HIV InfectionNCT01392430
Discontinuation of Primary and Secondary Prophylaxis for Opportunistic Infections in HIV-infected Patients
A study testing Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin in people with HIV Infection, run by Chiang Mai University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1) pregnancy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Muang, Chiang Mai, 50130
About this study
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
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.
Read the 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.
- Conditions
- HIV Infection
- Being tested
- Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin
- Keywords
- Primary prophylaxis, Secondary prophylaxis, Discontinuation
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycinOther
Discontinuation of prophylaxis for opportunistic infections
| Study group | Role | What they receive |
|---|---|---|
| Arm A | No intervention | Continuation of prophylaxis of opportunistic infections |
| Arm B | Experimental | Discontinuation of opportunistic infections Receives: Other: Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of opportunistic infections
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.
Measured: Participants will be followed up to 135 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJun 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Investigators
- Romanee Chaiwarith, MD, MHS., Principal investigator, Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392430
- Sponsor's protocol ID
- OI prophylaxis
- Status last verified
- May 2012
- First submitted
- 11 Jul 2011
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23373662
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01392430
- Acronym / sponsor ID
- OI prophylaxis
- Conditions
- HIV Infection
- Keywords
- Primary prophylaxis, Secondary prophylaxis, Discontinuation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | No intervention | –Continuation of prophylaxis of opportunistic infections |
| Arm B | Experimental | Other: Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycinDiscontinuation of opportunistic infections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 1) pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycinDiscontinuation of prophylaxis for opportunistic infections | Other | Arm B |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
- Derived from this study: PubMed 23373662Chaiwarith 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.
Related trials for HIV Infection
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romanee Chaiwarith, MD, MHS. principal investigator
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin in people with HIV Infection, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of opportunistic infections (time frame: Participants will be followed up to 135 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01392430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2012.