charge et de Formation ACONDA
Abidjan
Centre de Suivi des donneurs de sang, Centre National de Transfusion Sanguine
Abidjan
Centre Intégré de Recherches Biocliniques d'Abidjan
Abidjan
Centre médico-social El Rapha
Abidjan
Formation Sanitaire Urbaine Anonkoua Kouté
Abidjan
Hopital Général Felix Houphouet Boigny
Abidjan
Service des Maladies Infectieuses et Tropicales, CHU de Treichville
Abidjan
Unité de Soins Ambulatoires et de Conseil, CHU de Treichville
Abidjan
About this study
Official title: Benefits and Risks of Early Antiretroviral Therapy in HIV-infected Adults in Abidjan, Côte d'Ivoire: Randomized Controlled Trial (ANRS 12136 TEMPRANO)
The Temprano trial is based on the following assumptions:
- ART initiation at CD4 counts <800/mm3 could significantly reduce the probability of severe HIV-related morbidity or death in the medium term.
- Tuberculosis and tuberculosis-related deaths are likely to represent a considerable proportion of morbidity and mortality among HIV-infected patients with high CD4 counts in sub-Saharan Africa. Therefore, 6-month Isoniazide Prophylaxis for Tuberculosis (IPT) and early ART could enhance each others efficacy.
Read the detailed description
- The main individual benefit of very early ART initiation is likely a reduction in early severe AIDS-defining and non-AIDS-defining morbidity. While the diseases that might justify earlier initiation in high-income countries are generally non-infectious (non-AIDS-defining malignancies, renal diseases and cardiovascular diseases), the leading cause of early severe AIDS-defining morbidity in sub-Saharan Africa is tuberculosis and the main causes of severe non-AIDS-defining morbidity are non-invasive bacterial diseases. As a result of poor access to diagnosis and care, some HIV-infected people die from early infectious diseases before reaching current WHO criteria for starting ART.
- Although the Côte d'Ivoire National Tuberculosis Program (PNLT) does not authorize the use of prophylaxis against tuberculosis, it has allowed the Temprano trial to provide a six-month course of isoniazid (INH) prophylaxis to half of the study subjects. This will allow us to (i) put early ART in perspective with a early 6-month INH prophylaxis use, in a setting where tuberculosis is the first cause of severe HIV-associated morbidity; and (ii) to describe and assess the feasibility of a six-month course of INH prophylaxis among patients with high CD4 counts.
- Some drug toxicities are immediate but reversible. If early ART is compared to no ART in the short term, these toxicities may demonstrate erroneously that early ART is unfavorable. The risks and benefits of early ART initiation should therefore be evaluated over the long term. In the Temprano trial, we will: (i) follow patients for at least 30 months and analyze the primary outcome at 30 months; (ii) follow some study subjects for 80 months and evaluate the evolution of the ART efficacy / toxicity ratio from month 30 to month 80 as a secondary endpoint, to inform future policies if early ART is found to be beneficial at 30 months.
Main objective: To assess the benefits and risks of starting ART immediately and/or to receive a 6-month IPT among HIV-infected adults with CD4 counts <800mm3 and no criteria for starting ART immediately according to the most recent WHO guidelines.
Location: Abidjan, Côte d'Ivoire.
Methods: randomized 2x2 factorial superiority trial
Main inclusion criteria: (i) HIV-1 or HIV-1+2 infection; (ii) age >18 years; (iii) nadir CD4 count <800/mm3 and no criteria for starting ART immediately according to the most recent WHO guidelines; and (iv) no active tuberculosis.
Trial arms: Arm I: ART initiation according to WHO criteria, at any time during follow-up; Arm II: INH prophylaxis (300 mg/day) for six months and ART initiation according to WHO criteria, at any time during follow-up; Arm III: immediate ART initiation, before reaching the WHO criteria; Arm IV: INH prophylaxis (300 mg/day) for six months and immediate ART initiation, before reaching the WHO criteria.
First-line ART regimens
- Tenofovir / emtricitabine + efavirenz for all HIV-1-infected men and all HIV-1-infected women who meet the following requirements: on effective contraception and no history of nevirapine use for the prevention of mother-to-child transmission of HIV (PMTCT).
