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HIV InfectionsPhase 3iPrExNCT00458393

Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men

A Phase 3 study testing daily TDF/FTC in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in 6 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

The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV counseling, condoms, and treatment for other sexually transmitted infections (STIs). Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
daily TDF/FTC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,499 participants
Where
11 sitesin 6 countries
Study dates
Jun 2007to Feb 2014
Phase
Phase 3
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 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male sex (at birth)
  • HIV uninfected
  • Age having reached the local age of consent
  • High risk for HIV infection including any of the following: 1) No condom use during anal intercourse with a male HIV-positive partner or a male partner of unknown HIV status during the last 6 months; (2) anal intercourse with more than 3 male sex partners during the last 6 months; (3) exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months; (4) sex with a male partner and STI diagnosis during the last 6 months or at screening, or (5) sexual partner of an HIV-infected man with whom condoms are not consistently used in the last 6 months.
  • Able to provide a street address of residence for themselves and one personal contact who would know their whereabouts during the study period
  • Healthy enough to work, as indicated by score of 80 or greater on the Karnofsky scale
Show all 12Show fewer
  • Certain laboratory values
  • A urine dipstick with a negative or trace result for both glucose and protein within 28 days of enrollment.
  • Ability to understand and local language for which an informed consent form has been approved by a local IRB and registered with the study sponsor.
  • Participated in a randomized, placebo-controlled, PrEP trail
  • Has been unblinded
  • Has provided informed consent

Who cannot join

  • Previously diagnosed active and serious infections, including tuberculosis infection, osteomyelitis, or infections requiring parenteral antibiotic therapy
  • Active clinically significant medical problems including heart disease (e.g., symptoms of ischemia, congestive heart failure, arrhythmia), lung disease (steroid-dependent chronic obstructive pulmonary disease), diabetes requiring hypoglycemic medication, or previously diagnosed cancer expected to require further treatment
  • Acute HBV infection at the screening visit or presence of treatment indications for hepatitis B based on local practice standards; or clinical signs of hepatic cirrhosis
  • History of pathological bone fractures not related to trauma
  • Receiving ongoing therapy with certain HIV/AIDS-related medications or other medications as determined by the investigator
  • Definitely or possibly received an anti-HIV vaccine while participating in a blinded clinical trial
Show all 11Show fewer
  • Current alcohol or drug use that, in the opinion of the investigator, may interfere with the study
  • Current participation in a clinical trial or cohort study other than sub-studies of this protocol
  • Any condition at enrollment that, in the opinion of the investigator, would make participation in the study unsafe or would interfere with the study
  • Sites may utilize additional criteria that restrict enrollment to a subset of people who meet the protocol-defined enrollment criteria.
  • Site leadership believes participant will have difficulty completing requirements

Trial locations and contacts

11 sites in 6 countries.

11 sites in 6 countries

United States3 sites

  • Fenway Community Health iPrEx CRS

    Boston, Massachusetts, 02215

  • Stroger Hospital of Cook County/Core Center IPREX CRS

    Chicago, Illinois, 60612

  • San Francisco Dept. of Public Health iPrEx CRS

    San Francisco, California, 94102

Other trials in United States

Brazil3 sites

  • IPEC/FIOCRUZ iPrEx CRS

    Rio de Janeiro, 21040-900

  • Projeto Praca Onze, Universidade Federal do Rio de Janeiro iPrEx CRS

    Rio de Janeiro, 21941.590

  • Universidade de Sao Paulo iPrEx CRS

    São Paulo, 05403

Other trials in Brazil

Peru2 sites

  • Asociación Civil Selva Amazónica, Iquitos, iPrEx CRS

    Iquitos, Maynas

  • Investigaciones Médicas en Salud (INMENSA), Lince, iPrEx CRS

    Lima

Other trials in Peru

Ecuador1 site

  • Fundación Ecuatoriana Equidad, Guayaquil, iPrEx CRS

    Guayaquil, Guayas

Other trials in Ecuador

South Africa1 site

  • Desmond Tutu HIV Ctr. iPrEx CRS

    Cape Town, 7925

Other trials in South Africa

Thailand1 site

  • Research Institute for Health Sciences iPrEx CRS

    Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: Chemoprophylaxis for HIV Prevention in Men

The purpose of this study is to determine whether daily use of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) can prevent HIV infection in men who also receive HIV counseling, condoms, and treatment for other sexually transmitted infections (STIs).

