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

Purpose

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	Intervention
HIV Infection	Other: Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Dapsone Itraconazole Fluconazole

U.S. FDA Resources

Further study details as provided by Chiang Mai University:

Primary Outcome Measures:

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.


Enrollment:	74
Study Start Date:	June 2009
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Criteria

Inclusion Criteria:

Age ≥ 18 years old
regularly receiving highly active antiretroviral therapy (HAART) during follow up
CD4 cell count < 200 cells/mm3
HIV-1 RNA < 50 copies/ml after receiving HAART
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
given written informed consent

Exclusion Criteria:

1) pregnancy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392430

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

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
Study First Received:	July 11, 2011
Last Updated:	May 16, 2012
Health Authority:	Thailand: Ethical Committee

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

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

ClinicalTrials.gov processed this record on September 23, 2016