HIV InfectionsNCT00091936
Effectiveness of Directly Observed Therapy in Combined HIV and Tuberculosis Treatment in Resource-limited Settings
A study testing Didanosine, Efavirenz and Lamivudine in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in South Africa.
Trial summary
Tuberculosis (TB), a bacterial infection common in HIV infected people, is a major problem in developing countries. The purpose of this study is to test the effectiveness of a combined treatment strategy using directly observed therapy (DOT) for HIV infected patients with TB. 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?
- Didanosine, Efavirenz and Lamivudine
- How many people
- 592 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Aug 2009to not given
- 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
- TB infected
- Currently receiving standard anti-TB therapy (isoniazid, rifampicin, ethambutol, and pyrazinamide)
- Currently participating in the Prince Cyril Zulu CDC Directly Observed Therapy (DOT) program and receiving treatment daily either there or in the community with a supervised community nurse or trained health worker
- Intending to stay in the area for the duration of the study
- Willing to participate in all follow-up visits
- Willing to use acceptable forms of contraception
- Female participants must be willing to have regular pregnancy tests during ART
Who cannot join
- Have had 28 days or more of cumulative ART prior to study entry. Participants who have taken mother-to-child transmission (MTCT) and postexposure prophylaxis (PEP) prevention treatments are not excluded.
- Less than 10 days or greater than 28 days since starting current TB treatment
- Body temperature greater than 38.5 C (101.3 F)
- Rash, nausea, or vomiting of Grade 3 or higher
- Hospitalized or referred for hospitalization for care and treatment of opportunistic infections, TB, or other causes at screening or enrollment
- CD4 count less than 50 cells/microL within 28 days of study entry
Show all 16Show fewer
- TB meningitis or TB that has spread to the blood and organs other than the lungs
- History of prior TB treatment or previous active TB episode unresponsive to a standard anti-TB regimen
- History of or current AIDS-defining condition as defined by the World Health Organization (WHO)
- History of or current pancreatitis
- Peripheral neuropathy of Grade 2 or higher
- Currently taking certain medications
- Suspected multidrug resistant (MDR) TB
- Any condition that, in the opinion of the investigator, may interfere with the study
- Participation in any other study that may interfere with this study
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
King Edward VIII Hospital
KwaKhangela, Durban
Prince Cyril Zulu CDC
KwaKhangela, Durban
About this study
Official title: Implementing Anti-Retroviral Therapy in Resource-Constrained Settings: A Randomized Controlled Trial to Assess the Effect of Integrated Tuberculosis and HIV Care on the Incidence of AIDS-Defining Conditions or Mortality in Subjects Co-Infected With Tuberculosis and HIV
Tuberculosis (TB), a bacterial infection common in HIV infected people, is a major problem in developing countries. The purpose of this study is to test the effectiveness of a combined treatment strategy using directly observed therapy (DOT) for HIV infected patients with TB. Participants will be recruited from resource-poor communities in Durban, South Africa.
Read the detailed description
TB is the most common serious infectious complication associated with HIV in sub-Saharan Africa and is also the most common cause of death among HIV infected patients in developing countries. Furthermore, TB in an HIV infected person accelerates the progression of HIV disease and hastens death. This study will evaluate a combined TB and antiretroviral treatment (ART) strategy utilizing DOT in HIV infected people coinfected with TB. This study will compare two treatment strategies: TB and HIV medications given concurrently (integrated arm) and TB treatment completed first, followed by HIV treatment (sequential arm).
This study has two parts. The entire study will last 24 months after participants have been randomly assigned to one of two arms. Arm 1 (integrated arm) participants will receive didanosine (ddI), efavirenz (EFV), and lamivudine (3TC) once daily concurrent with standard TB therapy. ART and TB medications will be provided through DOT on weekdays; participants will take their medications without DOT on weekends. Arm 1 participants will also attend four 15- to 20-minute sessions of an adherence study program at study start, Week 2, Month 2, and 1 to 3 weeks prior to the end of TB therapy.
Arm 2 (sequential arm) participants will first receive DOT-provided TB treatment alone. After completion of TB treatment, participants will receive ddI, EFV, and 3TC once daily without DOT.
Study visits in the first part of the study will occur at screening, study start, Weeks 1, 2, and 3, and every month until the end of the first part of the study at Month 12. Study visits will include blood collection, medical and medication history assessment, a physical exam, and pill counts. Patients will be asked to complete an adherence questionnaire at every study visit and a sexual behavior survey and quality of life questionnaire at study start and Month 6.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Didanosine, Efavirenz, Lamivudine, Standard TB treatment
- Keywords
- Treatment Naive, Directly Observed Therapy, DOT, TB
- Medical subject headings
- HIV Infections, Tuberculosis, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DidanosineDrug
EfavirenzDrug
LamivudineDrug
Standard TB treatmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of an AIDS-defining illness
18-month mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2004 (estimated)
- Study startAug 2009
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 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
- 592 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Salim S. Abdool Karim, MBChB, PhD, Study chair, University of KwaZulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091936
- Sponsor's protocol ID
- CAPRISA START
- Other IDs
- CAPRISA 001, START, CIPRA
- Status last verified
- Jan 2007
- First submitted
- 20 Sep 2004
- Last updated
- 29 Mar 2010
- Results posted
- No
Publications
Cahn P, Perez H, Ben G, Ochoa C. Tuberculosis and HIV: a partnership against the most vulnerable. J Int Assoc Physicians AIDS Care (Chic). 2003 Jul-Sep;2(3):106-23. doi: 10.1177/154510970300200303.
PubMed 14556429Corbett EL, Watt CJ, Walker N, Maher D, Williams BG, Raviglione MC, Dye C. The growing burden of tuberculosis: global trends and interactions with the HIV epidemic. Arch Intern Med. 2003 May 12;163(9):1009-21. doi: 10.1001/archinte.163.9.1009.
PubMed 12742798de Jong BC, Israelski DM, Corbett EL, Small PM. Clinical management of tuberculosis in the context of HIV infection. Annu Rev Med. 2004;55:283-301. doi: 10.1146/annurev.med.55.091902.103753.
PubMed 14746522Girardi E, Antonucci G, Vanacore P, Palmieri F, Matteelli A, Iemoli E, Carradori S, Salassa B, Pasticci MB, Raviglione MC, Ippolito G; GISTA-SIMIT Study Group. Tuberculosis in HIV-infected persons in the context of wide availability of highly active antiretroviral therapy. Eur Respir J. 2004 Jul;24(1):11-7. doi: 10.1183/09031936.04.00109303.
PubMed 15293599Girardi E, Goletti D, Antonucci G, Ippolito G. Tuberculosis and HIV: a deadly interaction. J Biol Regul Homeost Agents. 2001 Jul-Sep;15(3):218-23.
PubMed 11693427Gengiah TN, Holford NH, Botha JH, Gray AL, Naidoo K, Abdool Karim SS. The influence of tuberculosis treatment on efavirenz clearance in patients co-infected with HIV and tuberculosis. Eur J Clin Pharmacol. 2012 May;68(5):689-95. doi: 10.1007/s00228-011-1166-5. Epub 2011 Nov 23.
PubMed 22108776
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Anti-Retroviral Therapy in Resource-Constrained Settings: A Randomized Controlled Trial to Assess the Effect of Integrated Tuberculosis and HIV Care on the Incidence of AIDS-Defining Conditions or Mortality in Subjects Co-Infected With Tuberculosis and HIV
- ClinicalTrials.gov ID
- NCT00091936
- Acronym / sponsor ID
- CAPRISA START
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- Treatment Naive, Directly Observed Therapy, DOT, TB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2009
- First posted
- 21 Sep 2004 (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.
Tuberculosis (TB), a bacterial infection common in HIV infected people, is a major problem in developing countries. The purpose of this study is to test the effectiveness of a combined treatment strategy using directly observed therapy (DOT) for HIV infected patients with TB. Participants will be recruited from resource-poor communities in Durban, South Africa.
Detailed description
TB is the most common serious infectious complication associated with HIV in sub-Saharan Africa and is also the most common cause of death among HIV infected patients in developing countries. Furthermore, TB in an HIV infected person accelerates the progression of HIV disease and hastens death. This study will evaluate a combined TB and antiretroviral treatment (ART) strategy utilizing DOT in HIV infected people coinfected with TB. This study will compare two treatment strategies: TB and HIV medications given concurrently (integrated arm) and TB treatment completed first, followed by HIV treatment (sequential arm).