Read the detailed description

The Joint United Nations Programme on AIDS estimates that 14,000 persons are newly infected with HIV every day worldwide; one half of these infections occur in people between the ages of 15 and 24. New infections occur despite widespread awareness of the modes of HIV transmission and the protection afforded by condom use. Effective interventions for HIV prevention are urgently needed. This study will evaluate the safety and efficacy of chemoprophylaxis for HIV prevention in men who have sex with men (MSM) who are at high risk for HIV infection despite using condoms, receiving HIV counseling, and receiving treatment for STIs, particularly hepatitis B virus (HBV) infection. A daily combination dose of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) has been selected for evaluation because it has a well-established safety record in previous studies and was demonstrated to be effective for HIV prevention in primate models. These medications have long half-lives that allow daily dosing and do not have known interactions with hormonal contraception, methadone, or tuberculosis therapies.

Once on the study drug, participants will be followed for a variable length of time, starting within 4 weeks of their screening visit and lasting up to 144 weeks. All participants will be followed for at least 8 weeks after stopping study drug. Participants who are reactive to a Hepatitis B surface antigen (HBsAg) test will be followed for hepatic flares for 16 additional weeks for a total of 24 weeks after stopping study drug. If enrolled in the optional substudy of bone mineral density, fat distribution, and fasting lipids, the participant will be asked to return for one additional visit 24 weeks after stopping study drug. Participants who HIV seroconvert during their participation will also be followed until the end of the study.

All study visits will be at 4 week intervals. At study entry, high risk, HIV uninfected MSM will be randomly assigned to receive either daily FTC/TDF or placebo, in addition to standard HIV counseling, condoms, and sexually transmitted infection (STI) management. The study will closely monitor biological and behavioral safety, including careful analysis of drug resistance, kidney and liver function, and risk behavior.

At the screening visit, participants will undergo HIV antibody and HBV testing, a medical history, a medical exam, blood and urine collection, risk behavior assessment, and STI testing. At study entry, participants will be given study medication; tested for HCV; and offered the HBV vaccine, if applicable. At all study visits, there will be HIV antibody testing, pill counts, adherence checks, study medication distribution, HIV counseling, and condom distribution. A medical history and blood will be taken on selected visits, along with STI testing and treatment if needed. Testing and treatment of STIs will be provided at no cost to the participant.

All study participants will be encouraged to join a substudy that will assess interactions between HBV infection, bone mineral density and fat distribution, and immune function. If enrolled in the substudy, the participant will be asked to return for one additional visit 24 weeks after stopping the study medication. All participants in the substudy will undergo dual energy x-ray absorptiometry (DEXA) scans, and HIV infected participants will undergo additional blood collection.

Sites will have the option of participating in the following four substudies:

The Hair Substudy: Participants who are receiving FTC/TDF will be eligible to enroll. At each 12-week follow-up study visit, hair samples will be collected and questionnaires will be completed.

The Urine Substudy: For all participants who elect to enroll in this substudy, additional testing will occur on blood and urine samples collected at each 24-week follow-up visit. An additional urine collection will occur 8 weeks after participants stop receiving FTC/TDF.

The Semen Substudy: Participants who seroconvert during the study may elect to participate in this substudy. One semen sample will be collected at participants' next study visit when plasma viral load testing is performed.

The Gonorrhea and Chlamydia Substudy: Participants in this substudy will undergo rectal and oropharyngeal swab procedures and urine collection at the 24-week study visit.

After the randomized phase ends, if the daily oral FTC/TDF arm is shown to be beneficial and safe, participants will be given the option of participating in an open label extension phase. During this extension phase, study participants will receive daily oral open-label FTC/TDF, in addition to standard counseling, condoms, and STI management.

Conditions
HIV Infections
Being tested
daily TDF/FTC, Placebo
Keywords
HIV, Chemoprophylaxis, Hepatitis, Viral human hepatitis, HIV Seronegativity
Medical subject headings
HIV Infections, Hepatitis, Hepatitis, Viral, Human

What participants receive

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

  • daily TDF/FTCDrug

    Also called truvada

    daily oral medication

  • PlaceboDrug

    daily oral medication

Study groups in NCT00458393
Study groupRoleWhat they receive
TDF/FTCExperimentalDrug. Daily oral tablet of co-formulated 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate (TDF/FTC).
Receives: Drug: daily TDF/FTC
PlaceboPlacebo comparatorDrug. Daily oral placebo
Receives: Drug: Placebo

What is being measured

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

  1. HIV Seroconversion

    Confirmed HIV infection

    Measured: Monthly follow-up through a median of 1.2 years

  2. Grade 1 or Higher Creatinine Toxicity

    Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf

    Measured: Duration of follow-up, median 1.2 years

  3. Grade 3 or Higher Phosphorous Toxicity

    Grade 3 or higher phosphorous toxicity (hypophosphatemia) by the Division of AIDS Grading Table (severe, level at or below 1.9 mg/dL)

    Measured: The entire follow-up period, median 1.2 years

  4. Grade 2, 3, or 4 Laboratory Adverse Events

    Number of participants with at least one Grade 2, 3, or 4 laboratory adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf

    Measured: Entire follow-up, median 1.2 years

  5. Grade 2, 3, or 4 Clinical Adverse Events

    Number of participants with at least 1 Grade 2, 3, or 4 clinical adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table_for_grading_severity_of_adult_pediatric_adverse_events.pdf

    Measured: Entire follow-up, median 1.2 years

Secondary outcomes (16)

  1. Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis

    A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to >5 fold upper limit of normal at any visit, or an increase to >2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug.

    More details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/

    Measured: Quarterly lab tests through a median follow-up of 1.2 years

  2. Percentage Change in Bone Mineral Density

    % Change from baseline in bone mineral density (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in in hip and L1-L4 spine by dual-energy x-ray absorptiometry

    Measured: baseline and week 24.

  3. Percentage Change in Body Fat

    Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Body Fat from Baseline by dual-energy x-ray absorptiometry

    Measured: Baseline and Week 24

  4. Percentage Change in Fasting Triglycerides

    Percentage Change (Percentage Change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in Triglycerides from Baseline from a fasting sample.

    Measured: Baseline and Week 24

  5. Percent Change in Total Cholesterol

    Percent change (100 * [(value at 24 weeks- value at baseline)/ (value at baseline)]) in fasting total cholesterol from baseline

    Measured: Baseline and Week 24

  6. Viral Load Among HIV Infected Participants

    HIV-RNA in log10 units among HIV infected participants at the time closest to HIV detection

    Measured: At the time closest to HIV detection

  7. Among HIV Infected Participants Drug Resistance

    Genotypic resistance by clinical assays among the seroconverters from baseline to the end of the study treatment period

    Measured: at the time of HIV acquisition

  8. CD4 Count Among HIV Infected Participants

    CD4 cell count for HIV infected participants during the trial

    Measured: at the time infection was detected

  9. Proportion of Missed Doses by Pill Count

    Estimated proportion of missed doses by pill count (assuming pills taken in unreturned bottles)

    Measured: At 24 weeks

  10. Percentage of Missed Doses by Estimate During CASI Interview

    Percentage of missed doses by estimate during computer assisted structured interview

    Measured: Week 24

  11. Number of Condomless Sexual Partners With HIV Positive or Unknown Status

    Participants self-report of the number of sexual partners with HIV positive or unknown status in the previous 12 weeks with whom they had condomless anal sex

    Measured: At 24 weeks

  12. Total Number of Sexual Partners

    Self-reported total number of sexual partners in the previous 12 weeks.

