HIV InfectionsNCT01539226

Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women

A study testing Dapivirine Vaginal Ring, 25 mg in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring. Read more about this study

Who is it for?: Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Dapivirine Vaginal Ring, 25 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,959 participants
Where: 7 sitesin 2 countries
Study dates: 27 Mar 2012to 13 Dec 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Women > 18 and < 45 years of age, at screening, who can provide informed consent;
Available for all visits and consent to follow all procedures scheduled for the trial;
Self-reported sexually active (defined as an average of at least one penetrative penile-vaginal coital act per month for the last 3 months prior to screening);
HIV-negative as determined by the HIV algorithm applied at screening and enrolment;
On a stable form of contraception as defined within section 5.4 and willing to continue on stable contraception for the duration of the clinical trial, unless post-menopausal or surgically sterilised;
Asymptomatic for genital infections at the time of enrolment (if a woman is diagnosed with any clinically significant curable STI, she must have initiated treatment at least 1 week prior to enrolment and have completed the full course of treatment);
Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures (e.g., by home visit or telephone; or via family or close neighbour contacts); confidentiality to be maintained;
Willing to refrain from participation in another research trial using drugs, vaccines, medical devices, microbicides or oral pre-exposure prophylaxis investigational drugs for the duration of the IPM 027 trial.

Who cannot join

Currently pregnant or last pregnancy within 3 months prior to screening or intends to become pregnant during trial participation;
Currently breast-feeding;
Non-therapeutic injection drug use in the 12 months prior to screening;
Participated in another research trial using drugs, medical devices, microbicides or oral pre-exposure prophylaxis agents within 60 days prior to screening;
Previously participated or currently participating in any HIV vaccine trial;
Untreated, clinically significant urogenital infections , e.g., urinary tract, or other sexually transmitted infections, or other gynaecological symptoms within 1 week prior to enrolment;

Show all 14Show fewer

Has a Grade 2 or higher pelvic examination finding, according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events; Addendum 1 Female Genital Grading Table for Use in Microbicide Studies;
History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, diagnosed chronic and/or recurrent vulvovaginal candidiasis, urethral obstruction, incontinence or urge incontinence;
Any gynaecological surgery within 90 days prior to screening;
Any Grade 1 or higher baseline aspartate aminotransferase (AST), alanine transaminase (ALT), or platelet count, and any Grade 2 or higher baseline haematology, chemistry or urinalysis laboratory value according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events;
Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex or a silicone elastomer;
Any history of diabetes mellitus and chronic use of oral corticosteroid therapy; and any uncontrolled serious chronic or progressive disease;
Cervical cytology at screening that requires cryotherapy, biopsy or treatment (other than for infection). Women with Grade 1 cervical cytology findings can be enrolled upon completion of the initial phase of evaluation if no current treatment is indicated (based on local standard of care for management of abnormal cervical cytology);
Any condition(s) that, in the opinion of the investigator, might put the participant at risk, or interfere with the trial objectives or the participant's adherence to trial requirements.

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

South Africa6 sites

Madibeng Centre for Research (MCR)
Brits, 0250
Desmond Tutu HIV Foundation, Guinea Fowl Road, Sunnydale, Fish Hoek
Cape Town, 7975
Ndlovu Medical Centre
Elandsdoorn, Limpopo, 0485
Qhakaza Mbokodo
Ladysmith, KwaZulu-Natal
Prevention of HIV / AIDS (PHIVA) Project
Pinetown, KwaZulu-Natal, 3610
Maternal, Adolescent and Child Health (MatCH)
Plessislaer, 3216

Other trials in South Africa

Uganda1 site

MRC/UVRI Uganda Research Unit on AIDS, Plot 51-59, Nakiwogo Road, PO BOX 49
Masaka

Other trials in Uganda

About this study

Official title: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women

This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.

Read the detailed description

A multi center, randomized, double-blind, placebo=controlled safety and efficacy trial of a Dapivirine Vaginal Matrix Ring in healthy HIV-negative women.

