CompletedPhase 2/3

Investigational Vaccine for the Prevention of Disseminated Tuberculosis in HIV Infected People

Tanzania1,975 participantsStarted 2001-09

Plain-language summary

A significant number of HIV infected patients in Africa also have disseminated tuberculosis (infection throughout multiple organs). This type of tuberculosis is a significant cause of mortality in these patients. The purpose of this study is to evaluate the safety and effectiveness of a vaccine designed to prevent disseminated tuberculosis.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * HIV infection * CD4 count more than 200 cells/mm3 * BCG scar Exclusion Criteria: * Active tuberculosis. Patients will be deferred from study enrollment until they show no signs of active disease. * Serious underlying disease (e.g., congestive heart failure, advanced cancer) * Life expectancy of less than 2 years * Pregnancy. Women who are pregnant may be eligible for the study after they give birth.

What they're measuring

safety and efficacy of a prime-boost immunization strategy for the prevention of HIV-associated dTB and pTB

Timeframe: every six months

Trial details

NCT IDNCT00052195

SponsorDartmouth-Hitchcock Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-12

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