HIV InfectionsNCT01066858
Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in 4 countries.
Trial summary
The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and while breastfeeding. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- What is being tested?
- Tenofovir disoproxil fumarate (TDF)
- How many people
- 1,765 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 22 Mar 2011to 30 Nov 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: For antepartum (AP) exposure part of P1084s: Mother/infant pairs enrolled in the antepartum components of 1077BF or 1077FF (1077BA and 1077FA respectively) at African clinical sites approved as P1084s DXA sites. For postpartum (PP) exposure part of P1084s: Mothers and their infants enrolled in the postpartum component of 1077BF (107BP) at African clinical sites approved as P1084s DXA sites.
Who may be able to join
- Mother-infant pair enrolled in 1077BA or 1077FA
- At a clinical site that has been approved as a P1084s DXA site
- Enrolled in the substudy up to the Week 2 visit of 1077BA/1077FA (within 21 days after 1077BA/1077FA study entry) and prior to the start of labor
- Willing and able to provide written informed consent to participate in this substudy
- Mother and their infant enrolled in 1077BP
- At a clinical site that has been approved as a P1084s DXA site
- Enrolled in the substudy within 6 to 14 days of delivery, on the same day as enrollment in 1077BP
- Willing and able to provide written informed consent to participate in this substudy
Who cannot join
- None
- Postpartum (PP) Part of Substudy (TDF Exposure During Breastfeeding) (Note: this applies only to the new enrollment to P1084s, i.e., those who were not enrolled to P1084s while on the AP component)
- TDF exposure during pregnancy [NOTE: TDF use for up to 12 days beginning at labor allowed]
- Enrolled in the AP part of P1084s
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
South Africa5 sites
Durban Paediatric HIV CRS
Durban, KwaZulu-Natal, 4001
Umlazi CRS
Durban, KwaZulu-Natal, 4001
Soweto IMPAACT CRS
Johannesburg, Gauteng, 1862
Shandukani Research CRS
Johannesburg, Gauteng, 2001
Family Clinical Research Unit (FAM-CRU) CRS
Tygerberg, Western Cape, 7505
Zimbabwe3 sites
Seke North CRS
Chitungwiza
St Mary's CRS
Chitungwiza
Harare Family Care CRS
Harare
About this study
Official title: Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere)
The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and while breastfeeding. The study will also look at the changes in overall health, bone health and how the kidneys work in the infants of these women.
Read the detailed description
A small number of adults (who are not pregnant) and children who take anti-HIV medications develop problems with their kidneys and with the strength of their bones. These problems may be more common when tenofovir disoproxil fumarate (TDF) is used. Studies about these bone and kidney effects have not been done in pregnant and breastfeeding women and their infants.
This is a substudy of a larger study (IMPAACT 1077 PROMISE [Promoting Maternal and Infant Survival Everywhere]) to evaluate the safety of anti-HIV medications used in pregnancy and during breastfeeding. Only participants in the larger study randomly assigned to receive maternal tenofovir disoproxil fumarate (TDF) or no maternal TDF during pregnancy or during breastfeeding will be enrolled in this substudy.
This substudy will look at two groups of participants:
- An antepartum exposure group to look at the effects of TDF during pregnancy
- A postpartum exposure group to look at the effects of TDF during breastfeeding
All mother-infant pairs in the substudy will be followed for 74 weeks after delivery. During this time, the women and their infants will have medical checkups and tests. The tests will include tests of blood, urine, cord blood, and breast milk. Some of the women and infants will have a special x-ray called a dual energy e-ray absorptiometry (DXA) scan to measure bone strength. The timing of the tests-at enrollment, at delivery, at 6, 10, 26, or 74 weeks-will vary dependent on which part of this substudy women and infants are enrolled in. Those in charge of the substudy will try to schedule medical visits and tests at the same time as tests scheduled for the larger IMPAACT 1077 study.