- Tenofovir / emtricitabine + lopinavir / ritonavir for all HIV-1+2-infected patients and all women who do not use effective contraception or who have a history of nevirapine use for PMTCT.
Primary endpoint: Death (all-cause), AIDS-defining disease, non-AIDS-defining malignancy, or non-AIDS-defining invasive bacterial disease.
Main secondary endpoint: Grade 3 or 4 clinical event (including renal and cardiovascular events) or laboratory test result, as defined by the ANRS classification system of drug-related adverse events.
Final primary analysis: It will be performed once the last patient has reached 30 months of follow-up. Time-dependent analyses will compare the primary outcome : (i) among patients initiating ART immediately (arms III and IV) versus patients initiating ART according to the WHO criteria (arms I and II); (ii) among patients who were prescribed a 6-months (arms II and IV) IPT versus those who were not (arms I and III).
Intermediate analysis on safety criteria:
- Toxicity: all-cause mortality. We have not planned to perform any intermediate analyses for this criterion. If the number of observed deaths is higher than anticipated, however, the DSMB may decide to carry one out. In this case, we will adjust the alpha coefficient using the method suggested by Pocock to account for the large variety of available tests.
- Efficacy: incidence of severe morbidity. Intermediate analysis: We have not planned any intermediate analyses for this criterion. If the number of severe morbidity evens is higher than anticipated once all patients have reached 12 months of follow-up, the DSMB may decide to carry one out. In this case, we will adjust the alpha coefficient using the method suggested by Haybittle-Peto, to account for the large variety of available tests.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Antiretroviral medications, Antiretroviral medications+Isoniazid prophylaxis
- Keywords
- HIV, HAART, Early Intervention, Naive patients
- 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.
Antiretroviral medicationsDrug
Antiretroviral medications initiation at any time during the trial if at least one WHO-recommended criterion for starting ART is observed.
Antiretroviral medications+Isoniazid prophylaxisDrug
- Antiretroviral initiation at any time during the trial if at least one 2009 WHO-recommended criterion for starting ART is observed.
- Isoniazid prophylaxis:300 mg of INH once a day before breakfast for six months, starting one month after study inclusion
Antiretroviral medicationsDrug
Early ART initiation on the day of inclusion, before reaching the current WHO criteria
Antiretroviral medications+Isoniazid prophylaxisDrug
- Early Antiretroviral medications initiation on the day of inclusion, before reaching the current WHO criteria
- Isoniazid prophylaxis: 300 mg of INH once a day before breakfast for six months, starting one month after study inclusion
| Study group | Role | What they receive |
|---|---|---|
| I | Active comparator | Standard of care Receives: Drug: Antiretroviral medications |
| II | Experimental | Standard of care+Isoniazid Prophylaxis: Receives: Drug: Antiretroviral medications+Isoniazid prophylaxis |
| III | Experimental | Early Antiretroviral therapy Receives: Drug: Antiretroviral medications |
| IV | Experimental | Early Antiretroviral therapy + Isoniazid prophylaxis Receives: Drug: Antiretroviral medications+Isoniazid prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death (all-cause), or severe HIV-related disease (AIDS-defining diseases, non-AIDS-defining malignancies, and non-AIDS-defining invasive bacterial diseases)
- Severe HIV-related disease are defined as AIDS-defining diseases, non-AIDS- defining malignancies, and non-AIDS-defining invasive bacterial diseases
- Invasive bacterial diseases are defined as: bacteremia, or bacterial infection of any solid organ or aseptic cavity (eg: pneumonia, pleurisy, meningitis,pyomyositis, pyelonephritis, prostatitis, orchitis, epididymitis, salpingitis, endometritis, endocarditis, cholecystitis, visceral abscesses).
