HIV InfectionPhase 3NCT00226434
Early vs Late Introduction of Antiretroviral Therapy in HIV-infected Patients With Tuberculosis (ANRS 1295 CAMELIA)
A Phase 3 study testing Early antiretroviral treatment and Late antiretroviral treatment in people with HIV Infection and Tuberculosis, run by French National Agency for Research on AIDS and Viral Hepatitis at 5 sites in Cambodia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Tuberculosis
- What is being tested?
- Early antiretroviral treatment and Late antiretroviral treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 661 participants
- Where
- 5 sitesCambodia
- Study dates
- Jan 2006to May 2010
- 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
- Age 18 or over
- Positive HIV test result
- CD4+ cell count under or equal to 200 cells per ml within 14 days prior the study entry
- Positive AFB on any smear (sputum, lymph node drainage, stool, CSF, pleural fluid)
- Naive to ART
- TB treatment started less than one week prior enrolment
- Negative gonadotrophin pregnancy test (blood) for women of childbearing potential (i.e. not surgically sterile or less than 2 years menopause)
- Agreement from female candidates who are participating in sexual activity that could lead to pregnancy while receiving and for 6 weeks after stopping efavirenz to use two reliable methods of contraception, one of which including condom.
Who cannot join
- Suspected TB with negative AFB
- Pregnant or breastfeeding women
- Impaired hepatic function (icterus, elevated AST or ALT at least 5 times over the normal value)
- Unable and/or unlikely to comprehend and/or be adherent to the protocol
- Treated for a previous suspected or documented TB other than the ongoing infection which motivates enrolment in this trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Cambodia5 sites
Calmette Hospital
Phnom Penh
Khmero-Soviet Friendship Hospital
Phnom Penh
Siem Reap Referral Hospital
Siem Reap
Provincial hospital
Svay Rieng
Provincial hospital
Takeo
About this study
Official title: Early vs Late Introduction of Antiretroviral Therapy in Naive HIV-infected Patients With Tuberculosis in Cambodia
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.
Read the detailed description
In Cambodia the prevalence of both tuberculosis (TB) and Human Immunodeficiency Virus (HIV) infection is high. In 2000, there were approximately 75.000 newly diagnosed TB cases. In 2003, 1.9% 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 cells/l).
Mortality rates were found to be 2-4 folds higher in HIV/TB 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 HIV/TB 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 cells/l 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.
- Conditions
- HIV Infection, Tuberculosis
- Being tested
- Early antiretroviral treatment, Late antiretroviral treatment
- Keywords
- HIV infection, Tuberculosis, Paradoxical reaction, Treatment Naive
- 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.
Early antiretroviral treatmentProcedure or surgery
The ARV treatment is started 2 weeks after the diagnosis and the start of the anti-tuberculosis treatment
Late antiretroviral treatmentProcedure or surgery
The ARV treatment is started 8 weeks after the diagnosis and the start of the anti-tuberculosis treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Early antiretroviral treatment |
| 2 | Active comparator | Not described Receives: Procedure: Late antiretroviral treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: At the end of the study
Secondary outcomes (10)
Type, frequency and severity of Adverse Events that occur during the trial and to their potential relations with the drugs, HIV or TB infection
Measured: During the overall study
Frequency of Immune Reconstitution Inflammatory Syndrome
Measured: During the overall study
Frequency of TB paradoxical reaction, defined as worsening or emergence of signs or symptoms of TB (e.g. fever, cough, shortness of breath, adenopathy or exacerbation of disease at other extra pulmonary sites) during appropriate TB treatment
Measured: During the overall study
Occurrence of opportunistic infections
Measured: During the overall study
Evaluation of TB treatment success
Measured: During the overall study
Evaluation of ART treatment success
Measured: During the overall study
Resistance to ARV treatment determined by genotyping HIV-1 strains among patients with detectable viral load on Day 0 and Week 50
Measured: Within 12 months of follow-up
Patient's adherence to TB and ARV treatment evaluated based on interviews and pill counts at each study visit
Measured: During the overall study
Pharmacokinetic study to assess efavirenz plasma exposure will be assayed at regular time intervals
Measured: Within 12 months of follow-up
Survival Rate
Measured: 50 weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startJan 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 661 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- François-Xavier Blanc, Principal investigator, Bicêtre University Hospital, FranceThim Sok, Principal investigator, Cambodian Health Committee, Phnom Penh, CambodiaAnne Goldfeld, Principal investigator, Institute for Biomedical Research, Boston, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226434
- Sponsor's protocol ID
- ANRS 1295 CAMELIA
- Other IDs
- CIPRA KH 001
- Status last verified
- Mar 2012
- First submitted
- 23 Sep 2005
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blanc FX, Havlir DV, Onyebujoh PC, Thim S, Goldfeld AE, Delfraissy JF. Treatment strategies for HIV-infected patients with tuberculosis: ongoing and planned clinical trials. J Infect Dis. 2007 Aug 15;196 Suppl 1:S46-51. doi: 10.1086/518658.