- Conditions
- HIV Infections
- Being tested
- Tenofovir disoproxil fumarate (TDF)
- Keywords
- tenofovir, renal and bone toxicity, pregnancy, breastfeeding, mother to child transmission
- Medical subject headings
- HIV Infections, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxil fumarate (TDF)Drug
Some participants will receive varying doses of TDF during pregnancy or breastfeeding as part of the larger study (IMPAACT 1077 PROMISE).
| Study group | Role | What they receive |
|---|---|---|
| Maternal/infant antepartum exposure | * HIV-infected women exposed to TDF during pregnancy
* Infants of HIV-infected women exposed to TDF during pregnancy Receives: Drug: Tenofovir disoproxil fumarate (TDF) | |
| Maternal/infant postpartum exposure | * HIV-infected women exposed to TDF while breastfeeding
* Infants of HIV-infected women exposed to TDF while breastfeeding Receives: Drug: Tenofovir disoproxil fumarate (TDF) | |
| Maternal/infant antepartum no exposure | * HIV-infected women not exposed to TDF during pregnancy * Infants of HIV-infected women not exposed to TDF during pregnancy | |
| Maternal/infant postpartum no exposure | * HIV-infected women not exposed to TDF during breastfeeding * Infants of HIV-infected women not exposed to TDF during breastfeeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antepartum Component: Creatinine clearance (CrCl)
Antepartum Component: Creatinine clearance (CrCl)
Measured: For women and infants: at delivery/birth, up to Week 1
Antepartum Component: Bone resorption (Dpyr)
Antepartum Component: Bone resorption (Dpyr)
Measured: For women and infants: at delivery/birth, up to Week 1
Antepartum Component: Lumbar spine bone mineral density (BMD) via dual energy e-ray absorptiometry (DXA)
Antepartum Component: Lumbar spine bone mineral density (BMD) via dual energy e-ray absorptiometry (DXA)
Measured: For women: at delivery/birth, up to Week 1
Antepartum Component: Lumbar spine bone mineral content (BMC) and whole body BMC via DXA
Antepartum Component: Lumbar spine bone mineral content (BMC) and whole body BMC via DXA
Measured: For infants: at delivery/birth, up to Week 1
Antepartum Component: Length-for-age Z-score
Antepartum Component: Length-for-age Z-score
Measured: For infants: at delivery/birth, up to Week 1 and Week 26
Postpartum Component: CrCl
Postpartum Component: CrCl
Measured: For women: at postpartum entry (delivery/birth, up to Week 1) and Week 74; for infants: at Week 26
Postpartum Component: Dpyr
Postpartum Component: Dpyr
Measured: For women: at Week 74; for infants: at Week 26
Postpartum Component: Lumbar spine BMD via DXA
Postpartum Component: Lumbar spine BMD via DXA
Measured: For women: at postpartum entry (delivery/birth, up to Week 1) and Week 74
Postpartum Component: Lumbar spine BMC via DXA
Postpartum Component: Lumbar spine BMC via DXA
Measured: For infants: at Week 26
Postpartum Component: Length-for-age Z-score
Postpartum Component: Length-for-age Z-score
Measured: For infants: at postpartum entry (delivery/birth, up to Week 1) and Week 26
Secondary outcomes (7)
CrCl
CrCl
Measured: For women: Weeks 6, 26, and 74; for infants: at Weeks 10, 26, and 74
BMD
BMD
Measured: For women: at delivery and change in hip BMD from delivery to Week 74
Dpyr
Dpyr
Measured: For women: at Weeks 6, 26, and 74; for infants: at Weeks 10, 26, and 74
Mineral composition of breast milk
Mineral composition of breast milk
Measured: For women: at Weeks 1, 6, 26, and 74
Lumbar spine BMC
Lumbar spine BMC
Measured: For infants: Week 26
Infant growth
Infant growth
Measured: For infants: at Weeks 10 and 74
Concentration of hormonal growth factors (for infants)
Concentration of hormonal growth factors (for infants)
Measured: For infants: at birth and Weeks 10, 26, and 74
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study start22 Mar 2011
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,765 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- George K. Siberry, MD, MPH, Study chair, NICHD/NIHLynda Stranix-Chibanda, MBChB, MMED, Study chair, University of Zimbabwe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066858
- Sponsor's protocol ID
- P1084s (PROMISE)
- Other IDs
- 10790, IMPAACT P1084s
- Status last verified
- Sep 2022
- First submitted
- 9 Feb 2010
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Foster C, Lyall H, Olmscheid B, Pearce G, Zhang S, Gibb DM. Tenofovir disoproxil fumarate in pregnancy and prevention of mother-to-child transmission of HIV-1: is it time to move on from zidovudine? HIV Med. 2009 Aug;10(7):397-406. doi: 10.1111/j.1468-1293.2009.00709.x. Epub 2009 May 12.
