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
  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:


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
Genders Eligible for Study:   Both
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
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

No publications provided by Chiang Mai University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Acquired Immunodeficiency Syndrome
Opportunistic Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Parasitic Diseases
Fluconazole
Itraconazole
Hydroxyitraconazole
Trimethoprim-Sulfamethoxazole Combination
Azithromycin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents

ClinicalTrials.gov processed this record on August 18, 2014