    Measured: 24 weeks

  13. Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status.

    Self-reported condomless receptive anal intercourse in the previous 12 weeks with any partners regardless of status.

    Measured: At 24 weeks

  14. Incidence of Confirmed Syphilis During Follow-Up

    Number of participants who have at least 1 confirmed syphilis infection during the study

    Measured: All Follow-Up median of 1.2 years of follow-up

  15. Incidence of HSV-2 During the Follow-up Period

    Incidence of HSV-2 during the follow-up period among those HIV-2 negative at baseline

    Measured: Total study follow-up, a median of 1.2 years

  16. Diagnosis of Gonorrhea During the Follow-up Period

    Diagnosis of gonorrhea during the follow-up period by PCR

    Measured: All of follow-up period, median of 1.2 years

Timeline

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

  1. First posted10 Apr 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,499 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00458393
Sponsor's protocol ID
CO-US-104-0288
Other IDs
10445, 1U01AI064002, iPrEx
Acronym
iPrEx
Status last verified
Oct 2021
First submitted
6 Apr 2007
Last updated
2 Nov 2021
Data monitoring committee
Yes

Publications

  • Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.

    PubMed 21091279

  • Zivich PN, Cole SR, Edwards JK, Glidden DV, Das M, Shook-Sa BE, Shao Y, Mehrotra ML, Adimora AA, Eron JJ. HIV Prevention Among Men Who Have Sex With Men: Tenofovir Alafenamide Combination Preexposure Prophylaxis Versus Placebo. J Infect Dis. 2024 Apr 12;229(4):1123-1130. doi: 10.1093/infdis/jiad507.

    PubMed 37969014

  • Mehrotra ML, Westreich D, McMahan VM, Glymour MM, Geng E, Grant RM, Glidden DV. Baseline Characteristics Explain Differences in Effectiveness of Randomization to Daily Oral TDF/FTC PrEP Between Transgender Women and Cisgender Men Who Have Sex With Men in the iPrEx Trial. J Acquir Immune Defic Syndr. 2019 Jul 1;81(3):e94-e98. doi: 10.1097/QAI.0000000000002037. No abstract available.

    PubMed 31192894

  • Glidden DV, Mulligan K, McMahan V, Anderson PL, Guanira J, Chariyalertsak S, Buchbinder SP, Bekker LG, Schechter M, Grinsztejn B, Grant RM. Metabolic Effects of Preexposure Prophylaxis With Coformulated Tenofovir Disoproxil Fumarate and Emtricitabine. Clin Infect Dis. 2018 Jul 18;67(3):411-419. doi: 10.1093/cid/ciy083.

    PubMed 29415175

  • Glidden DV, Mulligan K, McMahan V, Anderson PL, Guanira J, Chariyalertsak S, Buchbinder SP, Bekker LG, Schechter M, Grinsztejn B, Grant RM. Brief Report: Recovery of Bone Mineral Density After Discontinuation of Tenofovir-Based HIV Pre-exposure Prophylaxis. J Acquir Immune Defic Syndr. 2017 Oct 1;76(2):177-182. doi: 10.1097/QAI.0000000000001475.

    PubMed 28639995

  • Gandhi M, Glidden DV, Mayer K, Schechter M, Buchbinder S, Grinsztejn B, Hosek S, Casapia M, Guanira J, Bekker LG, Louie A, Horng H, Benet LZ, Liu A, Grant RM. Association of age, baseline kidney function, and medication exposure with declines in creatinine clearance on pre-exposure prophylaxis: an observational cohort study. Lancet HIV. 2016 Nov;3(11):e521-e528. doi: 10.1016/S2352-3018(16)30153-9. Epub 2016 Aug 31.