PubMed 19459986Nurutdinova D, Onen NF, Hayes E, Mondy K, Overton ET. Adverse effects of tenofovir use in HIV-infected pregnant women and their infants. Ann Pharmacother. 2008 Nov;42(11):1581-5. doi: 10.1345/aph.1L083. Epub 2008 Oct 28.
PubMed 18957630Baltrusaitis K, Makanani B, Tierney C, Fowler MG, Moodley D, Theron G, Nyakudya LH, Tomu M, Fairlie L, George K, Heckman B, Knowles K, Browning R, Siberry GK, Taha TE, Stranix-Chibanda L; PROMISE P1084s Study Team. Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial. BMC Infect Dis. 2022 Jul 20;22(1):634. doi: 10.1186/s12879-022-07608-8.
PubMed 35858874Stranix-Chibanda L, Tierney C, Sebikari D, Aizire J, Dadabhai S, Zanga A, Mukwasi-Kahari C, Vhembo T, Violari A, Theron G, Moodley D, George K, Fan B, Sommer MJ, Browning R, Mofenson LM, Shepherd J, Nelson B, Fowler MG, Siberry GK; PROMISE P1084s study team. Impact of postpartum tenofovir-based antiretroviral therapy on bone mineral density in breastfeeding women with HIV enrolled in a randomized clinical trial. PLoS One. 2021 Feb 5;16(2):e0246272. doi: 10.1371/journal.pone.0246272. eCollection 2021.
PubMed 33544759
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Infant Monitoring for Evidence of Toxicity Related to Tenofovir Exposure: The Bone and Kidney Health Substudy of the IMPAACT 1077 PROMISE Protocol (Promoting Maternal and Infant Survival Everywhere)
- ClinicalTrials.gov ID
- NCT01066858
- Acronym / sponsor ID
- P1084s (PROMISE)
- Conditions
- HIV Infections
- Keywords
- tenofovir, renal and bone toxicity, pregnancy, breastfeeding, mother to child transmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,765 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Gilead Sciences
- Study start
- 22 Mar 2011 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 10 Feb 2010 (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 look at the effects of tenofovir disoproxil fumarate (an anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and while breastfeeding. The study will also look at the changes in overall health, bone health and how the kidneys work in the infants of these women.
Detailed description
A small number of adults (who are not pregnant) and children who take anti-HIV medications develop problems with their kidneys and with the strength of their bones. These problems may be more common when tenofovir disoproxil fumarate (TDF) is used. Studies about these bone and kidney effects have not been done in pregnant and breastfeeding women and their infants.
This is a substudy of a larger study (IMPAACT 1077 PROMISE [Promoting Maternal and Infant Survival Everywhere]) to evaluate the safety of anti-HIV medications used in pregnancy and during breastfeeding. Only participants in the larger study randomly assigned to receive maternal tenofovir disoproxil fumarate (TDF) or no maternal TDF during pregnancy or during breastfeeding will be enrolled in this substudy.
