Effectiveness of Directly Observed Therapy in Combined HIV and Tuberculosis Treatment in Resource-limited Settings

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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. Participants will be recruited from resource-poor communities in Durban, South Africa.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Didanosine; Efavirenz; Lamivudine

Criteria

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