An interventional study of Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin in HIV Infection, sponsored by Chiang Mai University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-17.
Sponsored by Chiang Mai University · Not applicable, Interventional, and Prevention
The purpose of this study is to compare the incidence of opportunistic infections between HIV-infected patients who continue and discontinue primary or secondary prophylaxis for opportunistic infections in whom receiving combination antiretroviral therapy and achieve undetectable HIV-1 RNA, but CD4 cell counts are less than 200 cells/mm3.
Currently, combination antiretroviral therapy (cART) has become the standard of care in the treatment of HIV infection in many parts of the world including Thailand. The benefits of cART represented by an increment of CD4 cell count and a suppression of HIV viral load have been reported worldwide. The National Institute of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the HIV Medicine Association of the Infectious Diseases Society of America (HIVMA/IDSA) recommended discontinuing primary and secondary prophylaxis for prevention of opportunistic infections (OIs) in HIV-infected adults and adolescents receiving cART, when the CD4 cell count increase to a certain level for a certain period of time. For instances, Pneumocystis jiroveci pneumonia (PCP) prophylaxis can be discontinued when patients receiving HAART and CD4 ≥ 200 cells/mm3 for at least 3 months (for primary prophylaxis) or at least 6 months (for secondary prophylaxis), prophylaxis for Cryptococcal meningitis, disseminated penicilliosis, cerebral toxoplasmosis, and disseminated mycobacterium avium complex can be discontinued when patients receiving HAART and CD4 ≥ 100 cells/mm3 for at least 6 months. Our practices follow this guideline. However, recently there are new data showing that there were no cases developed PCP after primary or secondary prophylaxis discontinuation even if CD4 cell count \< 200 cells/mm3. Discontinuation of secondary prophylaxis resulted in reduction in pill burdens that may improve HAART adherence, decrease drug-drug interactions, and also prevent drug adverse events that may happen.
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This study's enrollment of 74 is below the median of 120 across 4,199 interventional studies indexed under Infections.
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Exclusion Criteria:
Continuation of prophylaxis of opportunistic infections
Discontinuation of opportunistic infections
Other: Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin
Discontinuation of prophylaxis for opportunistic infections
Incidence of opportunistic infections
To test whether the incidence of opportunistic infections differs between these 2 groups * Patients receiving cART and discontinue primary or secondary prophylaxis if their HIV-1 RNA achieve undetectable level. * Patients receiving cART and continue primary or secondary prophylaxis even if HIV-1 RNA achieve undetectable level.
Time frame: Participants will be followed up to 135 weeks
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Chiang Mai University