Cryptococcal AntigenemiaPhase 3NCT07743593
Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
A Phase 3 study testing Immediate ART Initiation, Delayed ART Initiation and 10-Week Fluconazole in people with Cryptococcal Antigenemia and HIV-1-infection, run by University of Minnesota at 1 site in Uganda.
Trial summary
This randomized clinical trial will evaluate the optimal duration of fluconazole therapy and timing of antiretroviral therapy initiation among HIV-infected persons with asymptomatic cryptococcal antigenemia and low cryptococcal antigen titers in Uganda. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptococcal Antigenemia, HIV-1-infection, Cryptococcal Infection
- What is being tested?
- Immediate ART Initiation, Delayed ART Initiation and 10-Week Fluconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 1 siteUganda
- Study dates
- 5 Jan 2027to 30 Aug 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- HIV-1 infection
- Age greater than 18 years
- Ability and willingness to give informed consent
- Plasma or serum cryptococcal antigen positive with titer less than 1:160
Who cannot join
- Cannot or unlikely to attend regular clinic visits
- History of cryptococcal infection
- Symptomatic meningitis confirmed by cerebrospinal fluid cryptococcal antigen positivity
- More than 10 weeks of fluconazole therapy
- Pregnancy confirmed by urinary or serum pregnancy test
- Current breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site
Infectious Diseases Institute, Makerere University
Kampala
Radha Rajasingham, MD, 612-625-4680, radha@umn.edu
Radha Rajasingham, MD
About this study
This randomized clinical trial will evaluate the optimal duration of fluconazole therapy and timing of antiretroviral therapy initiation among HIV-infected persons with asymptomatic cryptococcal antigenemia and low cryptococcal antigen titers in Uganda.
Participants with low-titer cryptococcal antigenemia will be followed to assess whether a shorter 10-week course of fluconazole is non-inferior to the standard 24-week fluconazole regimen for 24-week cryptococcal meningitis-free survival. Among participants eligible for antiretroviral therapy timing randomization, the study will also compare immediate antiretroviral therapy initiation with delayed initiation after 14 days to evaluate 10-week hospitalization-free survival.
Participants will be followed for up to 24 weeks, with study visits and contacts to assess survival, cryptococcal meningitis, hospitalizations, adverse events, and fluconazole adherence.
Read the detailed description
Cryptococcal antigenemia can be detected in the blood before the development of symptomatic cryptococcal meningitis and is associated with increased risk of meningitis and death among persons with advanced HIV disease. Current guidelines recommend cryptococcal antigen screening and preemptive fluconazole therapy for persons with asymptomatic cryptococcal antigenemia, but the optimal duration of fluconazole therapy and the optimal timing of antiretroviral therapy initiation remain uncertain.
This randomized clinical trial will enroll HIV-infected persons with asymptomatic cryptococcal antigenemia and low cryptococcal antigen titers in Uganda. The study is designed to answer two main questions. First, it will evaluate whether a shorter 10-week course of fluconazole is non-inferior to the standard 24-week fluconazole regimen for 24-week cryptococcal meningitis-free survival. Second, among participants eligible for antiretroviral therapy timing randomization, it will evaluate whether immediate antiretroviral therapy initiation is non-inferior to delayed initiation after 14 days for 10-week hospitalization-free survival.
At enrollment, eligible participants who meet criteria for antiretroviral therapy timing randomization will be randomized to immediate antiretroviral therapy initiation or delayed antiretroviral therapy initiation after 14 days. All participants will receive fluconazole 800 mg daily beginning at enrollment and continuing for 14 days, followed by fluconazole 400 mg daily through week 10. At week 10, participants who are alive and have not developed cryptococcal meningitis will be randomized to stop fluconazole or to continue fluconazole 200 mg daily for an additional 14 weeks, for a total fluconazole duration of 24 weeks.
