Discontinuation of Primary and Secondary Prophylaxis for Opportunistic Infections in HIV-infected Patients

This study has been completed.
Sponsor:
Information provided by:
Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01392430
First received: July 11, 2011
Last updated: May 16, 2012
Last verified: May 2012

July 11, 2011
May 16, 2012
June 2009
January 2012   (final data collection date for primary outcome measure)
Incidence of opportunistic infections [ Time Frame: Participants will be followed up to 135 weeks ] [ Designated as safety issue: No ]

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.
Incidence of opportunistic infections [ Time Frame: Participants will be followed for an average of 12 months ] [ Designated as safety issue: No ]

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.
Complete list of historical versions of study NCT01392430 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Discontinuation of Primary and Secondary Prophylaxis for Opportunistic Infections in HIV-infected Patients
Discontinuation of Primary and Secondary Prophylaxis for Opportunistic Infections in HIV-infected Patients Who Had CD4+ Cell Count <200 Cells/mm3 But Undetectable Plasma HIV-1 RNA

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
HIV Infection
Other: Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin
Discontinuation of prophylaxis for opportunistic infections
  • No Intervention: Arm A
    Continuation of prophylaxis of opportunistic infections
  • Experimental: Arm B
    Discontinuation of opportunistic infections
    Intervention: Other: Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin
Chaiwarith R, Praparattanapan J, Nuntachit N, Kotarathitithum W, Supparatpinyo K. Discontinuation of primary and secondary prophylaxis for opportunistic infections in HIV-infected patients who had CD4+ cell count <200 cells/mm(3) but undetectable plasma HIV-1 RNA: an open-label randomized controlled trial. AIDS Patient Care STDS. 2013 Feb;27(2):71-6. doi: 10.1089/apc.2012.0303.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. regularly receiving highly active antiretroviral therapy (HAART) during follow up
  3. CD4 cell count < 200 cells/mm3
  4. HIV-1 RNA < 50 copies/ml after receiving HAART
  5. receiving primary or secondary prophylaxis for opportunistic infections including infections caused by Pneumocystis jiroveci, Cryptococcus neoformans, Penicilliosis marneffei, Histoplasma capsulatum, Toxoplasma gondii, Mycobacterium avium complex
  6. given written informed consent

Exclusion Criteria:

1) pregnancy

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01392430
OI prophylaxis
No
Romanee Chaiwarith, Faculty of Medicine, Chiang Mai University
Chiang Mai University
Not Provided
Principal Investigator: Romanee Chaiwarith, MD, MHS. Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Chiang Mai University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP