HIV InfectionsNCT00120510
Early Versus Standard Start of Anti-HIV Therapy for Treatment-Naive Adults in Haiti
A study testing Efavirenz and Lamivudine/Zidovudine in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Haiti.
Trial summary
Anti-HIV treatment consisting of lamivudine/zidovudine (3TC/ZDV) and efavirenz (EFV) is the current standard of care for initial treatment of HIV in most areas of the world. The purpose of this study is to determine the best time to start this anti-HIV treatment in treatment-naive adults in Haiti. 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?
- Efavirenz and Lamivudine/Zidovudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 816 participants
- Where
- 1 siteHaiti
- Study dates
- Jul 2007to Sep 2009
- Phase
- Interventional
- 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-infected
- Received pre- and post-test counseling at the GHESKIO Centers
- CD4 count between 200 and 350 cells/mm3
- World Health Organization (WHO) Stage I, II, or III HIV disease
- Willing to use acceptable forms of contraception
Who cannot join
- WHO Stage IV HIV disease (AIDS)
- 7 or more days of cumulative ART prior to study entry OR on ART at time of study entry
- Active TB, if diagnostic work-up for TB is incomplete OR if decision to treat TB has not been made. More information on this criterion can be found in the protocol.
- Recurrent active TB OR history of interrupted or incomplete TB therapy. More information on this criterion can be found in the protocol.
- Has not been evaluated for latent TB and decision to treat latent TB with isoniazid has not been made. More information on this criterion can be found in the protocol.
- Requires ART in the next 3 months, in the opinion of the investigator
Show all 15Show fewer
- Other serious medical illness requiring chronic maintenance therapy (e.g., hypertension, diabetes) UNLESS the individual has completed at least 14 days of therapy prior to study enrollment AND is clinically stable
- Any psychological condition (e.g., severe depression, schizophrenia) that, in the opinion of the investigator, may interfere with the study
- Any social condition (e.g., pending emigration, pending incarceration) that, in the opinion of the investigator, may interfere with the study
- Active drug or alcohol use that, in the opinion of the investigator, may interfere with the study
- Current inflammation of the pancreas
- Allergy/sensitivity to any of study drugs or their formulations
- Requires certain medications
- Enrolled in another therapeutic or interventional clinical trial
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial to Determine the Efficacy of Early Versus Standard Antiretroviral Therapy in HIV Infected Adults With CD4+ T Cell Counts Between 200 and 350 Cells/mm3
Anti-HIV treatment consisting of lamivudine/zidovudine (3TC/ZDV) and efavirenz (EFV) is the current standard of care for initial treatment of HIV in most areas of the world. The purpose of this study is to determine the best time to start this anti-HIV treatment in treatment-naive adults in Haiti.
Read the detailed description
In many parts of the world, initial standard of care for HIV includes 3TC/ZDV and the non-nucleoside reverse transcriptase inhibitor EFV. However, it is unclear if early (CD4 count less than 350 cells/mm3) or delayed (CD4 count less than 200 cells/mm3) therapy initiation leads to improved survival. This study will determine the most appropriate time to initiate ART in HIV infected individuals in Haiti. The study will enroll patients from the Haitian Study Group on Kaposi's Sarcoma and Opportunistic Infections (GHESKIO) Centers. Some participants in this study will have active pulmonary tuberculosis (TB).
This study will last at least 3 years. Participants will be randomly assigned to one of two groups at study entry. Group A participants will receive 3TC/ZDV twice daily and EFV once daily at study enrollment. Participants receiving TB therapy at the time of enrollment may be observed for 2 weeks prior to beginning early therapy. Dosage adjustment of EFV may be necessary for participants receiving rifampin as part of their TB therapy. Group B participants will receive 3TC/ZDV twice daily and EFV once daily when they develop clinical AIDS or their CD4 count drops below 200 cells/mm3 (WHO Stage IV). Directly observed therapy will be used for the first two months of treatment for every participant.
