HIV Infected Population With Latent TuberculosisPhase 1NCT02771249
Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers
A Phase 1 study testing rifapentene (RPT), darunavir/cobicistat (DRV/c) and Isoniazid (INH) in people with HIV Infected Population With Latent Tuberculosis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
People with human immunodeficiency virus (HIV) often take several medicines to control HIV. Dolutegravir and darunavir boosted with cobicistat are HIV medicines that people may take. They may also need to take medicines for an infection called latent tuberculosis (TB). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infected Population With Latent Tuberculosis
- What is being tested?
- rifapentene (RPT), darunavir/cobicistat (DRV/c) and Isoniazid (INH)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2016to 17 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be considered eligible for this study only if all of the following criteria are met:
- Ages 18 - 65 years
- Weight greater than or equal to 45 kg and less than or equal to 120; BMI greater than or equal to 18.0 and <30
- Judged to be healthy based on medical history, physical examination, vital signs, and clinical laboratory tests (liver function tests (AST, ALT, Tbili) greater than or equal to upper limit of normal [ULN], serum creatinine (SCr) less than or equal to ULN, CK less than or equal to 2X ULN, platelets (PLT) >150,0000/mm3, hemoglobin (Hgb) >11 g/dL), C-reactive protein (CRP) less than or equal to ULN)
- Negative QuantiFERON-TB Gold test at screening
- HIV-negative, as determined by standard serologic assays for HIV infection.
Show all 16Show fewer
- No laboratory evidence of active Hepatitis A, B, or C infection
- Willing to abstain from alcohol consumption throughout the study period
- Subject agrees to genetic testing and storage of specimens for future research
- Negative serum or urine pregnancy test for females of child-bearing potential
- For female subjects able to become pregnant (i.e., have not undergone surgical sterilization or are not postmenopausal), willingness to prevent pregnancy during the study period by:
- Practicing absolute abstinence from sexual contact or
- Committing to use of effective non-hormonal and/or barrier methods of birth control during any and all sexual encounters. Acceptable methods are as follows:
- Condom, diaphragm, or cervical cap with a spermicide
- Intrauterine device (IUD) without hormones
- Male partner with a vasectomy
Who cannot join
- A subject will be ineligible for this study if 1, or more, of the following criteria are met:
- Known hypersensitivity to dolutegravir, darunavir, cobicistat, rifapentine and other rifamycin analogues, or isoniazid
- History of type 1 hypersensitivity reaction to sulfonamides
- History or presence of any of the following:
- Latent or active TB infection
- Gastrointestinal disease that is uncontrolled, requires daily treatment with medication, or would interfere with a subject s ability to absorb drugs (diarrhea, pancreatitis, peptic ulcer disease, etc.),
Show all 29Show fewer
- Renal impairment (chronic renal insufficiency of any CKD stage, or acute renal failure not induced by drug therapy defined as GFR < 90 ml/min)
- Respiratory disease that is uncontrolled or requires daily treatment with medication (asthma, chronic obstructive pulmonary disease, etc.)
- Cardiovascular disease (hypertension [systolic blood pressure >140 mmHg or diastolic blood pressure > 90 mmHg], heart failure, arrhythmia, etc.)
- Metabolic disorders (diabetes mellitus, etc.)
- Hematologic or bleeding disorders (anemia, hemophilia, serious/major bleeding events, menorrhagia (female subjects), etc.)
- Immunologic disorders
- Hormonal or endocrine disorders
- Psychiatric illness that would interfere with his or her ability to comply with study procedures or that requires daily treatment with medication
- Seizure disorder, with the exception of childhood febrile seizures
- Malignancy, or
- Any other condition that may interfere with the interpretation of the study results, or not be in the best interest of the subject in the opinion of the investigator
- Fasting total cholesterol >240 mg/dL or fasting triglycerides >240 mg/dL on 2 consecutive visits
- Fasting glucose >125 mg/dL on 2 consecutive visits
- Current participation in an onging investigational drug protocol or use of any investigational drug within 30 days (based on last dose received) prior to receipt of any study drugs/medications.