    PubMed 27658870

  • Castillo-Mancilla J, Seifert S, Campbell K, Coleman S, McAllister K, Zheng JH, Gardner EM, Liu A, Glidden DV, Grant R, Hosek S, Wilson CM, Bushman LR, MaWhinney S, Anderson PL. Emtricitabine-Triphosphate in Dried Blood Spots as a Marker of Recent Dosing. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6692-6697. doi: 10.1128/AAC.01017-16. Print 2016 Nov.

    PubMed 27572401

  • Glidden DV, Amico KR, Liu AY, Hosek SG, Anderson PL, Buchbinder SP, McMahan V, Mayer KH, David B, Schechter M, Grinsztejn B, Guanira J, Grant RM. Symptoms, Side Effects and Adherence in the iPrEx Open-Label Extension. Clin Infect Dis. 2016 May 1;62(9):1172-7. doi: 10.1093/cid/ciw022. Epub 2016 Jan 20.

    PubMed 26797207

  • Mulligan K, Glidden DV, Anderson PL, Liu A, McMahan V, Gonzales P, Ramirez-Cardich ME, Namwongprom S, Chodacki P, de Mendonca LM, Wang F, Lama JR, Chariyalertsak S, Guanira JV, Buchbinder S, Bekker LG, Schechter M, Veloso VG, Grant RM; Preexposure Prophylaxis Initiative Study Team. Effects of Emtricitabine/Tenofovir on Bone Mineral Density in HIV-Negative Persons in a Randomized, Double-Blind, Placebo-Controlled Trial. Clin Infect Dis. 2015 Aug 15;61(4):572-80. doi: 10.1093/cid/civ324. Epub 2015 Apr 23.

    PubMed 25908682

  • Liu A, Glidden DV, Anderson PL, Amico KR, McMahan V, Mehrotra M, Lama JR, MacRae J, Hinojosa JC, Montoya O, Veloso VG, Schechter M, Kallas EG, Chariyalerstak S, Bekker LG, Mayer K, Buchbinder S, Grant R; iPrEx Study team. Patterns and correlates of PrEP drug detection among MSM and transgender women in the Global iPrEx Study. J Acquir Immune Defic Syndr. 2014 Dec 15;67(5):528-37. doi: 10.1097/QAI.0000000000000351.

    PubMed 25230290

  • Liegler T, Abdel-Mohsen M, Bentley LG, Atchison R, Schmidt T, Javier J, Mehrotra M, Eden C, Glidden DV, McMahan V, Anderson PL, Li P, Wong JK, Buchbinder S, Guanira JV, Grant RM; iPrEx Study Team. HIV-1 drug resistance in the iPrEx preexposure prophylaxis trial. J Infect Dis. 2014 Oct 15;210(8):1217-27. doi: 10.1093/infdis/jiu233. Epub 2014 Apr 16.

    PubMed 24740633

  • Buchbinder SP, Glidden DV, Liu AY, McMahan V, Guanira JV, Mayer KH, Goicochea P, Grant RM. HIV pre-exposure prophylaxis in men who have sex with men and transgender women: a secondary analysis of a phase 3 randomised controlled efficacy trial. Lancet Infect Dis. 2014 Jun;14(6):468-75. doi: 10.1016/S1473-3099(14)70025-8. Epub 2014 Mar 7.

    PubMed 24613084

  • Amico KR, Mansoor LE, Corneli A, Torjesen K, van der Straten A. Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. AIDS Behav. 2013 Jul;17(6):2143-55. doi: 10.1007/s10461-013-0429-9.

    PubMed 23435697

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing daily TDF/FTC in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in 6 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 12 inclusion and 11 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Brazil, Peru, Ecuador, South Africa and 1 more country. 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.

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?

Yes. Results are posted in the registry (first posted 24 Jan 2018). 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 Seroconversion (time frame: Monthly follow-up through a median of 1.2 years). The study lists 5 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 NCT00458393, which also lists 13 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 2 Nov 2021.

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