Measured: 30 months
prevalence of HIV resistance (ANRS12253 associated study)
Measured: 30 month after ARV initiation
Secondary outcomes (10)
Grade 3 or 4 clinical events (including cardiovascular, renal and bone disease) and laboratory test results, as defined by the ANRS classification system of drug-related adverse events
Measured: 30 months
Tuberculosis disease or tuberculosis-related death
Measured: 30 months
Changes in CD4 counts
Measured: 30 months
Resistance to antiretroviral medications
Measured: 30 months
Adherence to treatment
Measured: 30 months
Individual socio-economic factors
Measured: 30 months
Quality of life
Measured: 30 months
Conversions and reversions of repeated QuantiFERON® TB Gold tests between inclusion and month 12 (M12)(ANRS12224 associated study)
Measured: 12 months
Cost-effectiveness of each trial arm in the short- and long-term
Measured: 30 months
Death
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startMar 2008
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- Gilead Sciences, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Xavier Anglaret, MD, PhD, Principal investigator, Université Bordeaux 2Serge Eholié, MD, MSc, Pr, Principal investigator, CHU de Treichville, Abidjan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495651
- Sponsor's protocol ID
- ANRS 12136 TEMPRANO
- Acronym
- TEMPRANO
- Status last verified
- Jun 2015
- First submitted
- 2 Jul 2007
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moh DR, Ntakpe JB, Gabillard D, Yayo-Emieme AA, Badje A, Kouame GM, d'Aquin TT, Danel C, Anglaret X, Eholie SP. Association of cellular HIV-1 DNA and virological success of antiretroviral treatment in HIV-infected sub-Saharan African adults. BMC Infect Dis. 2022 Jan 29;22(1):100. doi: 10.1186/s12879-022-07082-2.
PubMed 35093007Moh R, Badje A, N'takpe JB, Kouame GM, Gabillard D, Ouassa T, Ouattara E, Le Carrou J, Bohoussou F, Messou E, Eholie S, Anglaret X, Danel C. Screening for active tuberculosis before isoniazid preventive therapy among HIV-infected West African adults. Int J Tuberc Lung Dis. 2017 Dec 1;21(12):1237-1244. doi: 10.5588/ijtld.17.0016.
PubMed 29297443Kouame GM, Boyd A, Moh R, Badje A, Gabillard D, Ouattara E, Ntakpe JB, Emieme A, Maylin S, Chekaraou MA, Eholie SP, Zoulim F, Lacombe K, Anglaret X, Danel C; French National Agency for Research on AIDS and Viral Hepatitis (ANRS) 12136 Temprano and ANRS 12240 VarBVA Study Groups. Higher Mortality Despite Early Antiretroviral Therapy in Human Immunodeficiency Virus and Hepatitis B Virus (HBV)-Coinfected Patients With High HBV Replication. Clin Infect Dis. 2018 Jan 6;66(1):112-120. doi: 10.1093/cid/cix747.
PubMed 29020361TEMPRANO ANRS 12136 Study Group; Danel C, Moh R, Gabillard D, Badje A, Le Carrou J, Ouassa T, Ouattara E, Anzian A, Ntakpe JB, Minga A, Kouame GM, Bouhoussou F, Emieme A, Kouame A, Inwoley A, Toni TD, Ahiboh H, Kabran M, Rabe C, Sidibe B, Nzunetu G, Konan R, Gnokoro J, Gouesse P, Messou E, Dohoun L, Kamagate S, Yao A, Amon S, Kouame AB, Koua A, Kouame E, Ndri Y, Ba-Gomis O, Daligou M, Ackoundze S, Hawerlander D, Ani A, Dembele F, Kone F, Guehi C, Kanga C, Koule S, Seri J, Oyebi M, Mbakop N, Makaila O, Babatunde C, Babatounde N, Bleoue G, Tchoutedjem M, Kouadio AC, Sena G, Yededji SY, Assi R, Bakayoko A, Mahassadi A, Attia A, Oussou A, Mobio M, Bamba D, Koman M, Horo A, Deschamps N, Chenal H, Sassan-Morokro M, Konate S, Aka K, Aoussi E, Journot V, Nchot C, Karcher S, Chaix ML, Rouzioux C, Sow PS, Perronne C, Girard PM, Menan H, Bissagnene E, Kadio A, Ettiegne-Traore V, Moh-Semde C, Kouame A, Massumbuko JM, Chene G, Dosso M, Domoua SK, N'Dri-Yoman T, Salamon R, Eholie SP, Anglaret X. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808-22. doi: 10.1056/NEJMoa1507198. Epub 2015 Jul 20.