Conditions: HIV Infections
Being tested: Placebo Vaginal Ring, Dapivirine Vaginal Ring, 25 mg
Keywords: HIV Infections, Anti-HIV agents, HIV-1
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo Vaginal RingCombination product
Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
Dapivirine Vaginal Ring, 25 mgCombination product
Dapivirine Vaginal Ring containing 25 mg of dapivirine

Study groups in NCT01539226
Study group	Role	What they receive
Placebo Vaginal Ring	Placebo comparator	Vaginal Ring containing 0.0 mg Dapivirine Receives: Combination Product: Placebo Vaginal Ring
Dapivirine Vaginal Ring	Experimental	Vaginal Ring containing 25mg of Dapivirine Receives: Combination Product: Dapivirine Vaginal Ring, 25 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm.
HIV-1 seroconversion measured by rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm.
Measured: 24 months
All Adverse Events
Self-reports, physical examination, gynaecological assessments, including pelvic/speculum examination, laboratory tests and other indicated investigations. All AEs will be reported, regardless of grade or relatedness.
Measured: 24 months

Secondary outcomes (6)

The Incidence Rate of HIV-2 Seroconversion.
Rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm in Appendix C of protocol.
Measured: 24 months
The Incidence of Curable STIs
The percentage of participants testing positive for any STI (gonorrhoea, chlamydia, trichomonas, syphilis) will be assessed.
Measured: 24 months
Percentage of Participants With Pregnancy in Each Trial Arm Over the IP Use Period;
The percentage of participants with pregnancies in each treatment group. For each treatment group, the numerator will include the number of participants that had a positive urine pregnancy test during the trial period.
Measured: 24 months
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Questionnaires and qualitative data regarding sexual behaviour and adherence to the use of a vaginal ring inserted once every 4 weeks over the trial period.
Dapivirine residual levels in used rings and dapivirine plasma concentrations are two objective measures of adherence to DVR ring use,
Measured: 24 months
The Percentage of Women Who Report the Use of the Vaginal Ring as Acceptable;
Questionnaires and qualitative data regarding the acceptability of use of a vaginal ring inserted once every 4 weeks over the trial period; Number of participants with positive response. Response of 'likely' or 'very likely' to the question: 'If in the future a vaginal ring was available that provided some protection against HIV, and it was similar to the one you used in this trial, how likely would you be to keep it inserted in your vagina every day?'
Measured: 24 months
The Percentage of Participants With HIV-1 Drug Resistance Mutations Among Participants Who Acquire HIV-1.
The analysis of HIV-1 drug resistance will be primarily descriptive in nature, and will depend on the pattern of resistance mutations observed in the HIV-1 seroconverters. The proportion of HIV-1 seroconverters with at least one HIV-1 drug resistant mutation will be presented overall, and by treatment arm, with corresponding 95% CIs.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 201213 Dec 2016

First posted27 Feb 2012 (estimated)
Study start27 Mar 2012
Primary completion13 Dec 2016
Study completion13 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,959 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01539226
Sponsor's protocol ID: IPM 027
Status last verified: Jul 2022
First submitted: 21 Feb 2012
Last updated: 19 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Abaasa AM, Kusemererwa S. Incremental value of non-pharmacokinetic adherence measures for dapivirine vaginal ring use in resource limited setting. Trials. 2026 Jun 11. doi: 10.1186/s13063-026-09838-6. Online ahead of print.
PubMed 42277878
Kusemererwa S, Ruzagira E, Onyango M, Kabarambi A, Abaasa A. Associations between intravaginal practices and incidence of sexually transmitted infections and bacterial vaginosis among women enrolled in the dapivirine vaginal ring trial (The Ring Study) in southwestern Uganda: a retrospective secondary analysis. BMJ Open. 2024 Apr 8;14(4):e079497. doi: 10.1136/bmjopen-2023-079497.
PubMed 38589266
Steytler J, Craig C, van der Ryst E, Van Baelen B, Nuttall J, van Niekerk N, Mellors J, Parikh U, Wallis C; Ring Study and the DREAM Trial Study Teams. Characterization of Viruses in Phase 3 and Phase 3b Trials (the Ring Study and the Dapivirine Ring Extended Access and Monitoring Trial) of the Dapivirine Vaginal Ring for Human Immunodeficiency Virus Type 1 Infection Risk Reduction. Clin Infect Dis. 2023 Mar 21;76(6):996-1002. doi: 10.1093/cid/ciac875.
PubMed 36345569
Kusemererwa S, Abaasa A, Kabarambi A, Onyango M, Mugisha JO. Assessment of risk compensation following use of the dapivirine vaginal ring in southwestern Uganda. Sex Transm Infect. 2022 Feb;98(1):32-37. doi: 10.1136/sextrans-2020-054718. Epub 2021 Feb 4.
PubMed 33542153
Kusemererwa S, Abaasa A, Onyango M, Nel AM, Isaacs M, Asiki G. Contraceptive Preference Among Women at Risk of HIV Acquisition in a Preparatory Screening Study for a Phase III Microbicide Trial in South Western Uganda. AIDS Behav. 2018 Jul;22(Suppl 1):131-138. doi: 10.1007/s10461-018-2177-3.
PubMed 29855975
Nel A, van Niekerk N, Kapiga S, Bekker LG, Gama C, Gill K, Kamali A, Kotze P, Louw C, Mabude Z, Miti N, Kusemererwa S, Tempelman H, Carstens H, Devlin B, Isaacs M, Malherbe M, Mans W, Nuttall J, Russell M, Ntshele S, Smit M, Solai L, Spence P, Steytler J, Windle K, Borremans M, Resseler S, Van Roey J, Parys W, Vangeneugden T, Van Baelen B, Rosenberg Z; Ring Study Team. Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women. N Engl J Med. 2016 Dec 1;375(22):2133-2143. doi: 10.1056/NEJMoa1602046.
PubMed 27959766