- Therapy with any prescription, over-the-counter, herbal, or holistic medications, including hormonal contraceptives by any route, within 5 half-lives of the agent prior to receipt of any study medications will not be permitted with the following exception: Intermittent or short-course therapy (< 14 days) with prescription or over-the-counter medications, herbals, or holistic medications within the screening period prior to starting study drug may be permitted, and will be reviewed by investigators on a case-by-case basis for potential drug interactions. Receipt of influenza vaccination will be allowed prior to, during, and/or after the study
- Inability to obtain venous access for sample collection
- Inability to swallow whole capsules and/or tablets
- Current breastfeeding
- Drug or alcohol use that may impair safety or adherence
- Use of nicotine-containing products, including cigarettes and chewing tobacco, nicotine patches, gum, electronic cigarettes, etc.
- Organ or stem cell transplant recipient
- Uncorrected and persistent electrolyte abnormalities (e.g., potassium, magnesium, and calcium)
- Current alcohol abuse or alcohol dependence disorders (DSM-5 criteria)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
People with human immunodeficiency virus (HIV) often take several medicines to control HIV. Dolutegravir and darunavir boosted with cobicistat are HIV medicines that people may take. They may also need to take medicines for an infection called latent tuberculosis (TB). Researchers think a once-weekly treatment for latent TB would be easier for people with HIV to take. This once weekly treatment consists of two drugs: rifapentine and isoniazid. However, they need to see how TB drugs and HIV drugs interact.
Objective:
Read more
To learn how anti-HIV and anti-TB drugs affect each other so that people taking these drugs together can be treated safely.
Eligibility:
Healthy adults ages 18 65.
Design:
Participants will be screened with a medical history and physical exam. They will have vital signs taken and give a blood sample. Women will have a pregnancy test.
Participants cannot take any other medicines during the study, including vitamins. Only occasional, infrequent use of acetaminophen (Tylenol , max 2000 mg/day), ibuprofen (Motrin or Advil ), naproxen (Aleve ), loperamide (Imodium ), and/or antihistamines (such as Benadryl , Zyrtec , Claritin , etc.) will be allowed.
Participants will be assigned to one of three groups. Each group will take a different study drug, once or twice a day, for 19 23 days. At the baseline study visit, they will get a supply of the study drug tablets and instructions for taking them. Participants will keep a medicine diary to serve as a memory aid for taking medicine and reporting any side effects that they may experience.
Participants will have 8 or 9 study visits over about 40 days. The number of visits depends on which group the person is assigned to. All visits will take place at the NIH Clinical Center. Participants will fast before study visits.
The baseline visit will last about 2 3 hours. There will be 3-4 long visits that will last for about 12 hours. The other 4-5 visits will last about 1 hour.
During all study visits, screening procedures will be repeated. During long visits, an intravenous (IV) line will be inserted into an arm vein with a needle. It will be used to take blood.
Read the detailed description
Rifapentine (RPT) is a long-acting rifamycin that can be used weekly with isoniazid (INH) as a first-line regimen in the treatment of latent tuberculosis infection (LTBI). Although this regimen offers several potential benefits, the use of weekly RPT plus INH is not currently recommended in adults infected with human immunodeficiency virus (HIV) on antiretroviral therapy (ART) due to limited evidence on drug interactions with antiretrovirals (ARVs).1Darunavir boosted with cobicistat (DRV/c) comprises part of alternative treatment regimens recommended for the treatment of HIV.2However, drug interactions between these ARV agents and RPT are of concern. Thus, the purpose of this study is to determine the effects of concomitant RPT and INH administration on the steady state PK of DRV/c.
This is an open-label, fixed sequence, intrasubject drug-drug interaction study designed to evaluate the steady state PK of DRV/c with coadministration of once weekly RPT and INH given at doses used to treat LTBI. Arm B will be comprised of two phases: (1) DRV/c once daily alone (days 1-4) and (2) DRV/c once daily + (RPT and INH) once weekly (days 5-19). Participants in Arm B will undergo periodic serial ARV PK blood draws on days 4, 14, and 19.