PubMed 26193126Danel C, Kabran M, Inwoley A, Badje A, Herrmann JL, Moh R, Lecarrou J, Gabillard D, Ntakpe JB, Deschamps N, Ouattara E, Perronne C, Eholie S, Anglaret X. Quantiferon-TB Gold: performance for ruling out active tuberculosis in HIV-infected adults with high CD4 count in Cote d'Ivoire, West Africa. PLoS One. 2014 Oct 16;9(10):e107245. doi: 10.1371/journal.pone.0107245. eCollection 2014.
PubMed 25330161Jean K, Gabillard D, Moh R, Danel C, Desgrees-du-Lou A, N'takpe JB, Le Carrou J, Badje A, Eholie S, Lert F, Anglaret X, Dray-Spira R. Decrease in sexual risk behaviours after early initiation of antiretroviral therapy: a 24-month prospective study in Cote d'Ivoire. J Int AIDS Soc. 2014 Jun 30;17(1):18977. doi: 10.7448/IAS.17.1.18977. eCollection 2014.
PubMed 24985779Ouattara E, Danel C, Moh R, Gabillard D, Peytavin G, Konan R, Carrou JL, Bohoussou F, Eholie SP, Anglaret X. Early upper digestive tract side effects of zidovudine with tenofovir plus emtricitabine in West African adults with high CD4 counts. J Int AIDS Soc. 2013 Apr 30;16(1):18059. doi: 10.7448/IAS.16.1.18059.
PubMed 23639243
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits and Risks of Early Antiretroviral Therapy in HIV-infected Adults in Abidjan, Côte d'Ivoire: Randomized Controlled Trial (ANRS 12136 TEMPRANO)
- ClinicalTrials.gov ID
- NCT00495651
- Acronym / sponsor ID
- TEMPRANO / ANRS 12136 TEMPRANO
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- HIV, HAART, Early Intervention, Naive patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,073 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- Gilead Sciences, Merck Sharp & Dohme LLC
- Study start
- Mar 2008
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Jul 2007 (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.
The Temprano trial is based on the following assumptions:
- ART initiation at CD4 counts <800/mm3 could significantly reduce the probability of severe HIV-related morbidity or death in the medium term.
- Tuberculosis and tuberculosis-related deaths are likely to represent a considerable proportion of morbidity and mortality among HIV-infected patients with high CD4 counts in sub-Saharan Africa. Therefore, 6-month Isoniazide Prophylaxis for Tuberculosis (IPT) and early ART could enhance each others efficacy.
Detailed description
- The main individual benefit of very early ART initiation is likely a reduction in early severe AIDS-defining and non-AIDS-defining morbidity. While the diseases that might justify earlier initiation in high-income countries are generally non-infectious (non-AIDS-defining malignancies, renal diseases and cardiovascular diseases), the leading cause of early severe AIDS-defining morbidity in sub-Saharan Africa is tuberculosis and the main causes of severe non-AIDS-defining morbidity are non-invasive bacterial diseases. As a result of poor access to diagnosis and care, some HIV-infected people die from early infectious diseases before reaching current WHO criteria for starting ART.
- Although the Côte d'Ivoire National Tuberculosis Program (PNLT) does not authorize the use of prophylaxis against tuberculosis, it has allowed the Temprano trial to provide a six-month course of isoniazid (INH) prophylaxis to half of the study subjects. This will allow us to (i) put early ART in perspective with a early 6-month INH prophylaxis use, in a setting where tuberculosis is the first cause of severe HIV-associated morbidity; and (ii) to describe and assess the feasibility of a six-month course of INH prophylaxis among patients with high CD4 counts.
- Some drug toxicities are immediate but reversible. If early ART is compared to no ART in the short term, these toxicities may demonstrate erroneously that early ART is unfavorable. The risks and benefits of early ART initiation should therefore be evaluated over the long term. In the Temprano trial, we will: (i) follow patients for at least 30 months and analyze the primary outcome at 30 months; (ii) follow some study subjects for 80 months and evaluate the evolution of the ART efficacy / toxicity ratio from month 30 to month 80 as a secondary endpoint, to inform future policies if early ART is found to be beneficial at 30 months.