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Safety and Efficacy Trial of a Dapivirine Vaginal Matrix Ring in Healthy HIV-Negative Women
ClinicalTrials.gov ID: NCT01539226
Acronym / sponsor ID: IPM 027
Conditions: HIV Infections
Keywords: HIV Infections, Anti-HIV agents, HIV-1
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,959 participants (actual)
Lead sponsor: International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
Study start: 27 Mar 2012 (actual)
Primary completion: 13 Dec 2016 (actual)
Study completion: 13 Dec 2016 (actual)
First posted: 27 Feb 2012 (estimated)
Results: Posted 19 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a double-blind, randomised, placebo-controlled study to assess the safety and efficacy of a silicone elastomer vaginal matrix ring.

Detailed description

A multi center, randomized, double-blind, placebo=controlled safety and efficacy trial of a Dapivirine Vaginal Matrix Ring in healthy HIV-negative women.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo Vaginal Ring	Placebo comparator	Combination Product: Placebo Vaginal RingVaginal Ring containing 0.0 mg Dapivirine
Dapivirine Vaginal Ring	Experimental	Combination Product: Dapivirine Vaginal Ring, 25 mgVaginal Ring containing 25mg of Dapivirine

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Women > 18 and < 45 years of age, at screening, who can provide informed consent;
Available for all visits and consent to follow all procedures scheduled for the trial;
Self-reported sexually active (defined as an average of at least one penetrative penile-vaginal coital act per month for the last 3 months prior to screening);
HIV-negative as determined by the HIV algorithm applied at screening and enrolment;
On a stable form of contraception as defined within section 5.4 and willing to continue on stable contraception for the duration of the clinical trial, unless post-menopausal or surgically sterilised;

Key exclusion criteria (14 listed)

Currently pregnant or last pregnancy within 3 months prior to screening or intends to become pregnant during trial participation;
Currently breast-feeding;
Non-therapeutic injection drug use in the 12 months prior to screening;
Participated in another research trial using drugs, medical devices, microbicides or oral pre-exposure prophylaxis agents within 60 days prior to screening;
Previously participated or currently participating in any HIV vaccine trial;

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
Placebo Vaginal RingDapivirine Vaginal Ring containing 0.0 mg of dapivirine	Combination product	Placebo Vaginal Ring
Dapivirine Vaginal Ring, 25 mgDapivirine Vaginal Ring containing 25 mg of dapivirine	Combination product	Dapivirine Vaginal Ring

Primary outcome

HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm.
Time frame: 24 months
HIV-1 seroconversion measured by rapid and specialised laboratory testing according to the comprehensive HIV testing algorithm.
All Adverse Events
Time frame: 24 months
Self-reports, physical examination, gynaecological assessments, including pelvic/speculum examination, laboratory tests and other indicated investigations. All AEs will be reported, regardless of grade or relatedness.

6 secondary outcomes

The Incidence Rate of HIV-2 Seroconversion.
Time frame: 24 months
The Incidence of Curable STIs
Time frame: 24 months
Percentage of Participants With Pregnancy in Each Trial Arm Over the IP Use Period;
Time frame: 24 months
The Percentage of Women Who Report Adherence to the Use of the Vaginal Ring Inserted Once Every 4 Weeks Over the Trial Period;
Time frame: 24 months
The Percentage of Women Who Report the Use of the Vaginal Ring as Acceptable;
Time frame: 24 months
The Percentage of Participants With HIV-1 Drug Resistance Mutations Among Participants Who Acquire HIV-1.
Time frame: 24 months

Results and safety

Results posted to the registry on 19 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Vaginal Ring	652	435
Dapivirine Vaginal Ring	1,307	902

Primary outcome: HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm.

Time frame: 24 months. Count of participants. Unit: Participants

Measure	Dapivirine Vaginal Ring n = 1302	Placebo Vaginal Ring n = 650
Value	82	61

Population analysed: This population consisted of all participants included in the ITT population (all randomised), excluding those who were not identified as HIV-seropositive at the Enrollment Visit, but who were later found to be already HIV-1 infected at enrollment through HIV-1 RNA PCR testing.

Primary outcome: All Adverse Events

Time frame: 24 months. Count of participants. Unit: Participants

Measure	Dapivirine Vaginal Ring n = 1306	Placebo Vaginal Ring n = 652
Value	1147	561

Population analysed: The safety population included all participants who had been randomized to IP and used at least one DVR or placebo ring.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 years and 9 months During the double-blind treatment period, the median (range) number of days of ring exposure was 764.0 (28 - 826) days in participants in the DVR group and 763.5 (8 - 839) days in participants in the placebo ring group.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Vaginal Ring	9 of 652 (1.4%)	561 of 652 (86%)	3 of 652
Dapivirine Vaginal Ring	41 of 1,306 (3.1%)	1,147 of 1,306 (87.8%)	2 of 1,306

Limitations and caveats (from the sponsor): Dapivirine residual levels in used rings and dapivirine plasma concentrations are two objective measures of adherence to DVR ring use; however, they were found to be an imperfect measure of adherence as they cannot distinguish different patterns of use during the month. In addition, self-reported adherence based on the adherence questionnaires was also considered to have limitations.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42277878Abaasa AM, Kusemererwa S. Incremental value of non-pharmacokinetic adherence measures for dapivirine vaginal ring use in resource limited setting. Trials. 2026 Jun 11. doi: 10.1186/s13063-026-09838-6. Online ahead of print.
Derived from this study: PubMed 38589266Kusemererwa S, Ruzagira E, Onyango M, Kabarambi A, Abaasa A. Associations between intravaginal practices and incidence of sexually transmitted infections and bacterial vaginosis among women enrolled in the dapivirine vaginal ring trial (The Ring Study) in southwestern Uganda: a retrospective secondary analysis. BMJ Open. 2024 Apr 8;14(4):e079497. doi: 10.1136/bmjopen-2023-079497.
Derived from this study: PubMed 36345569Steytler J, Craig C, van der Ryst E, Van Baelen B, Nuttall J, van Niekerk N, Mellors J, Parikh U, Wallis C; Ring Study and the DREAM Trial Study Teams. Characterization of Viruses in Phase 3 and Phase 3b Trials (the Ring Study and the Dapivirine Ring Extended Access and Monitoring Trial) of the Dapivirine Vaginal Ring for Human Immunodeficiency Virus Type 1 Infection Risk Reduction. Clin Infect Dis. 2023 Mar 21;76(6):996-1002. doi: 10.1093/cid/ciac875.
Derived from this study: PubMed 33542153Kusemererwa S, Abaasa A, Kabarambi A, Onyango M, Mugisha JO. Assessment of risk compensation following use of the dapivirine vaginal ring in southwestern Uganda. Sex Transm Infect. 2022 Feb;98(1):32-37. doi: 10.1136/sextrans-2020-054718. Epub 2021 Feb 4.
Derived from this study: PubMed 29855975Kusemererwa S, Abaasa A, Onyango M, Nel AM, Isaacs M, Asiki G. Contraceptive Preference Among Women at Risk of HIV Acquisition in a Preparatory Screening Study for a Phase III Microbicide Trial in South Western Uganda. AIDS Behav. 2018 Jul;22(Suppl 1):131-138. doi: 10.1007/s10461-018-2177-3.
Derived from this study: PubMed 27959766Nel A, van Niekerk N, Kapiga S, Bekker LG, Gama C, Gill K, Kamali A, Kotze P, Louw C, Mabude Z, Miti N, Kusemererwa S, Tempelman H, Carstens H, Devlin B, Isaacs M, Malherbe M, Mans W, Nuttall J, Russell M, Ntshele S, Smit M, Solai L, Spence P, Steytler J, Windle K, Borremans M, Resseler S, Van Roey J, Parys W, Vangeneugden T, Van Baelen B, Rosenberg Z; Ring Study Team. Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women. N Engl J Med. 2016 Dec 1;375(22):2133-2143. doi: 10.1056/NEJMoa1602046.
Individual participant dataSharing planned: No

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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.

Annalene Nel study director

Beijing Immupeutics Medicine Technology Limited

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dapivirine Vaginal Ring, 25 mg in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 7 sites in 2 countries.

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 8 inclusion and 14 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 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Africa, 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 19 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

HIV-1 Seroconversion According to Comprehensive HIV Testing Algorithm. (time frame: 24 months). 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?

On the ClinicalTrials.gov record for NCT01539226, which also lists 6 linked publications.

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 19 Oct 2022.