DRV/c PK parameters will be determined using non-compartmental methods. Cobicistat levels will only be assessed if DRV concentrations are significantly decreased. The following PK parameters will be compared between phases: area under the curve over the dosing interval, maximum plasma concentration, time to maximum plasma concentration, terminal half-life, apparent oral clearance, and minimum plasma concentration. Adverse events will be graded and recorded.
- Being tested
- rifapentene (RPT), darunavir/cobicistat (DRV/c), Isoniazid (INH), Pyridoxine
- Keywords
- Fixed Sequence, Intrasubject Drug-Drug Interaction, Open-Label
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rifapentene (RPT)Drug
RPT is a long-acting rifamycin used in combination with INH in the treatment of LTBI.
darunavir/cobicistat (DRV/c)Drug
DRV is a protease inhibitor (PI) indicated in the treatment of HIV infection.33 DRV requires coadministration with RTV (100 mg once or twice daily) or COBI (150 mg daily), the latter of which has been coformulated into a fixed-dose tablet with DRV (DRV/c 800/150 mg).
Isoniazid (INH)Drug
INH is an antimycobacterial agent that can be used alone or in combination with RPT for the treatment of LTBI. Given with Pyridoxine (vitamin B6)
PyridoxineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Arm B | Experimental | Arm B will be comprised of two phases: (1) DRV/c once daily alone (days 1-4) and (2) DRV/c once daily + RPT and INH once weekly (days 5-19). Receives: Drug: rifapentene (RPT); Drug: darunavir/cobicistat (DRV/c); Drug: Isoniazid (INH); Dietary Supplement: Pyridoxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area-under-the-curve during the dosing interval of 0 to t (AUC0-t), maximum total plasma concentration (Cmax), time to maximum plasma concentration (t-max), terminal halflife (t1/2), apparent oral clearance (CL/F)
To assess the effects of once weekly administration of RPT and INH given at doses used for treating LTBI on the steady state PK of DRV/c
Measured: Days 4 14, and 19
Secondary outcomes (1)
AEs and abnormal laboratory values graded according to the Division of AIDS AE Table, laboratory measures: hepatic & renal function, lipids, complete blood count, creatine kinase & lipase
To assess the safety of coadministration of DRV/c with once weekly RPT and INH through documentation of adverse events (AE) according to the Division of AIDS AE table
Measured: Day 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start3 Jun 2016
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV Infected Population With Latent TuberculosisStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joseph A Kovacs, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771249
- Sponsor's protocol ID
- 160112
- Other IDs
- 16-CC-0112
- Status last verified
- 28 Dec 2021
- First submitted
- 12 May 2016
- Last updated
- 18 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: .Individual participant data will not reported or shared. The study team are the only individuals who have access to individual participant data. All data will be analyzed and reported in aggregate.
Publications
Martinson NA, Barnes GL, Moulton LH, Msandiwa R, Hausler H, Ram M, McIntyre JA, Gray GE, Chaisson RE. New regimens to prevent tuberculosis in adults with HIV infection. N Engl J Med. 2011 Jul 7;365(1):11-20. doi: 10.1056/NEJMoa1005136.
PubMed 21732833Brooks KM, George JM, Pau AK, Rupert A, Mehaffy C, De P, Dobos KM, Kellogg A, McLaughlin M, McManus M, Alfaro RM, Hadigan C, Kovacs JA, Kumar P. Cytokine-Mediated Systemic Adverse Drug Reactions in a Drug-Drug Interaction Study of Dolutegravir With Once-Weekly Isoniazid and Rifapentine. Clin Infect Dis. 2018 Jul 2;67(2):193-201. doi: 10.1093/cid/ciy082.
PubMed 29415190
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Once-Weekly Rifapentine and Isoniazid on the Steady State Pharmacokinetics of Dolutegravir and Darunavir Boosted With Cobicistat in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02771249
- Acronym / sponsor ID
- 160112
- Keywords
- Fixed Sequence, Intrasubject Drug-Drug Interaction, Open-Label
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 3 Jun 2016 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 13 May 2016 (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.