PubMed 17624825Marcy O, Laureillard D, Madec Y, Chan S, Mayaud C, Borand L, Prak N, Kim C, Lak KK, Hak C, Dim B, Sok T, Delfraissy JF, Goldfeld AE, Blanc FX; CAMELIA (ANRS 1295-CIPRA KH001) Study Team. Causes and determinants of mortality in HIV-infected adults with tuberculosis: an analysis from the CAMELIA ANRS 1295-CIPRA KH001 randomized trial. Clin Infect Dis. 2014 Aug 1;59(3):435-45. doi: 10.1093/cid/ciu283. Epub 2014 Apr 23.
PubMed 24759827Borand L, Madec Y, Laureillard D, Chou M, Marcy O, Pheng P, Prak N, Kim C, Lak KK, Hak C, Dim B, Nerrienet E, Fontanet A, Sok T, Goldfeld AE, Blanc FX, Taburet AM. Plasma concentrations, efficacy and safety of efavirenz in HIV-infected adults treated for tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA trial). PLoS One. 2014 Mar 7;9(3):e90350. doi: 10.1371/journal.pone.0090350. eCollection 2014.
PubMed 24608960Laureillard D, Marcy O, Madec Y, Chea S, Chan S, Borand L, Fernandez M, Prak N, Kim C, Dim B, Nerrienet E, Sok T, Delfraissy JF, Goldfeld AE, Blanc FX; CAMELIA (ANRS 1295 - CIPRA KH001) Study Team. Paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome after early initiation of antiretroviral therapy in a randomized clinical trial. AIDS. 2013 Oct 23;27(16):2577-86. doi: 10.1097/01.aids.0000432456.14099.c7.
PubMed 24096631Borand L, Laureillard D, Madec Y, Chou M, Pheng P, Marcy O, Sok T, Goldfeld AE, Taburet AM, Blanc FX; CAMELIA ANRS 1295-CIPRA KH001 Study Team. Plasma concentrations of efavirenz with a 600 mg standard dose in Cambodian HIV-infected adults treated for tuberculosis with a body weight above 50 kg. Antivir Ther. 2013;18(3):419-23. doi: 10.3851/IMP2483. Epub 2012 Dec 12.
PubMed 23237982Blanc FX, Sok T, Laureillard D, Borand L, Rekacewicz C, Nerrienet E, Madec Y, Marcy O, Chan S, Prak N, Kim C, Lak KK, Hak C, Dim B, Sin CI, Sun S, Guillard B, Sar B, Vong S, Fernandez M, Fox L, Delfraissy JF, Goldfeld AE; CAMELIA (ANRS 1295-CIPRA KH001) Study Team. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med. 2011 Oct 20;365(16):1471-81. doi: 10.1056/NEJMoa1013911.
PubMed 22010913
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early vs Late Introduction of Antiretroviral Therapy in Naive HIV-infected Patients With Tuberculosis in Cambodia
- ClinicalTrials.gov ID
- NCT00226434
- Acronym / sponsor ID
- ANRS 1295 CAMELIA
- Conditions
- HIV Infection, Tuberculosis
- Keywords
- HIV infection, Tuberculosis, Paradoxical reaction, Treatment Naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 661 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 Sep 2005 (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.
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.
Detailed description
In Cambodia the prevalence of both tuberculosis (TB) and Human Immunodeficiency Virus (HIV) infection is high. In 2000, there were approximately 75.000 newly diagnosed TB cases. In 2003, 1.9% 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 cells/l).
Mortality rates were found to be 2-4 folds higher in HIV/TB 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 HIV/TB 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 cells/l 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Early antiretroviral treatment |
| 2 | Active comparator | Procedure: Late antiretroviral treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 or over
- Positive HIV test result
- CD4+ cell count under or equal to 200 cells per ml within 14 days prior the study entry
- Positive AFB on any smear (sputum, lymph node drainage, stool, CSF, pleural fluid)
- Naive to ART
Key exclusion criteria (5 listed)
- Suspected TB with negative AFB
- Pregnant or breastfeeding women
- Impaired hepatic function (icterus, elevated AST or ALT at least 5 times over the normal value)
- Unable and/or unlikely to comprehend and/or be adherent to the protocol
- Treated for a previous suspected or documented TB other than the ongoing infection which motivates enrolment in this trial
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 |
|---|---|---|
| Early antiretroviral treatmentThe ARV treatment is started 2 weeks after the diagnosis and the start of the anti-tuberculosis treatment | Procedure or surgery | 1 |
| Late antiretroviral treatmentThe ARV treatment is started 8 weeks after the diagnosis and the start of the anti-tuberculosis treatment | Procedure or surgery | 2 |
Primary outcome
Survival rate
Time frame: At the end of the study
10 secondary outcomes
Type, frequency and severity of Adverse Events that occur during the trial and to their potential relations with the drugs, HIV or TB infection
Time frame: During the overall study
Frequency of Immune Reconstitution Inflammatory Syndrome
Time frame: During the overall study
Frequency of TB paradoxical reaction, defined as worsening or emergence of signs or symptoms of TB (e.g. fever, cough, shortness of breath, adenopathy or exacerbation of disease at other extra pulmonary sites) during appropriate TB treatment
Time frame: During the overall study
Occurrence of opportunistic infections
Time frame: During the overall study
Evaluation of TB treatment success
Time frame: During the overall study
Evaluation of ART treatment success
Time frame: During the overall study
Resistance to ARV treatment determined by genotyping HIV-1 strains among patients with detectable viral load on Day 0 and Week 50
Time frame: Within 12 months of follow-up
Patient's adherence to TB and ARV treatment evaluated based on interviews and pill counts at each study visit
Time frame: During the overall study
Pharmacokinetic study to assess efavirenz plasma exposure will be assayed at regular time intervals
Time frame: Within 12 months of follow-up
Survival Rate
Time frame: 50 weeks after enrolment
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 16 Mar 2012.