This study has two parts. The entire study will last 24 months after participants have been randomly assigned to one of two arms. Arm 1 (integrated arm) participants will receive didanosine (ddI), efavirenz (EFV), and lamivudine (3TC) once daily concurrent with standard TB therapy. ART and TB medications will be provided through DOT on weekdays; participants will take their medications without DOT on weekends. Arm 1 participants will also attend four 15- to 20-minute sessions of an adherence study program at study start, Week 2, Month 2, and 1 to 3 weeks prior to the end of TB therapy.
Arm 2 (sequential arm) participants will first receive DOT-provided TB treatment alone. After completion of TB treatment, participants will receive ddI, EFV, and 3TC once daily without DOT.
Study visits in the first part of the study will occur at screening, study start, Weeks 1, 2, and 3, and every month until the end of the first part of the study at Month 12. Study visits will include blood collection, medical and medication history assessment, a physical exam, and pill counts. Patients will be asked to complete an adherence questionnaire at every study visit and a sexual behavior survey and quality of life questionnaire at study start and Month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV infected
- TB infected
- Currently receiving standard anti-TB therapy (isoniazid, rifampicin, ethambutol, and pyrazinamide)
- Currently participating in the Prince Cyril Zulu CDC Directly Observed Therapy (DOT) program and receiving treatment daily either there or in the community with a supervised community nurse or trained health worker
- Intending to stay in the area for the duration of the study
Key exclusion criteria (16 listed)
- Have had 28 days or more of cumulative ART prior to study entry. Participants who have taken mother-to-child transmission (MTCT) and postexposure prophylaxis (PEP) prevention treatments are not excluded.
- Less than 10 days or greater than 28 days since starting current TB treatment
- Body temperature greater than 38.5 C (101.3 F)
- Rash, nausea, or vomiting of Grade 3 or higher
- Hospitalized or referred for hospitalization for care and treatment of opportunistic infections, TB, or other causes at screening or enrollment
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 |
|---|---|---|
| Didanosine | Drug | – |
| Efavirenz | Drug | – |
| Lamivudine | Drug | – |
| Standard TB treatment | Drug | – |
Primary outcome
Diagnosis of an AIDS-defining illness
18-month mortality
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 29 Mar 2010.
- Background: PubMed 14556429Cahn P, Perez H, Ben G, Ochoa C. Tuberculosis and HIV: a partnership against the most vulnerable. J Int Assoc Physicians AIDS Care (Chic). 2003 Jul-Sep;2(3):106-23. doi: 10.1177/154510970300200303.
- Background: PubMed 12742798Corbett EL, Watt CJ, Walker N, Maher D, Williams BG, Raviglione MC, Dye C. The growing burden of tuberculosis: global trends and interactions with the HIV epidemic. Arch Intern Med. 2003 May 12;163(9):1009-21. doi: 10.1001/archinte.163.9.1009.
- Background: PubMed 14746522de Jong BC, Israelski DM, Corbett EL, Small PM. Clinical management of tuberculosis in the context of HIV infection. Annu Rev Med. 2004;55:283-301. doi: 10.1146/annurev.med.55.091902.103753.
- Background: PubMed 15293599Girardi E, Antonucci G, Vanacore P, Palmieri F, Matteelli A, Iemoli E, Carradori S, Salassa B, Pasticci MB, Raviglione MC, Ippolito G; GISTA-SIMIT Study Group. Tuberculosis in HIV-infected persons in the context of wide availability of highly active antiretroviral therapy. Eur Respir J. 2004 Jul;24(1):11-7. doi: 10.1183/09031936.04.00109303.
- Background: PubMed 11693427Girardi E, Goletti D, Antonucci G, Ippolito G. Tuberculosis and HIV: a deadly interaction. J Biol Regul Homeost Agents. 2001 Jul-Sep;15(3):218-23.
- Derived from this study: PubMed 22108776Gengiah TN, Holford NH, Botha JH, Gray AL, Naidoo K, Abdool Karim SS. The influence of tuberculosis treatment on efavirenz clearance in patients co-infected with HIV and tuberculosis. Eur J Clin Pharmacol. 2012 May;68(5):689-95. doi: 10.1007/s00228-011-1166-5. Epub 2011 Nov 23.
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 study chair
University of KwaZulu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Didanosine, Efavirenz and Lamivudine in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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 8 inclusion and 16 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 29 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Diagnosis of an AIDS-defining illness. 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 NCT00091936, 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 29 Mar 2010.