Group A participants will have 14 study visits after beginning treatment; the visits will occur at Months 1, 2, 3, and every 3 months thereafter. Medical and medication history, physical exams, and contraceptive counseling for women will occur at all visits. HIV counseling, blood collection, and HIV staging will occur at most visits. At some study visits, Group A participants will be asked to complete quality of life and adherence questionnaires. Group B participants will have 14 study visits after study entry and will begin treatment when they meet WHO criteria. Assessments will be the same as for Group A. Any participant who fails the first-line regimen during the study will switch to a second-line ART regimen.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Efavirenz, Lamivudine/Zidovudine
- Keywords
- Treatment Naive, TB
- 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.
EfavirenzDrug
Also called EFV
Non-nucleoside reverse transcriptase inhibitor dosed at 600mg taken by mouth every 24 hours at bedtime
Lamivudine/ZidovudineDrug
Also called 3TC/ZDV, 3TC/AZT
Nucleoside reverse transcriptase inhibitor dosed at 150mg/300mg fixed dose combination taken by mouth every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Randomly assigned group who will start an ART regimen of 3TC/ZDV and EFV twice daily at study entry Receives: Drug: Efavirenz; Drug: Lamivudine/Zidovudine |
| B | Active comparator | Randomly assigned group who will delay beginning ART regimen of 3TC/ZDV and EFC twice daily until they develop clinical AIDS or their CD4 count drops below 200 cells/mm3 Receives: Drug: Efavirenz; Drug: Lamivudine/Zidovudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: At 36 months
Secondary outcomes (9)
Safety and drug-associated side effects and toxicities of the study drugs
Measured: Throughout study
Pattern and frequency of antiretroviral drug resistance during ART
Measured: Throughout study
Occurrence and clinical outcome of opportunistic infections, viral coinfections, and immune reconstitution syndromes observed during ART
Measured: Throughout study
TB treatment outcomes in patients with active pulmonary TB at enrollment
Measured: Throughout study
Quality of life scores based on self-report questionnaires
Measured: Throughout study
Adherence based on self-report questionnaires and dosage count
Measured: Throughout study
Cost of therapy
Measured: Throughout study
Plasma HIV-1 RNA below limits of quantitation after initiating ART
Measured: Every 6 months throughout study
Absolute CD4 cell count change from baseline in subjects who initiate ART
Measured: Every 6 months throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2005 (estimated)
- Study startJul 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 816 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jean William Pape, MD, Principal investigator, Cornell - GHESKIO, Institut de Laboratoire et de Recherches and Division of International Medicine and Infectious Diseases, Cornell UniversityPatrice Severe, MD, Study director, Cornell - GHESKIO, Institut de Laboratoire et de RecherchesDaniel W. Fitzgerald, MD, Study director, Division of International Medicine and Infectious Diseases, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120510
- Sponsor's protocol ID
- CIPRA HT 001
- Other IDs
- 5K24AI051966-03, 10403
- Status last verified
- Oct 2014
- First submitted
- 14 Jul 2005
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blankson JN. Primary HIV-1 infection: to treat or not to treat? AIDS Read. 2005 May;15(5):245-6, 249-51.
PubMed 15900634Duncombe C, Kerr SJ, Ruxrungtham K, Dore GJ, Law MG, Emery S, Lange JM, Phanuphak P, Cooper DA. HIV disease progression in a patient cohort treated via a clinical research network in a resource limited setting. AIDS. 2005 Jan 28;19(2):169-78. doi: 10.1097/00002030-200501280-00009.
PubMed 15668542Pape JW. Tuberculosis and HIV in the Caribbean: approaches to diagnosis, treatment, and prophylaxis. Top HIV Med. 2004 Dec-2005 Jan;12(5):144-9.
PubMed 15647610Teck R, Ascurra O, Gomani P, Manzi M, Pasulani O, Kusamale J, Salaniponi FM, Humblet P, Nunn P, Scano F, Harries AD, Zachariah R. WHO clinical staging of HIV infection and disease, tuberculosis and eligibility for antiretroviral treatment: relationship to CD4 lymphocyte counts. Int J Tuberc Lung Dis. 2005 Mar;9(3):258-62.