- Background: PubMed 17624825Blanc FX, Havlir DV, Onyebujoh PC, Thim S, Goldfeld AE, Delfraissy JF. Treatment strategies for HIV-infected patients with tuberculosis: ongoing and planned clinical trials. J Infect Dis. 2007 Aug 15;196 Suppl 1:S46-51. doi: 10.1086/518658.
- Derived from this study: PubMed 24759827Marcy O, Laureillard D, Madec Y, Chan S, Mayaud C, Borand L, Prak N, Kim C, Lak KK, Hak C, Dim B, Sok T, Delfraissy JF, Goldfeld AE, Blanc FX; CAMELIA (ANRS 1295-CIPRA KH001) Study Team. Causes and determinants of mortality in HIV-infected adults with tuberculosis: an analysis from the CAMELIA ANRS 1295-CIPRA KH001 randomized trial. Clin Infect Dis. 2014 Aug 1;59(3):435-45. doi: 10.1093/cid/ciu283. Epub 2014 Apr 23.
- Derived from this study: PubMed 24608960Borand L, Madec Y, Laureillard D, Chou M, Marcy O, Pheng P, Prak N, Kim C, Lak KK, Hak C, Dim B, Nerrienet E, Fontanet A, Sok T, Goldfeld AE, Blanc FX, Taburet AM. Plasma concentrations, efficacy and safety of efavirenz in HIV-infected adults treated for tuberculosis in Cambodia (ANRS 1295-CIPRA KH001 CAMELIA trial). PLoS One. 2014 Mar 7;9(3):e90350. doi: 10.1371/journal.pone.0090350. eCollection 2014.
- Derived from this study: PubMed 24096631Laureillard D, Marcy O, Madec Y, Chea S, Chan S, Borand L, Fernandez M, Prak N, Kim C, Dim B, Nerrienet E, Sok T, Delfraissy JF, Goldfeld AE, Blanc FX; CAMELIA (ANRS 1295 - CIPRA KH001) Study Team. Paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome after early initiation of antiretroviral therapy in a randomized clinical trial. AIDS. 2013 Oct 23;27(16):2577-86. doi: 10.1097/01.aids.0000432456.14099.c7.
- Derived from this study: PubMed 23237982Borand L, Laureillard D, Madec Y, Chou M, Pheng P, Marcy O, Sok T, Goldfeld AE, Taburet AM, Blanc FX; CAMELIA ANRS 1295-CIPRA KH001 Study Team. Plasma concentrations of efavirenz with a 600 mg standard dose in Cambodian HIV-infected adults treated for tuberculosis with a body weight above 50 kg. Antivir Ther. 2013;18(3):419-23. doi: 10.3851/IMP2483. Epub 2012 Dec 12.
- Derived from this study: PubMed 22010913Blanc FX, Sok T, Laureillard D, Borand L, Rekacewicz C, Nerrienet E, Madec Y, Marcy O, Chan S, Prak N, Kim C, Lak KK, Hak C, Dim B, Sin CI, Sun S, Guillard B, Sar B, Vong S, Fernandez M, Fox L, Delfraissy JF, Goldfeld AE; CAMELIA (ANRS 1295-CIPRA KH001) Study Team. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med. 2011 Oct 20;365(16):1471-81. doi: 10.1056/NEJMoa1013911.
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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.
François-Xavier Blanc principal investigator
Bicêtre University Hospital, France
Thim Sok principal investigator
Cambodian Health Committee, Phnom Penh, Cambodia
Anne Goldfeld principal investigator
Institute for Biomedical Research, Boston, USA
5 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 Early antiretroviral treatment and Late antiretroviral treatment in people with HIV Infection and Tuberculosis, run by French National Agency for Research on AIDS and Viral Hepatitis at 5 sites in Cambodia.
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 8 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 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Cambodia. 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?
Survival rate (time frame: At the end of the study). 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 NCT00226434, which also lists 6 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 16 Mar 2012.