People with human immunodeficiency virus (HIV) often take several medicines to control HIV. Dolutegravir and darunavir boosted with cobicistat are HIV medicines that people may take. They may also need to take medicines for an infection called latent tuberculosis (TB). Researchers think a once-weekly treatment for latent TB would be easier for people with HIV to take. This once weekly treatment consists of two drugs: rifapentine and isoniazid. However, they need to see how TB drugs and HIV drugs interact.
Objective:
To learn how anti-HIV and anti-TB drugs affect each other so that people taking these drugs together can be treated safely.
Eligibility:
Healthy adults ages 18 65.
Design:
Participants will be screened with a medical history and physical exam. They will have vital signs taken and give a blood sample. Women will have a pregnancy test.
Participants cannot take any other medicines during the study, including vitamins. Only occasional, infrequent use of acetaminophen (Tylenol , max 2000 mg/day), ibuprofen (Motrin or Advil ), naproxen (Aleve ), loperamide (Imodium ), and/or antihistamines (such as Benadryl , Zyrtec , Claritin , etc.) will be allowed.
Participants will be assigned to one of three groups. Each group will take a different study drug, once or twice a day, for 19 23 days. At the baseline study visit, they will get a supply of the study drug tablets and instructions for taking them. Participants will keep a medicine diary to serve as a memory aid for taking medicine and reporting any side effects that they may experience.
Participants will have 8 or 9 study visits over about 40 days. The number of visits depends on which group the person is assigned to. All visits will take place at the NIH Clinical Center. Participants will fast before study visits.
The baseline visit will last about 2 3 hours. There will be 3-4 long visits that will last for about 12 hours. The other 4-5 visits will last about 1 hour.
During all study visits, screening procedures will be repeated. During long visits, an intravenous (IV) line will be inserted into an arm vein with a needle. It will be used to take blood.
Detailed description
Rifapentine (RPT) is a long-acting rifamycin that can be used weekly with isoniazid (INH) as a first-line regimen in the treatment of latent tuberculosis infection (LTBI). Although this regimen offers several potential benefits, the use of weekly RPT plus INH is not currently recommended in adults infected with human immunodeficiency virus (HIV) on antiretroviral therapy (ART) due to limited evidence on drug interactions with antiretrovirals (ARVs).1Darunavir boosted with cobicistat (DRV/c) comprises part of alternative treatment regimens recommended for the treatment of HIV.2However, drug interactions between these ARV agents and RPT are of concern. Thus, the purpose of this study is to determine the effects of concomitant RPT and INH administration on the steady state PK of DRV/c.
This is an open-label, fixed sequence, intrasubject drug-drug interaction study designed to evaluate the steady state PK of DRV/c with coadministration of once weekly RPT and INH given at doses used to treat LTBI. Arm B will be comprised of two phases: (1) DRV/c once daily alone (days 1-4) and (2) DRV/c once daily + (RPT and INH) once weekly (days 5-19). Participants in Arm B will undergo periodic serial ARV PK blood draws on days 4, 14, and 19.