Participants will be followed at weeks 2, 4, 6, 8, 10, 16, 20, and 24. Study assessments will include interval history, vital status, assessment for signs and symptoms of cryptococcal meningitis, medication review and adherence assessment, physical examination or symptom-directed examination as appropriate, and adverse event monitoring. Participants who miss visits or cannot attend scheduled clinic visits may be contacted by phone or through home visits to assess vital status and meningitis events.
The primary fluconazole-duration endpoint is 24-week cryptococcal meningitis-free survival with retention in care. The primary antiretroviral therapy timing endpoint is 10-week hospitalization-free survival with retention in care. Secondary endpoints include survival, incidence of cryptococcal meningitis, grade 3 to 5 clinical adverse events or serious adverse events, hospitalization, death, and fluconazole adherence.
- Conditions
- Cryptococcal Antigenemia, HIV-1-infection, Cryptococcal Infection, Cryptococcal Meningitis
- Being tested
- Immediate ART Initiation, Delayed ART Initiation, 10-Week Fluconazole, 24-Week Fluconazole
- Keywords
- Cryptococcal antigen, CrAg, Fluconazole, Fluconazole Short-course fluconazole, Low CrAg titer, Immediate ART, Advanced HIV disease, Cryptococcal meningitis-free survival, Hospitalization-free survival, Uganda, ART initiation, Antiretroviral therapy
- Medical subject headings
- Meningitis, Cryptococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate ART InitiationDrug
Antiretroviral therapy will be initiated immediately at enrollment for participants randomized to immediate ART initiation. ART drug choice will be per clinical standard of care.
Delayed ART InitiationDrug
Antiretroviral therapy will be initiated 14 days after enrollment for participants randomized to delayed ART initiation. ART drug choice will be per clinical standard of care.
10-Week FluconazoleDrug
Participants will receive fluconazole 800 mg daily for 14 days, followed by fluconazole 400 mg daily through week 10, then stop fluconazole.
24-Week FluconazoleDrug
Participants will receive fluconazole 800 mg daily for 14 days, followed by fluconazole 400 mg daily through week 10, then fluconazole 200 mg daily for an additional 14 weeks, for a total fluconazole duration of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Immediate ART + 10-Week Fluconazole Arm Type: | Experimental | Participants eligible for ART timing randomization will initiate antiretroviral therapy immediately at enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will stop fluconazole after completing 10 weeks of preemptive fluconazole therapy. Receives: Drug: Immediate ART Initiation; Drug: 10-Week Fluconazole |
| Immediate ART + 24-Week Fluconazole | Experimental | Participants eligible for ART timing randomization will initiate antiretroviral therapy immediately at enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will continue fluconazole through 24 weeks of preemptive fluconazole therapy. Receives: Drug: Immediate ART Initiation; Drug: 24-Week Fluconazole |
| Delayed ART + 10-Week Fluconazole | Experimental | Participants eligible for ART timing randomization will delay antiretroviral therapy initiation until 14 days after enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will stop fluconazole after completing 10 weeks of preemptive fluconazole therapy. Receives: Drug: Delayed ART Initiation; Drug: 10-Week Fluconazole |
| Delayed ART + 24-Week Fluconazole | Active comparator | Participants eligible for ART timing randomization will delay antiretroviral therapy initiation until 14 days after enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will continue fluconazole through 24 weeks of preemptive fluconazole therapy. Receives: Drug: Delayed ART Initiation; Drug: 24-Week Fluconazole |
| ART-Experienced + 10-Week Fluconazole | Experimental | Participants who are already receiving ART or are not eligible for ART timing randomization will continue ART per standard clinical care. Participants who are alive and have not developed cryptococcal meningitis at week 10 will stop fluconazole after completing 10 weeks of preemptive fluconazole therapy. Receives: Drug: 10-Week Fluconazole |
| ART-Experienced + 24-Week Fluconazole | Active comparator | Participants who are already receiving ART or are not eligible for ART timing randomization will continue ART per standard clinical care. Participants who are alive and have not developed cryptococcal meningitis at week 10 will continue fluconazole through 24 weeks of preemptive fluconazole therapy. Receives: Drug: 24-Week Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-week cryptococcal meningitis-free survival with retention in care
Cryptococcal meningitis-free survival with retention in care at 24 weeks will be compared between participants randomized to 10 weeks of fluconazole and participants randomized to 24 weeks of fluconazole. Participants who develop cryptococcal meningitis, die, or are not retained in care will be considered treatment failures.
