HIV InfectionsPhase 3SAPITNCT00398996
A Study to Compare Three Existing Starting Points of Anti-Retroviral Therapy (ART) Initiation in HIV/Tuberculosis (TB) Co-infected Patients
A Phase 3 study testing Early versus intermediate versus late initiation of ART in people with HIV Infections and Tuberculosis, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.
Trial summary
This is a randomized, open-label study comparing three existing treatment strategies of ART initiation in HIV/TB co-infected patients: Group 1: early initiation of ART with TB treatment, Group 2: initiation of ART upon completion of the intensive phase of TB treatment, Group 3: initiation of ART upon completion of the… 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?
- Early versus intermediate versus late initiation of ART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 642 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jun 2005to Jul 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
- HIV infected patients co-infected with TB
- Receiving any one of the standard anti-TB therapy regimens
- All patients must agree to use contraception since they will be on efavirenz.
Who cannot join
- Entry into the treatment programme is based on a clinical assessment and should patients not be clinically eligible to maintain a treatment regimen,their entry may be deferred or precluded
Trial locations and contacts
1 site in 1 country.
South Africa1 site
CAPRISA eThekwini Clinical Research Site
Durban, KwaZulu-Natal, 4001
About this study
Official title: Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients
This is a randomized, open-label study comparing three existing treatment strategies of ART initiation in HIV/TB co-infected patients:
Group 1: early initiation of ART with TB treatment, Group 2: initiation of ART upon completion of the intensive phase of TB treatment, Group 3: initiation of ART upon completion of the continuation phase of TB treatment
Approximately 700 men and women ≥ 18 years of age with documented HIV infection and smear-positive pulmonary TB patients will be enrolled. Eligible TB/HIV co-infected patients will be offered antiretroviral therapy (ART), starting at one of the three time points listed above through the CAPRISA AIDS treatment programme which includes extensive counselling and adherence support. The study participants will be followed for 18 months to assess the primary study endpoint of the optimal time to start antiretroviral therapy (ART) in patients on tuberculosis (TB) treatment by comparing clinical status (CD4+ cell count, viral load, opportunistic infections.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Early versus intermediate versus late initiation of ART
- Keywords
- antiretroviral therapy, HIV, Opportunistic infections, CD4, Viral load, TB/HIV co infection, Treatment Naive
- Medical subject headings
- HIV Infections, Tuberculosis, Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early versus intermediate versus late initiation of ARTDrug
Initiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB therapy has been completed
| Study group | Role | What they receive |
|---|---|---|
| 1 - Early integrated-therapy group | Active comparator | antiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment Receives: Drug: Early versus intermediate versus late initiation of ART |
| 2 - Late integrated-therapy group | Active comparator | antiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment Receives: Drug: Early versus intermediate versus late initiation of ART |
| 3 - Sequential-therapy group | Active comparator | Antiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment Receives: Drug: Early versus intermediate versus late initiation of ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the incidence of progression to AIDS defining illness or mortality
Measured: 18 months
Secondary outcomes (1)
A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startJun 2005
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for the AIDS Programme of Research in South Africa
- Sponsor type
- Research network
- Investigators
- Salim S Abdool karim, MBChB, PhD, Principal investigator, CAPRISA, University of KwaZulu-Natal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398996
- Sponsor's protocol ID
- CAPRISA 003
- Acronym
- SAPIT
- Status last verified
- Mar 2011
- First submitted
- 7 Nov 2006
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abdool-Karim SS, Abdool-Karim Q, Friedland G, Lalloo U, El-Sadr WM; START project. Implementing antiretroviral therapy in resource-constrained settings: opportunities and challenges in integrating HIV and tuberculosis care. AIDS. 2004 Apr 30;18(7):975-9. doi: 10.1097/00002030-200404300-00004. No abstract available.
PubMed 15096799Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray A, Gengiah T, Nair G, Bamber S, Singh A, Khan M, Pienaar J, El-Sadr W, Friedland G, Abdool Karim Q. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med. 2010 Feb 25;362(8):697-706. doi: 10.1056/NEJMoa0905848.
PubMed 20181971Naidoo K, Yende-Zuma N, Padayatchi N, Naidoo K, Jithoo N, Nair G, Bamber S, Gengiah S, El-Sadr WM, Friedland G, Abdool Karim S. The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial. Ann Intern Med. 2012 Sep 4;157(5):313-24. doi: 10.7326/0003-4819-157-5-201209040-00004.
PubMed 22944873Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray AL, Gengiah T, Gengiah S, Naidoo A, Jithoo N, Nair G, El-Sadr WM, Friedland G, Abdool Karim Q. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med. 2011 Oct 20;365(16):1492-501. doi: 10.1056/NEJMoa1014181.