Main objective: To assess the benefits and risks of starting ART immediately and/or to receive a 6-month IPT among HIV-infected adults with CD4 counts <800mm3 and no criteria for starting ART immediately according to the most recent WHO guidelines.
Location: Abidjan, Côte d'Ivoire.
Methods: randomized 2x2 factorial superiority trial
Main inclusion criteria: (i) HIV-1 or HIV-1+2 infection; (ii) age >18 years; (iii) nadir CD4 count <800/mm3 and no criteria for starting ART immediately according to the most recent WHO guidelines; and (iv) no active tuberculosis.
Trial arms: Arm I: ART initiation according to WHO criteria, at any time during follow-up; Arm II: INH prophylaxis (300 mg/day) for six months and ART initiation according to WHO criteria, at any time during follow-up; Arm III: immediate ART initiation, before reaching the WHO criteria; Arm IV: INH prophylaxis (300 mg/day) for six months and immediate ART initiation, before reaching the WHO criteria.
First-line ART regimens
- Tenofovir / emtricitabine + efavirenz for all HIV-1-infected men and all HIV-1-infected women who meet the following requirements: on effective contraception and no history of nevirapine use for the prevention of mother-to-child transmission of HIV (PMTCT).
- Tenofovir / emtricitabine + lopinavir / ritonavir for all HIV-1+2-infected patients and all women who do not use effective contraception or who have a history of nevirapine use for PMTCT.
Primary endpoint: Death (all-cause), AIDS-defining disease, non-AIDS-defining malignancy, or non-AIDS-defining invasive bacterial disease.
Main secondary endpoint: Grade 3 or 4 clinical event (including renal and cardiovascular events) or laboratory test result, as defined by the ANRS classification system of drug-related adverse events.
Final primary analysis: It will be performed once the last patient has reached 30 months of follow-up. Time-dependent analyses will compare the primary outcome : (i) among patients initiating ART immediately (arms III and IV) versus patients initiating ART according to the WHO criteria (arms I and II); (ii) among patients who were prescribed a 6-months (arms II and IV) IPT versus those who were not (arms I and III).
Intermediate analysis on safety criteria:
- Toxicity: all-cause mortality. We have not planned to perform any intermediate analyses for this criterion. If the number of observed deaths is higher than anticipated, however, the DSMB may decide to carry one out. In this case, we will adjust the alpha coefficient using the method suggested by Pocock to account for the large variety of available tests.
- Efficacy: incidence of severe morbidity. Intermediate analysis: We have not planned any intermediate analyses for this criterion. If the number of severe morbidity evens is higher than anticipated once all patients have reached 12 months of follow-up, the DSMB may decide to carry one out. In this case, we will adjust the alpha coefficient using the method suggested by Haybittle-Peto, to account for the large variety of available tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| I | Active comparator | Drug: Antiretroviral medicationsStandard of care |
| II | Experimental | Drug: Antiretroviral medications+Isoniazid prophylaxisStandard of care+Isoniazid Prophylaxis: |
| III | Experimental | Drug: Antiretroviral medicationsEarly Antiretroviral therapy |
| IV | Experimental | Drug: Antiretroviral medications+Isoniazid prophylaxisEarly Antiretroviral therapy + Isoniazid prophylaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HIV-1 or HIV-1 + HIV-2 infection
- Age >18 years
- No ongoing active tuberculosis
- Home address in any district of the greater Abidjan area
- Written informed consent before any clinic visit or laboratory test
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women
- HIV-2 infection alone
- Clinical signs suggesting a severe disease (including tuberculosis) that has not yet been diagnosed, such as fever, wasting, diarrhea or unexplained cough (partial list)
