Discontinuation of Primary and Secondary Prophylaxis for Opportunistic Infections in HIV-infected Patients
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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 |
- 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 |
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| Thailand | |
| Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University | |
| Muang, Chiang Mai, Thailand, 50130 | |
| Principal Investigator: | Romanee Chaiwarith, MD, MHS. | Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University |
More Information
No publications provided
| 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 May 23, 2013