Measured: 24 weeks
10-week hospitalization-free survival with retention in care
Hospitalization-free survival with retention in care at 10 weeks will be compared between participants randomized to immediate antiretroviral therapy initiation and participants randomized to delayed antiretroviral therapy initiation. Hospitalization-free survival will include assessment of events such as meningitis, serious opportunistic infections, immune reconstitution inflammatory syndrome events, hospitalization, death, and retention in care.
Measured: 10 weeks
Secondary outcomes (6)
Incidence of grade 3 to 5 clinical adverse events or serious adverse events
Incidence of grade 3 to 5 clinical adverse events or serious adverse events will be assessed among enrolled participants.
Measured: Up to 24 weeks
24-week known survival
Known survival at 24 weeks will be assessed. Death and loss to follow-up will be considered therapeutic failures.
Measured: 24 weeks
Incidence of cryptococcal meningitis
Incidence of cryptococcal meningitis will be assessed during study follow-up.
Measured: Up to 24 weeks
Incidence of hospitalization
Incidence of hospitalization, irrespective of cause, will be assessed during study follow-up.
Measured: Up to 24 weeks
Incidence of death
Incidence of death, irrespective of cause, will be assessed during study follow-up.
Measured: Up to 24 weeks
Fluconazole adherence
Fluconazole adherence will be assessed using self-reported compliance, pharmacy records, and tablet counts when available.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start5 Jan 2027 (estimated)
- Primary completion30 Aug 2031 (estimated)
- Study completion30 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptococcal AntigenemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants with low-titer cryptococcal antigenemia will undergo sequential randomization. Participants eligible for antiretroviral therapy timing randomization will be randomized at enrollment to immediate antiretroviral therapy initiation or delayed antiretroviral therapy initiation after 14 days. At week 10, participants who are alive and have not developed cryptococcal meningitis will be randomized to stop fluconazole after 10 weeks or continue fluconazole through 24 weeks.
- Masking
- None (open label)
- Enrolment
- 505 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Radha Rajasingham, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743593
- Sponsor's protocol ID
- STUDY00024821
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
- ClinicalTrials.gov ID
- NCT07743593
- Acronym / sponsor ID
- STUDY00024821
- Conditions
- Cryptococcal Antigenemia, HIV-1-infection, Cryptococcal Infection, Cryptococcal Meningitis
- Keywords
- Cryptococcal antigen, CrAg, Fluconazole, Fluconazole Short-course fluconazole, Low CrAg titer, Immediate ART, Advanced HIV disease, Cryptococcal meningitis-free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 505 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 5 Jan 2027 (estimated)
- Primary completion
- 30 Aug 2031 (estimated)
- Study completion
- 30 Aug 2031 (estimated)
- First posted
- 4 Aug 2026 (actual)
- 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.
This randomized clinical trial will evaluate the optimal duration of fluconazole therapy and timing of antiretroviral therapy initiation among HIV-infected persons with asymptomatic cryptococcal antigenemia and low cryptococcal antigen titers in Uganda.
Participants with low-titer cryptococcal antigenemia will be followed to assess whether a shorter 10-week course of fluconazole is non-inferior to the standard 24-week fluconazole regimen for 24-week cryptococcal meningitis-free survival. Among participants eligible for antiretroviral therapy timing randomization, the study will also compare immediate antiretroviral therapy initiation with delayed initiation after 14 days to evaluate 10-week hospitalization-free survival.
Participants will be followed for up to 24 weeks, with study visits and contacts to assess survival, cryptococcal meningitis, hospitalizations, adverse events, and fluconazole adherence.