- Previous ART initiation
- Known severe renal, cardiac or hepatic disease
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 |
|---|---|---|
| Antiretroviral medicationsAntiretroviral medications initiation at any time during the trial if at least one WHO-recommended criterion for starting ART is observed. | Drug | I |
| Antiretroviral medications+Isoniazid prophylaxis* Antiretroviral initiation at any time during the trial if at least one 2009 WHO-recommended criterion for starting ART is observed. * Isoniazid prophylaxis:300 mg of INH once a day before breakfast for six months, starting one month after study inclusion | Drug | II |
| Antiretroviral medicationsEarly ART initiation on the day of inclusion, before reaching the current WHO criteria | Drug | III |
| Antiretroviral medications+Isoniazid prophylaxis* Early Antiretroviral medications initiation on the day of inclusion, before reaching the current WHO criteria * Isoniazid prophylaxis: 300 mg of INH once a day before breakfast for six months, starting one month after study inclusion | Drug | IV |
Primary outcome
Death (all-cause), or severe HIV-related disease (AIDS-defining diseases, non-AIDS-defining malignancies, and non-AIDS-defining invasive bacterial diseases)
Time frame: 30 months
* Severe HIV-related disease are defined as AIDS-defining diseases, non-AIDS- defining malignancies, and non-AIDS-defining invasive bacterial diseases * Invasive bacterial diseases are defined as: bacteremia, or bacterial infection of any solid organ or aseptic cavity (eg: pneumonia, pleurisy, meningitis,pyomyositis, pyelonephritis, prostatitis, orchitis, epididymitis, salpingitis, endometritis, endocarditis, cholecystitis, visceral abscesses).
prevalence of HIV resistance (ANRS12253 associated study)
Time frame: 30 month after ARV initiation
10 secondary outcomes
Grade 3 or 4 clinical events (including cardiovascular, renal and bone disease) and laboratory test results, as defined by the ANRS classification system of drug-related adverse events
Time frame: 30 months
Tuberculosis disease or tuberculosis-related death
Time frame: 30 months
Changes in CD4 counts
Time frame: 30 months
Resistance to antiretroviral medications
Time frame: 30 months
Adherence to treatment
Time frame: 30 months
Individual socio-economic factors
Time frame: 30 months
Quality of life
Time frame: 30 months
Conversions and reversions of repeated QuantiFERON® TB Gold tests between inclusion and month 12 (M12)(ANRS12224 associated study)
Time frame: 12 months
Cost-effectiveness of each trial arm in the short- and long-term
Time frame: 30 months
Death
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Derived from this study: PubMed 35093007Moh DR, Ntakpe JB, Gabillard D, Yayo-Emieme AA, Badje A, Kouame GM, d'Aquin TT, Danel C, Anglaret X, Eholie SP. Association of cellular HIV-1 DNA and virological success of antiretroviral treatment in HIV-infected sub-Saharan African adults. BMC Infect Dis. 2022 Jan 29;22(1):100. doi: 10.1186/s12879-022-07082-2.
- Derived from this study: PubMed 29297443Moh R, Badje A, N'takpe JB, Kouame GM, Gabillard D, Ouassa T, Ouattara E, Le Carrou J, Bohoussou F, Messou E, Eholie S, Anglaret X, Danel C. Screening for active tuberculosis before isoniazid preventive therapy among HIV-infected West African adults. Int J Tuberc Lung Dis. 2017 Dec 1;21(12):1237-1244. doi: 10.5588/ijtld.17.0016.
- Derived from this study: PubMed 29020361Kouame GM, Boyd A, Moh R, Badje A, Gabillard D, Ouattara E, Ntakpe JB, Emieme A, Maylin S, Chekaraou MA, Eholie SP, Zoulim F, Lacombe K, Anglaret X, Danel C; French National Agency for Research on AIDS and Viral Hepatitis (ANRS) 12136 Temprano and ANRS 12240 VarBVA Study Groups. Higher Mortality Despite Early Antiretroviral Therapy in Human Immunodeficiency Virus and Hepatitis B Virus (HBV)-Coinfected Patients With High HBV Replication. Clin Infect Dis. 2018 Jan 6;66(1):112-120. doi: 10.1093/cid/cix747.