DRV/c PK parameters will be determined using non-compartmental methods. Cobicistat levels will only be assessed if DRV concentrations are significantly decreased. The following PK parameters will be compared between phases: area under the curve over the dosing interval, maximum plasma concentration, time to maximum plasma concentration, terminal half-life, apparent oral clearance, and minimum plasma concentration. Adverse events will be graded and recorded.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm B | Experimental | Drug: rifapentene (RPT), Drug: darunavir/cobicistat (DRV/c), Drug: Isoniazid (INH), Dietary Supplement: PyridoxineArm B will be comprised of two phases: (1) DRV/c once daily alone (days 1-4) and (2) DRV/c once daily + RPT and INH once weekly (days 5-19). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- A subject will be considered eligible for this study only if all of the following criteria are met:
- Ages 18 - 65 years
- Weight greater than or equal to 45 kg and less than or equal to 120; BMI greater than or equal to 18.0 and <30
- Judged to be healthy based on medical history, physical examination, vital signs, and clinical laboratory tests (liver function tests (AST, ALT, Tbili) greater than or equal to upper limit of normal [ULN], serum creatinine (SCr) less than or equal to ULN, CK less than or equal to 2X ULN, platelets (PLT) >150,0000/mm3, hemoglobin (Hgb) >11 g/dL), C-reactive protein (CRP) less than or equal to ULN)
- Negative QuantiFERON-TB Gold test at screening
Key exclusion criteria (29 listed)
- A subject will be ineligible for this study if 1, or more, of the following criteria are met:
- Known hypersensitivity to dolutegravir, darunavir, cobicistat, rifapentine and other rifamycin analogues, or isoniazid
- History of type 1 hypersensitivity reaction to sulfonamides
- History or presence of any of the following:
- Fasting total cholesterol >240 mg/dL or fasting triglycerides >240 mg/dL on 2 consecutive visits
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 |
|---|---|---|
| rifapentene (RPT)RPT is a long-acting rifamycin used in combination with INH in the treatment of LTBI. | Drug | Arm B |
| darunavir/cobicistat (DRV/c)DRV is a protease inhibitor (PI) indicated in the treatment of HIV infection.33 DRV requires coadministration with RTV (100 mg once or twice daily) or COBI (150 mg daily), the latter of which has been coformulated into a fixed-dose tablet with DRV (DRV/c 800/150 mg). | Drug | Arm B |
| Isoniazid (INH)INH is an antimycobacterial agent that can be used alone or in combination with RPT for the treatment of LTBI. Given with Pyridoxine (vitamin B6) | Drug | Arm B |
| Pyridoxine | Dietary supplement | Arm B |
Primary outcome
Area-under-the-curve during the dosing interval of 0 to t (AUC0-t), maximum total plasma concentration (Cmax), time to maximum plasma concentration (t-max), terminal halflife (t1/2), apparent oral clearance (CL/F)
Time frame: Days 4 14, and 19
To assess the effects of once weekly administration of RPT and INH given at doses used for treating LTBI on the steady state PK of DRV/c
1 secondary outcome
AEs and abnormal laboratory values graded according to the Division of AIDS AE Table, laboratory measures: hepatic & renal function, lipids, complete blood count, creatine kinase & lipase
Time frame: Day 34
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 18 Apr 2022.
- Background: PubMed 21732833Martinson NA, Barnes GL, Moulton LH, Msandiwa R, Hausler H, Ram M, McIntyre JA, Gray GE, Chaisson RE. New regimens to prevent tuberculosis in adults with HIV infection. N Engl J Med. 2011 Jul 7;365(1):11-20. doi: 10.1056/NEJMoa1005136.
- Derived from this study: PubMed 29415190Brooks KM, George JM, Pau AK, Rupert A, Mehaffy C, De P, Dobos KM, Kellogg A, McLaughlin M, McManus M, Alfaro RM, Hadigan C, Kovacs JA, Kumar P. Cytokine-Mediated Systemic Adverse Drug Reactions in a Drug-Drug Interaction Study of Dolutegravir With Once-Weekly Isoniazid and Rifapentine. Clin Infect Dis. 2018 Jul 2;67(2):193-201. doi: 10.1093/cid/ciy082.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. .Individual participant data will not reported or shared. The study team are the only individuals who have access to individual participant data. All data will be analyzed and reported in aggregate.
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.
Joseph A Kovacs, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rifapentene (RPT), darunavir/cobicistat (DRV/c) and Isoniazid (INH) in people with HIV Infected Population With Latent Tuberculosis, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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 16 inclusion and 29 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 18 Apr 2022. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Area-under-the-curve during the dosing interval of 0 to t (AUC0-t), maximum total plasma concentration (Cmax), time to maximum plasma concentration (t-max), terminal halflife (t1/2), apparent oral clearance (CL/F) (time frame: Days 4 14, and 19). 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 NCT02771249, which also lists 2 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 18 Apr 2022.