Detailed description
Cryptococcal antigenemia can be detected in the blood before the development of symptomatic cryptococcal meningitis and is associated with increased risk of meningitis and death among persons with advanced HIV disease. Current guidelines recommend cryptococcal antigen screening and preemptive fluconazole therapy for persons with asymptomatic cryptococcal antigenemia, but the optimal duration of fluconazole therapy and the optimal timing of antiretroviral therapy initiation remain uncertain.
This randomized clinical trial will enroll HIV-infected persons with asymptomatic cryptococcal antigenemia and low cryptococcal antigen titers in Uganda. The study is designed to answer two main questions. First, it will evaluate whether a shorter 10-week course of fluconazole is non-inferior to the standard 24-week fluconazole regimen for 24-week cryptococcal meningitis-free survival. Second, among participants eligible for antiretroviral therapy timing randomization, it will evaluate whether immediate antiretroviral therapy initiation is non-inferior to delayed initiation after 14 days for 10-week hospitalization-free survival.
At enrollment, eligible participants who meet criteria for antiretroviral therapy timing randomization will be randomized to immediate antiretroviral therapy initiation or delayed antiretroviral therapy initiation after 14 days. All participants will receive fluconazole 800 mg daily beginning at enrollment and continuing for 14 days, followed by fluconazole 400 mg daily through week 10. At week 10, participants who are alive and have not developed cryptococcal meningitis will be randomized to stop fluconazole or to continue fluconazole 200 mg daily for an additional 14 weeks, for a total fluconazole duration of 24 weeks.
Participants will be followed at weeks 2, 4, 6, 8, 10, 16, 20, and 24. Study assessments will include interval history, vital status, assessment for signs and symptoms of cryptococcal meningitis, medication review and adherence assessment, physical examination or symptom-directed examination as appropriate, and adverse event monitoring. Participants who miss visits or cannot attend scheduled clinic visits may be contacted by phone or through home visits to assess vital status and meningitis events.
The primary fluconazole-duration endpoint is 24-week cryptococcal meningitis-free survival with retention in care. The primary antiretroviral therapy timing endpoint is 10-week hospitalization-free survival with retention in care. Secondary endpoints include survival, incidence of cryptococcal meningitis, grade 3 to 5 clinical adverse events or serious adverse events, hospitalization, death, and fluconazole adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Participants with low-titer cryptococcal antigenemia will undergo sequential randomization. Participants eligible for antiretroviral therapy timing randomization will be randomized at enrollment to immediate antiretroviral therapy initiation or delayed antiretroviral therapy initiation after 14 days. At week 10, participants who are alive and have not developed cryptococcal meningitis will be randomized to stop fluconazole after 10 weeks or continue fluconazole through 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Immediate ART + 10-Week Fluconazole Arm Type: | Experimental | Drug: Immediate ART Initiation, Drug: 10-Week FluconazoleParticipants eligible for ART timing randomization will initiate antiretroviral therapy immediately at enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will stop fluconazole after completing 10 weeks of preemptive fluconazole therapy. |
| Immediate ART + 24-Week Fluconazole | Experimental | Drug: Immediate ART Initiation, Drug: 24-Week FluconazoleParticipants eligible for ART timing randomization will initiate antiretroviral therapy immediately at enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will continue fluconazole through 24 weeks of preemptive fluconazole therapy. |
| Delayed ART + 10-Week Fluconazole | Experimental | Drug: Delayed ART Initiation, Drug: 10-Week FluconazoleParticipants eligible for ART timing randomization will delay antiretroviral therapy initiation until 14 days after enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will stop fluconazole after completing 10 weeks of preemptive fluconazole therapy. |
| Delayed ART + 24-Week Fluconazole | Active comparator | Drug: Delayed ART Initiation, Drug: 24-Week FluconazoleParticipants eligible for ART timing randomization will delay antiretroviral therapy initiation until 14 days after enrollment. Participants who are alive and have not developed cryptococcal meningitis at week 10 will continue fluconazole through 24 weeks of preemptive fluconazole therapy. |