This substudy will look at two groups of participants:
- An antepartum exposure group to look at the effects of TDF during pregnancy
- A postpartum exposure group to look at the effects of TDF during breastfeeding
All mother-infant pairs in the substudy will be followed for 74 weeks after delivery. During this time, the women and their infants will have medical checkups and tests. The tests will include tests of blood, urine, cord blood, and breast milk. Some of the women and infants will have a special x-ray called a dual energy e-ray absorptiometry (DXA) scan to measure bone strength. The timing of the tests-at enrollment, at delivery, at 6, 10, 26, or 74 weeks-will vary dependent on which part of this substudy women and infants are enrolled in. Those in charge of the substudy will try to schedule medical visits and tests at the same time as tests scheduled for the larger IMPAACT 1077 study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Maternal/infant antepartum exposure | – | Drug: Tenofovir disoproxil fumarate (TDF)* HIV-infected women exposed to TDF during pregnancy * Infants of HIV-infected women exposed to TDF during pregnancy |
| Maternal/infant postpartum exposure | – | Drug: Tenofovir disoproxil fumarate (TDF)* HIV-infected women exposed to TDF while breastfeeding * Infants of HIV-infected women exposed to TDF while breastfeeding |
| Maternal/infant antepartum no exposure | – | –* HIV-infected women not exposed to TDF during pregnancy * Infants of HIV-infected women not exposed to TDF during pregnancy |
| Maternal/infant postpartum no exposure | – | –* HIV-infected women not exposed to TDF during breastfeeding * Infants of HIV-infected women not exposed to TDF during breastfeeding |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- For antepartum (AP) exposure part of P1084s: Mother/infant pairs enrolled in the antepartum components of 1077BF or 1077FF (1077BA and 1077FA respectively) at African clinical sites approved as P1084s DXA sites. For postpartum (PP) exposure part of P1084s: Mothers and their infants enrolled in the postpartum component of 1077BF (107BP) at African clinical sites approved as P1084s DXA sites.
Key inclusion criteria (8 listed)
- Mother-infant pair enrolled in 1077BA or 1077FA
- At a clinical site that has been approved as a P1084s DXA site
- Enrolled in the substudy up to the Week 2 visit of 1077BA/1077FA (within 21 days after 1077BA/1077FA study entry) and prior to the start of labor
- Willing and able to provide written informed consent to participate in this substudy
- Mother and their infant enrolled in 1077BP
Key exclusion criteria (4 listed)
- None
- Postpartum (PP) Part of Substudy (TDF Exposure During Breastfeeding) (Note: this applies only to the new enrollment to P1084s, i.e., those who were not enrolled to P1084s while on the AP component)
- TDF exposure during pregnancy [NOTE: TDF use for up to 12 days beginning at labor allowed]
- Enrolled in the AP part of P1084s
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 |
|---|---|---|
| Tenofovir disoproxil fumarate (TDF)Some participants will receive varying doses of TDF during pregnancy or breastfeeding as part of the larger study (IMPAACT 1077 PROMISE). | Drug | Maternal/infant antepartum exposure, Maternal/infant postpartum exposure |
Primary outcome
Antepartum Component: Creatinine clearance (CrCl)
Time frame: For women and infants: at delivery/birth, up to Week 1
Antepartum Component: Creatinine clearance (CrCl)
Antepartum Component: Bone resorption (Dpyr)
Time frame: For women and infants: at delivery/birth, up to Week 1
Antepartum Component: Bone resorption (Dpyr)
Antepartum Component: Lumbar spine bone mineral density (BMD) via dual energy e-ray absorptiometry (DXA)
Time frame: For women: at delivery/birth, up to Week 1
Antepartum Component: Lumbar spine bone mineral density (BMD) via dual energy e-ray absorptiometry (DXA)
Antepartum Component: Lumbar spine bone mineral content (BMC) and whole body BMC via DXA
Time frame: For infants: at delivery/birth, up to Week 1