- Derived from this study: PubMed 26193126TEMPRANO ANRS 12136 Study Group; Danel C, Moh R, Gabillard D, Badje A, Le Carrou J, Ouassa T, Ouattara E, Anzian A, Ntakpe JB, Minga A, Kouame GM, Bouhoussou F, Emieme A, Kouame A, Inwoley A, Toni TD, Ahiboh H, Kabran M, Rabe C, Sidibe B, Nzunetu G, Konan R, Gnokoro J, Gouesse P, Messou E, Dohoun L, Kamagate S, Yao A, Amon S, Kouame AB, Koua A, Kouame E, Ndri Y, Ba-Gomis O, Daligou M, Ackoundze S, Hawerlander D, Ani A, Dembele F, Kone F, Guehi C, Kanga C, Koule S, Seri J, Oyebi M, Mbakop N, Makaila O, Babatunde C, Babatounde N, Bleoue G, Tchoutedjem M, Kouadio AC, Sena G, Yededji SY, Assi R, Bakayoko A, Mahassadi A, Attia A, Oussou A, Mobio M, Bamba D, Koman M, Horo A, Deschamps N, Chenal H, Sassan-Morokro M, Konate S, Aka K, Aoussi E, Journot V, Nchot C, Karcher S, Chaix ML, Rouzioux C, Sow PS, Perronne C, Girard PM, Menan H, Bissagnene E, Kadio A, Ettiegne-Traore V, Moh-Semde C, Kouame A, Massumbuko JM, Chene G, Dosso M, Domoua SK, N'Dri-Yoman T, Salamon R, Eholie SP, Anglaret X. A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa. N Engl J Med. 2015 Aug 27;373(9):808-22. doi: 10.1056/NEJMoa1507198. Epub 2015 Jul 20.
- Derived from this study: PubMed 25330161Danel C, Kabran M, Inwoley A, Badje A, Herrmann JL, Moh R, Lecarrou J, Gabillard D, Ntakpe JB, Deschamps N, Ouattara E, Perronne C, Eholie S, Anglaret X. Quantiferon-TB Gold: performance for ruling out active tuberculosis in HIV-infected adults with high CD4 count in Cote d'Ivoire, West Africa. PLoS One. 2014 Oct 16;9(10):e107245. doi: 10.1371/journal.pone.0107245. eCollection 2014.
- Derived from this study: PubMed 24985779Jean K, Gabillard D, Moh R, Danel C, Desgrees-du-Lou A, N'takpe JB, Le Carrou J, Badje A, Eholie S, Lert F, Anglaret X, Dray-Spira R. Decrease in sexual risk behaviours after early initiation of antiretroviral therapy: a 24-month prospective study in Cote d'Ivoire. J Int AIDS Soc. 2014 Jun 30;17(1):18977. doi: 10.7448/IAS.17.1.18977. eCollection 2014.
- Derived from this study: PubMed 23639243Ouattara E, Danel C, Moh R, Gabillard D, Peytavin G, Konan R, Carrou JL, Bohoussou F, Eholie SP, Anglaret X. Early upper digestive tract side effects of zidovudine with tenofovir plus emtricitabine in West African adults with high CD4 counts. J Int AIDS Soc. 2013 Apr 30;16(1):18059. doi: 10.7448/IAS.16.1.18059.
- Related InfoLink provided by the sponsor.
- ANRS 12136 Temprano trial websiteLink provided by the sponsor.
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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.
Xavier Anglaret, MD, PhD principal investigator
Université Bordeaux 2
Serge Eholié, MD, MSc, Pr principal investigator
CHU de Treichville, Abidjan
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antiretroviral medications and Antiretroviral medications+Isoniazid prophylaxis in people with HIV Infections and Tuberculosis, run by French National Agency for Research on AIDS and Viral Hepatitis at 9 sites in Côte d’Ivoire.
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 5 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: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Côte d’Ivoire. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (all-cause), or severe HIV-related disease (AIDS-defining diseases, non-AIDS-defining malignancies, and non-AIDS-defining invasive bacterial diseases) (time frame: 30 months). The study lists 2 primary outcomes in all. 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 NCT00495651, which also lists 7 linked publications.
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 3 Jun 2015.