Status:
COMPLETED
Effectiveness of Directly Observed Therapy in Combined HIV and Tuberculosis Treatment in Resource-limited Settings
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 strat...
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. Furtherm...
Eligibility Criteria
Inclusion
- Inclusion Criteria for First Part of Study:
- 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
- Exclusion Criteria for First Part of Study:
- 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
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
592 Patients enrolled
Trial Details
Trial ID
NCT00091936
Start Date
August 1 2009
Last Update
March 29 2010
Active Locations (2)
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1
King Edward VIII Hospital
KwaKhangela, Durban, South Africa
2
Prince Cyril Zulu CDC
KwaKhangela, Durban, South Africa