Antepartum Component: Lumbar spine bone mineral content (BMC) and whole body BMC via DXA
Antepartum Component: Length-for-age Z-score
Time frame: For infants: at delivery/birth, up to Week 1 and Week 26
Antepartum Component: Length-for-age Z-score
Postpartum Component: CrCl
Time frame: For women: at postpartum entry (delivery/birth, up to Week 1) and Week 74; for infants: at Week 26
Postpartum Component: CrCl
Postpartum Component: Dpyr
Time frame: For women: at Week 74; for infants: at Week 26
Postpartum Component: Dpyr
Postpartum Component: Lumbar spine BMD via DXA
Time frame: For women: at postpartum entry (delivery/birth, up to Week 1) and Week 74
Postpartum Component: Lumbar spine BMD via DXA
Postpartum Component: Lumbar spine BMC via DXA
Time frame: For infants: at Week 26
Postpartum Component: Lumbar spine BMC via DXA
Postpartum Component: Length-for-age Z-score
Time frame: For infants: at postpartum entry (delivery/birth, up to Week 1) and Week 26
Postpartum Component: Length-for-age Z-score
7 secondary outcomes
CrCl
Time frame: For women: Weeks 6, 26, and 74; for infants: at Weeks 10, 26, and 74
BMD
Time frame: For women: at delivery and change in hip BMD from delivery to Week 74
Dpyr
Time frame: For women: at Weeks 6, 26, and 74; for infants: at Weeks 10, 26, and 74
Mineral composition of breast milk
Time frame: For women: at Weeks 1, 6, 26, and 74
Lumbar spine BMC
Time frame: For infants: Week 26
Infant growth
Time frame: For infants: at Weeks 10 and 74
Concentration of hormonal growth factors (for infants)
Time frame: For infants: at birth and Weeks 10, 26, and 74
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 23 Sep 2022.
- Background: PubMed 19459986Foster C, Lyall H, Olmscheid B, Pearce G, Zhang S, Gibb DM. Tenofovir disoproxil fumarate in pregnancy and prevention of mother-to-child transmission of HIV-1: is it time to move on from zidovudine? HIV Med. 2009 Aug;10(7):397-406. doi: 10.1111/j.1468-1293.2009.00709.x. Epub 2009 May 12.
- Background: PubMed 18957630Nurutdinova D, Onen NF, Hayes E, Mondy K, Overton ET. Adverse effects of tenofovir use in HIV-infected pregnant women and their infants. Ann Pharmacother. 2008 Nov;42(11):1581-5. doi: 10.1345/aph.1L083. Epub 2008 Oct 28.
- Derived from this study: PubMed 35858874Baltrusaitis K, Makanani B, Tierney C, Fowler MG, Moodley D, Theron G, Nyakudya LH, Tomu M, Fairlie L, George K, Heckman B, Knowles K, Browning R, Siberry GK, Taha TE, Stranix-Chibanda L; PROMISE P1084s Study Team. Maternal and infant renal safety following tenofovir disoproxil fumarate exposure during pregnancy in a randomized control trial. BMC Infect Dis. 2022 Jul 20;22(1):634. doi: 10.1186/s12879-022-07608-8.
- Derived from this study: PubMed 33544759Stranix-Chibanda L, Tierney C, Sebikari D, Aizire J, Dadabhai S, Zanga A, Mukwasi-Kahari C, Vhembo T, Violari A, Theron G, Moodley D, George K, Fan B, Sommer MJ, Browning R, Mofenson LM, Shepherd J, Nelson B, Fowler MG, Siberry GK; PROMISE P1084s study team. Impact of postpartum tenofovir-based antiretroviral therapy on bone mineral density in breastfeeding women with HIV enrolled in a randomized clinical trial. PLoS One. 2021 Feb 5;16(2):e0246272. doi: 10.1371/journal.pone.0246272. eCollection 2021.
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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.
George K. Siberry, MD, MPH study chair
NICHD/NIH
Lynda Stranix-Chibanda, MBChB, MMED study chair
University of Zimbabwe
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in 4 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 4 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 23 Sep 2022. 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 South Africa, Zimbabwe, Malawi, 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.
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?
Antepartum Component: Creatinine clearance (CrCl) (time frame: For women and infants: at delivery/birth, up to Week 1). The study lists 10 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 NCT01066858, which also lists 4 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 23 Sep 2022.