PubMed 15786887Thorner A, Rosenberg E. Early versus delayed antiretroviral therapy in patients with HIV infection : a review of the current guidelines from an immunological perspective. Drugs. 2003;63(13):1325-37. doi: 10.2165/00003495-200363130-00001.
PubMed 12825959Joseph Y, Yao Z, Dua A, Severe P, Collins SE, Bang H, Antoine Jean-Juste M, Ocheretina O, Apollon A, McNairy ML, Dupnik K, Cremieux E, Byrne A, Pape JW, Koenig SP. Long-term mortality after tuberculosis treatment among persons living with HIV in Haiti. J Int AIDS Soc. 2021 Jul;24(7):e25721. doi: 10.1002/jia2.25721.
PubMed 34235862Collins SE, Jean Juste MA, Koenig SP, Secours R, Ocheretina O, Bernard D, Riviere C, Calnan M, Dunning A, Hurtado Rua SM, Johnson WD Jr, Pape JW, Fitzgerald DW, Severe P. CD4 deficit and tuberculosis risk persist with delayed antiretroviral therapy: 5-year data from CIPRA HT-001. Int J Tuberc Lung Dis. 2015 Jan;19(1):50-7. doi: 10.5588/ijtld.14.0217.
PubMed 25519790Haas DW, Severe P, Jean Juste MA, Pape JW, Fitzgerald DW. Functional CYP2B6 variants and virologic response to an efavirenz-containing regimen in Port-au-Prince, Haiti. J Antimicrob Chemother. 2014 Aug;69(8):2187-90. doi: 10.1093/jac/dku088. Epub 2014 Apr 2.
PubMed 24695352Koenig SP, Bang H, Severe P, Jean Juste MA, Ambroise A, Edwards A, Hippolyte J, Fitzgerald DW, McGreevy J, Riviere C, Marcelin S, Secours R, Johnson WD, Pape JW, Schackman BR. Cost-effectiveness of early versus standard antiretroviral therapy in HIV-infected adults in Haiti. PLoS Med. 2011 Sep;8(9):e1001095. doi: 10.1371/journal.pmed.1001095. Epub 2011 Sep 20.
PubMed 21949643Severe P, Juste MA, Ambroise A, Eliacin L, Marchand C, Apollon S, Edwards A, Bang H, Nicotera J, Godfrey C, Gulick RM, Johnson WD Jr, Pape JW, Fitzgerald DW. Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. N Engl J Med. 2010 Jul 15;363(3):257-65. doi: 10.1056/NEJMoa0910370.
PubMed 20647201
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial to Determine the Efficacy of Early Versus Standard Antiretroviral Therapy in HIV Infected Adults With CD4+ T Cell Counts Between 200 and 350 Cells/mm3
- ClinicalTrials.gov ID
- NCT00120510
- Acronym / sponsor ID
- CIPRA HT 001
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- Treatment Naive, TB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jul 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Jul 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.
Anti-HIV treatment consisting of lamivudine/zidovudine (3TC/ZDV) and efavirenz (EFV) is the current standard of care for initial treatment of HIV in most areas of the world. The purpose of this study is to determine the best time to start this anti-HIV treatment in treatment-naive adults in Haiti.
Detailed description
In many parts of the world, initial standard of care for HIV includes 3TC/ZDV and the non-nucleoside reverse transcriptase inhibitor EFV. However, it is unclear if early (CD4 count less than 350 cells/mm3) or delayed (CD4 count less than 200 cells/mm3) therapy initiation leads to improved survival. This study will determine the most appropriate time to initiate ART in HIV infected individuals in Haiti. The study will enroll patients from the Haitian Study Group on Kaposi's Sarcoma and Opportunistic Infections (GHESKIO) Centers. Some participants in this study will have active pulmonary tuberculosis (TB).