PubMed 22010915
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Compare Three Existing Starting Points of ART Initiation in HIV/TB Co-infected Patients
- ClinicalTrials.gov ID
- NCT00398996
- Acronym / sponsor ID
- SAPIT / CAPRISA 003
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- antiretroviral therapy, HIV, Opportunistic infections, CD4, Viral load, TB/HIV co infection, Treatment Naive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 642 participants (actual)
- Lead sponsor
- Centre for the AIDS Programme of Research in South AfricaResearch network
- Study start
- Jun 2005
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Nov 2006 (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.
This is a randomized, open-label study comparing three existing treatment strategies of ART initiation in HIV/TB co-infected patients:
Group 1: early initiation of ART with TB treatment, Group 2: initiation of ART upon completion of the intensive phase of TB treatment, Group 3: initiation of ART upon completion of the continuation phase of TB treatment
Approximately 700 men and women ≥ 18 years of age with documented HIV infection and smear-positive pulmonary TB patients will be enrolled. Eligible TB/HIV co-infected patients will be offered antiretroviral therapy (ART), starting at one of the three time points listed above through the CAPRISA AIDS treatment programme which includes extensive counselling and adherence support. The study participants will be followed for 18 months to assess the primary study endpoint of the optimal time to start antiretroviral therapy (ART) in patients on tuberculosis (TB) treatment by comparing clinical status (CD4+ cell count, viral load, opportunistic infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 - Early integrated-therapy group | Active comparator | Drug: Early versus intermediate versus late initiation of ARTantiretroviral therapy to be initiated within 4 weeks of starting tuberculosis treatment |
| 2 - Late integrated-therapy group | Active comparator | Drug: Early versus intermediate versus late initiation of ARTantiretroviral therapy to be initiated within 4 weeks of completing the intensive phase of tuberculosis treatment |
| 3 - Sequential-therapy group | Active comparator | Drug: Early versus intermediate versus late initiation of ARTAntiretroviral therapy to be initiated within 4 weeks after completing tuberculosis treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV infected patients co-infected with TB
- Receiving any one of the standard anti-TB therapy regimens
- All patients must agree to use contraception since they will be on efavirenz.
Key exclusion criteria (1 listed)
- Entry into the treatment programme is based on a clinical assessment and should patients not be clinically eligible to maintain a treatment regimen,their entry may be deferred or precluded
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 versus intermediate versus late initiation of ARTInitiation of once daily ddI (400 / 250mg), 3TC (300mg) and EFV (600mg)during the intensive phase of TB therapy or during the continuation phase of TB therapy or once TB therapy has been completed | Drug | 1 - Early integrated-therapy group, 2 - Late integrated-therapy group, 3 - Sequential-therapy group |
Primary outcome
To measure the incidence of progression to AIDS defining illness or mortality
Time frame: 18 months
1 secondary outcome
A comparison of CD4+ cell count, viral load, opportunistic infections across the 3 study arms
Time frame: 18 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 24 Mar 2011.
- Background: PubMed 15096799Abdool-Karim SS, Abdool-Karim Q, Friedland G, Lalloo U, El-Sadr WM; START project. Implementing antiretroviral therapy in resource-constrained settings: opportunities and challenges in integrating HIV and tuberculosis care. AIDS. 2004 Apr 30;18(7):975-9. doi: 10.1097/00002030-200404300-00004. No abstract available.
- Results publication: PubMed 20181971Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray A, Gengiah T, Nair G, Bamber S, Singh A, Khan M, Pienaar J, El-Sadr W, Friedland G, Abdool Karim Q. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med. 2010 Feb 25;362(8):697-706. doi: 10.1056/NEJMoa0905848.
- Derived from this study: PubMed 22944873Naidoo K, Yende-Zuma N, Padayatchi N, Naidoo K, Jithoo N, Nair G, Bamber S, Gengiah S, El-Sadr WM, Friedland G, Abdool Karim S. The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial. Ann Intern Med. 2012 Sep 4;157(5):313-24. doi: 10.7326/0003-4819-157-5-201209040-00004.
- Derived from this study: PubMed 22010915Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray AL, Gengiah T, Gengiah S, Naidoo A, Jithoo N, Nair G, El-Sadr WM, Friedland G, Abdool Karim Q. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med. 2011 Oct 20;365(16):1492-501. doi: 10.1056/NEJMoa1014181.
- Centre for the AIDS Programme of Research in South Africa's websiteLink provided by the sponsor.
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.
Salim S Abdool karim, MBChB, PhD principal investigator
CAPRISA, University of KwaZulu-Natal
1 site 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 versus intermediate versus late initiation of ART in people with HIV Infections and Tuberculosis, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.
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 3 inclusion and 1 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 24 Mar 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 South Africa. 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?
To measure the incidence of progression to AIDS defining illness or mortality (time frame: 18 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 NCT00398996, which also lists 4 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 24 Mar 2011.