| ART-Experienced + 10-Week Fluconazole | Experimental | Drug: 10-Week FluconazoleParticipants who are already receiving ART or are not eligible for ART timing randomization will continue ART per standard clinical care. Participants who are alive and have not developed cryptococcal meningitis at week 10 will stop fluconazole after completing 10 weeks of preemptive fluconazole therapy. |
| ART-Experienced + 24-Week Fluconazole | Active comparator | Drug: 24-Week FluconazoleParticipants who are already receiving ART or are not eligible for ART timing randomization will continue ART per standard clinical care. Participants who are alive and have not developed cryptococcal meningitis at week 10 will continue fluconazole through 24 weeks of preemptive fluconazole therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-1 infection
- Age greater than 18 years
- Ability and willingness to give informed consent
- Plasma or serum cryptococcal antigen positive with titer less than 1:160
Key exclusion criteria (6 listed)
- Cannot or unlikely to attend regular clinic visits
- History of cryptococcal infection
- Symptomatic meningitis confirmed by cerebrospinal fluid cryptococcal antigen positivity
- More than 10 weeks of fluconazole therapy
- Pregnancy confirmed by urinary or serum pregnancy test
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 |
|---|---|---|
| Immediate ART InitiationAntiretroviral therapy will be initiated immediately at enrollment for participants randomized to immediate ART initiation. ART drug choice will be per clinical standard of care. | Drug | Immediate ART + 10-Week Fluconazole Arm Type:, Immediate ART + 24-Week Fluconazole |
| Delayed ART InitiationAntiretroviral therapy will be initiated 14 days after enrollment for participants randomized to delayed ART initiation. ART drug choice will be per clinical standard of care. | Drug | Delayed ART + 10-Week Fluconazole, Delayed ART + 24-Week Fluconazole |
| 10-Week FluconazoleParticipants will receive fluconazole 800 mg daily for 14 days, followed by fluconazole 400 mg daily through week 10, then stop fluconazole. | Drug | ART-Experienced + 10-Week Fluconazole, Delayed ART + 10-Week Fluconazole, Immediate ART + 10-Week Fluconazole Arm Type: |
| 24-Week FluconazoleParticipants will receive fluconazole 800 mg daily for 14 days, followed by fluconazole 400 mg daily through week 10, then fluconazole 200 mg daily for an additional 14 weeks, for a total fluconazole duration of 24 weeks. | Drug | ART-Experienced + 24-Week Fluconazole, Delayed ART + 24-Week Fluconazole, Immediate ART + 24-Week Fluconazole |
Primary outcome
24-week cryptococcal meningitis-free survival with retention in care
Time frame: 24 weeks
Cryptococcal meningitis-free survival with retention in care at 24 weeks will be compared between participants randomized to 10 weeks of fluconazole and participants randomized to 24 weeks of fluconazole. Participants who develop cryptococcal meningitis, die, or are not retained in care will be considered treatment failures.
10-week hospitalization-free survival with retention in care
Time frame: 10 weeks
Hospitalization-free survival with retention in care at 10 weeks will be compared between participants randomized to immediate antiretroviral therapy initiation and participants randomized to delayed antiretroviral therapy initiation. Hospitalization-free survival will include assessment of events such as meningitis, serious opportunistic infections, immune reconstitution inflammatory syndrome events, hospitalization, death, and retention in care.
6 secondary outcomes
Incidence of grade 3 to 5 clinical adverse events or serious adverse events
Time frame: Up to 24 weeks
24-week known survival
Time frame: 24 weeks
Incidence of cryptococcal meningitis
Time frame: Up to 24 weeks
Incidence of hospitalization
Time frame: Up to 24 weeks
Incidence of death
Time frame: Up to 24 weeks
Fluconazole adherence
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Cryptococcal Meningitis
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.
Radha Rajasingham, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immediate ART Initiation, Delayed ART Initiation and 10-Week Fluconazole in people with Cryptococcal Antigenemia and HIV-1-infection, run by University of Minnesota at 1 site in Uganda.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 3 Sep 2026. 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 Uganda. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Radha Rajasingham, MD (612-625-4680, radha@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-week cryptococcal meningitis-free survival with retention in care (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2026.