This study will last at least 3 years. Participants will be randomly assigned to one of two groups at study entry. Group A participants will receive 3TC/ZDV twice daily and EFV once daily at study enrollment. Participants receiving TB therapy at the time of enrollment may be observed for 2 weeks prior to beginning early therapy. Dosage adjustment of EFV may be necessary for participants receiving rifampin as part of their TB therapy. Group B participants will receive 3TC/ZDV twice daily and EFV once daily when they develop clinical AIDS or their CD4 count drops below 200 cells/mm3 (WHO Stage IV). Directly observed therapy will be used for the first two months of treatment for every participant.
Group A participants will have 14 study visits after beginning treatment; the visits will occur at Months 1, 2, 3, and every 3 months thereafter. Medical and medication history, physical exams, and contraceptive counseling for women will occur at all visits. HIV counseling, blood collection, and HIV staging will occur at most visits. At some study visits, Group A participants will be asked to complete quality of life and adherence questionnaires. Group B participants will have 14 study visits after study entry and will begin treatment when they meet WHO criteria. Assessments will be the same as for Group A. Any participant who fails the first-line regimen during the study will switch to a second-line ART regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Efavirenz, Drug: Lamivudine/ZidovudineRandomly assigned group who will start an ART regimen of 3TC/ZDV and EFV twice daily at study entry |
| B | Active comparator | Drug: Efavirenz, Drug: Lamivudine/ZidovudineRandomly assigned group who will delay beginning ART regimen of 3TC/ZDV and EFC twice daily until they develop clinical AIDS or their CD4 count drops below 200 cells/mm3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-infected
- Received pre- and post-test counseling at the GHESKIO Centers
- CD4 count between 200 and 350 cells/mm3
- World Health Organization (WHO) Stage I, II, or III HIV disease
- Willing to use acceptable forms of contraception
Key exclusion criteria (15 listed)
- WHO Stage IV HIV disease (AIDS)
- 7 or more days of cumulative ART prior to study entry OR on ART at time of study entry
- Active TB, if diagnostic work-up for TB is incomplete OR if decision to treat TB has not been made. More information on this criterion can be found in the protocol.
- Recurrent active TB OR history of interrupted or incomplete TB therapy. More information on this criterion can be found in the protocol.
- Has not been evaluated for latent TB and decision to treat latent TB with isoniazid has not been made. More information on this criterion can be found in the protocol.
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 |
|---|---|---|
| EfavirenzAlso: EFVNon-nucleoside reverse transcriptase inhibitor dosed at 600mg taken by mouth every 24 hours at bedtime | Drug | A, B |
| Lamivudine/ZidovudineAlso: 3TC/ZDV, 3TC/AZTNucleoside reverse transcriptase inhibitor dosed at 150mg/300mg fixed dose combination taken by mouth every 12 hours | Drug | A, B |
Primary outcome
Survival
Time frame: At 36 months
9 secondary outcomes
Safety and drug-associated side effects and toxicities of the study drugs
Time frame: Throughout study
Pattern and frequency of antiretroviral drug resistance during ART
Time frame: Throughout study
Occurrence and clinical outcome of opportunistic infections, viral coinfections, and immune reconstitution syndromes observed during ART
Time frame: Throughout study
TB treatment outcomes in patients with active pulmonary TB at enrollment
Time frame: Throughout study
Quality of life scores based on self-report questionnaires
Time frame: Throughout study
Adherence based on self-report questionnaires and dosage count
Time frame: Throughout study
Cost of therapy
Time frame: Throughout study
Plasma HIV-1 RNA below limits of quantitation after initiating ART
Time frame: Every 6 months throughout study
Absolute CD4 cell count change from baseline in subjects who initiate ART
Time frame: Every 6 months throughout study
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 15 Oct 2014.
- Background: PubMed 15900634Blankson JN. Primary HIV-1 infection: to treat or not to treat? AIDS Read. 2005 May;15(5):245-6, 249-51.
- Background: PubMed 15668542Duncombe C, Kerr SJ, Ruxrungtham K, Dore GJ, Law MG, Emery S, Lange JM, Phanuphak P, Cooper DA. HIV disease progression in a patient cohort treated via a clinical research network in a resource limited setting. AIDS. 2005 Jan 28;19(2):169-78. doi: 10.1097/00002030-200501280-00009.
- Background: PubMed 15647610Pape JW. Tuberculosis and HIV in the Caribbean: approaches to diagnosis, treatment, and prophylaxis. Top HIV Med. 2004 Dec-2005 Jan;12(5):144-9.
- Background: PubMed 15786887Teck R, Ascurra O, Gomani P, Manzi M, Pasulani O, Kusamale J, Salaniponi FM, Humblet P, Nunn P, Scano F, Harries AD, Zachariah R. WHO clinical staging of HIV infection and disease, tuberculosis and eligibility for antiretroviral treatment: relationship to CD4 lymphocyte counts. Int J Tuberc Lung Dis. 2005 Mar;9(3):258-62.
- Background: PubMed 12825959Thorner A, Rosenberg E. Early versus delayed antiretroviral therapy in patients with HIV infection : a review of the current guidelines from an immunological perspective. Drugs. 2003;63(13):1325-37. doi: 10.2165/00003495-200363130-00001.
- Derived from this study: PubMed 34235862Joseph Y, Yao Z, Dua A, Severe P, Collins SE, Bang H, Antoine Jean-Juste M, Ocheretina O, Apollon A, McNairy ML, Dupnik K, Cremieux E, Byrne A, Pape JW, Koenig SP. Long-term mortality after tuberculosis treatment among persons living with HIV in Haiti. J Int AIDS Soc. 2021 Jul;24(7):e25721. doi: 10.1002/jia2.25721.
- Derived from this study: PubMed 25519790Collins SE, Jean Juste MA, Koenig SP, Secours R, Ocheretina O, Bernard D, Riviere C, Calnan M, Dunning A, Hurtado Rua SM, Johnson WD Jr, Pape JW, Fitzgerald DW, Severe P. CD4 deficit and tuberculosis risk persist with delayed antiretroviral therapy: 5-year data from CIPRA HT-001. Int J Tuberc Lung Dis. 2015 Jan;19(1):50-7. doi: 10.5588/ijtld.14.0217.
- Derived from this study: PubMed 24695352Haas DW, Severe P, Jean Juste MA, Pape JW, Fitzgerald DW. Functional CYP2B6 variants and virologic response to an efavirenz-containing regimen in Port-au-Prince, Haiti. J Antimicrob Chemother. 2014 Aug;69(8):2187-90. doi: 10.1093/jac/dku088. Epub 2014 Apr 2.
- Derived from this study: PubMed 21949643Koenig SP, Bang H, Severe P, Jean Juste MA, Ambroise A, Edwards A, Hippolyte J, Fitzgerald DW, McGreevy J, Riviere C, Marcelin S, Secours R, Johnson WD, Pape JW, Schackman BR. Cost-effectiveness of early versus standard antiretroviral therapy in HIV-infected adults in Haiti. PLoS Med. 2011 Sep;8(9):e1001095. doi: 10.1371/journal.pmed.1001095. Epub 2011 Sep 20.
- Derived from this study: PubMed 20647201Severe P, Juste MA, Ambroise A, Eliacin L, Marchand C, Apollon S, Edwards A, Bang H, Nicotera J, Godfrey C, Gulick RM, Johnson WD Jr, Pape JW, Fitzgerald DW. Early versus standard antiretroviral therapy for HIV-infected adults in Haiti. N Engl J Med. 2010 Jul 15;363(3):257-65. doi: 10.1056/NEJMoa0910370.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Jean William Pape, MD principal investigator
Cornell - GHESKIO, Institut de Laboratoire et de Recherches and Division of International Medicine and Infectious Diseases, Cornell University
Patrice Severe, MD study director
Cornell - GHESKIO, Institut de Laboratoire et de Recherches
Daniel W. Fitzgerald, MD study director
Division of International Medicine and Infectious Diseases, Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efavirenz and Lamivudine/Zidovudine in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Haiti.
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 5 inclusion and 15 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 15 Oct 2014. 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 Haiti. 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.
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 (time frame: At 36 months). 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 NCT00120510, which also lists 10 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 15 Oct 2014.