[Randomized clinical trial investigating three chemoprophylaxis regimens for latent tuberculosis infection in HIV-infected patients].

Abstract

OBJECTIVE:

To evaluate the adherence to, and safety of three chemoprophylaxis regimens for latent tuberculosis (TB) infection in HIV-infected patients with a positive tuberculin skin test.

PATIENTS AND METHODS:

A randomized, comparative, open clinical assay was carried out in 316 HIV-infected patients in 12 Spanish hospitals. Patients were randomly assigned to one of three regimens, 108 to isoniazid for six months (6H), 103 to rifampin and isoniazid for three months (3RH), and 105 to rifampin and pyrazinamide for two months (2RZ). After completion of treatment, patients were followed-up for two years.

RESULTS:

The period of observation following completion of treatment was 115, 108 and 101 person-years for 6H, 3RH and 2RZ, respectively. Twenty-seven percent of patients voluntarily abandoned chemoprophylaxis and 9.7% were withdrawn due to adverse side-effects or interactions. Seven patients were withdrawn due to hepatotoxicity (5 in 6H, 2 in 3RH and 0 in 2RZ). No appreciable differences were found among the three regimens. There were 11 cases of tuberculosis during follow-up. The TB rates (cases per 100 person-years) in the three treatment groups were 3.48 in 6H, 4.63 in 3RH and 1.98 in 2RZ. With respect to 2RZ, the relative risk for TB in the 6H and 3RH regimens was 1.76 and 2.34, respectively.

CONCLUSIONS:

The safety of the 2RZ regimen for prophylaxis of latent TB infection in HIV patients was similar to that of the 6H and 3RH regimens. The incidence of hepatotoxicity was not higher in patients who received 2RZ.

• Authors: Antonio Rivero, Luis López-Cortés, Rafael Castillo, José Verdejo, Miguel Angel García, Francisco Javier Martínez-Marcos, Felipe Díez, José Carlos Escribano, Jesús Canueto, Fernando Lozano, Juan Pasquau, Juan José Hernández, Manuel Márquez, José María Kindelán, Grupo Andaluz para el estudio de las Enfermedades Infecciosas (GAEI)
• Journal: Enfermedades infecciosas y microbiologia clinica (Enferm Infecc Microbiol Clin) Vol. 25 Issue 5 Pg. 305-10 (May 2007) ISSN: 0213-005X [Print] Spain
• Vernacular Title: Ensayo clínico aleatorizado para evaluar tres pautas cortas de tratamiento de la infección latente tuberculosa en pacientes infectados por el VIH.
• PMID: 17504683 (Publication Type: Comparative Study, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antitubercular Agents
• Pyrazinamide
• Isoniazid
• Rifampin

Topics

• Adult
• Antitubercular Agents (therapeutic use)
• Drug Therapy, Combination
• Female
• HIV Infections (complications)
• Humans
• Isoniazid (therapeutic use)
• Male
• Mycobacterium tuberculosis (physiology)
• Pyrazinamide (therapeutic use)
• Rifampin (therapeutic use)
• Tuberculosis (complications, prevention & control)
• Virus Latency