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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
HIV Infection	Other: Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	74 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	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
Study Start Date :	June 2009
Actual Primary Completion Date :	January 2012
Actual Study Completion Date :	January 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
No Intervention: Arm A; Continuation of prophylaxis of opportunistic infections
Experimental: Arm B; Discontinuation of opportunistic infections	Other: Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin; Discontinuation of prophylaxis for opportunistic infections

Outcome Measures

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Primary Outcome Measures :

1. Incidence of opportunistic infections [ Time Frame: Participants will be followed up to 135 weeks ]

   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Thailand
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Muang, Chiang Mai, Thailand, 50130

Sponsors and Collaborators

Chiang Mai University

Investigators

Principal Investigator:	Romanee Chaiwarith, MD, MHS.	Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Romanee Chaiwarith, Faculty of Medicine, Chiang Mai University
ClinicalTrials.gov Identifier:	NCT01392430 History of Changes
Other Study ID Numbers:	OI prophylaxis
First Posted:	July 12, 2011
Last Update Posted:	May 17, 2012
Last Verified:	May 2012

Keywords provided by Chiang Mai University:

Primary prophylaxis; Secondary prophylaxis; Discontinuation

Additional relevant MeSH terms:

HIV Infections; Infection; Communicable Diseases; Opportunistic Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Parasitic Diseases; Itraconazole; Hydroxyitraconazole

Fluconazole; Dapsone; Trimethoprim, Sulfamethoxazole Drug Combination; Antifungal Agents; Anti-Infective Agents; 14-alpha Demethylase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Steroid Synthesis Inhibitors; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors