Discontinuation of Primary and Secondary Prophylaxis for Opportunistic Infections in HIV-infected Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01392430 |
Recruitment Status
:
Completed
First Posted
: July 12, 2011
Last Update Posted
: May 17, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Other: Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin | Not Applicable |
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 |

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
|
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01392430
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 |
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 |
First Posted: | July 12, 2011 Key Record Dates |
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 |