HIV InfectionsPhase 2NCT04692077
Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males
A Phase 2 study testing Cabotegravir (CAB) tablet, CAB LA and Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people. Read more about this study
- Who is it for?
- Ages Up to 17 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Cabotegravir (CAB) tablet, CAB LA and Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Feb 2020to 7 Jul 2023
- Phase
- Phase 2
- 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 Up to 17 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Assigned male at birth (includes MSM, TGW, and gender non-conforming people)
- At enrollment, aged below 18 years
- At enrollment, body weight ≥ 35 kg (77 lbs.)
- Willing to provide informed consent for the study
- Self-reported sexual activity with a male in the past 12 months
- In general, good health, as evidenced by the following laboratory values
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- Non-reactive/negative HIV test results
- Absolute neutrophil count > 799 cells/mm3
- Platelet count ≥ 100,000 cells/mm3
- Hemoglobin ≥ 11g/dL
- Calculated creatinine clearance ≥ 60 mL/minute using modified Schwartz equation (≤ grade 2)
- Alanine aminotransferase (ALT) < 2.0 times the upper limit of normal (ULN) and total bilirubin (Tbili) ≤ 2.5 x ULN
- Hepatitis B virus (HBV) surface antigen (HBsAg) negative and accepts vaccination
- Hepatitis C virus (HCV) Antibody negative
- Willing to undergo all required study procedures
- If currently on pre-exposure prophylaxis (PrEP) from a non-study source, willing to stop said PrEP prior to enrollment and agree to switch to oral CAB for the lead-in period and CAB LA injections.
Who cannot join
- Co-enrollment in any other HIV interventional research study or other concurrent studies which may interfere with this study (as provided by self-report or other available documentation)
- Past or current participation in HIV vaccine trial with exception for participants who can provide documentation of receipt of placebo
- Exclusively had sex with biological females in lifetime
- In the last 6 months (at the time of screening): active or planned use of any substance which would, in the opinion of the site investigator, would hinder study participation (including herbal remedies), as described in the Investigator's Brochure (IB) or listed in the Study Specific Procedures (SSP), and/ or Protocol Section 4.4
- Known history of clinically significant cardiovascular disease, as defined by history/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease
- Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections
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- Tattoo or other dermatological condition overlying the buttock region that may interfere with interpretation of injection site reactions
- Current or chronic history of liver disease (e.g., non-alcoholic or alcoholic steatohepatitis) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome, asymptomatic gallstones, or cholecystectomy)
- Known history of clinically significant bleeding
- Surgically-placed or injected buttock implants or fillers, per self-report. Contact the CMC for guidance regarding questions about individual cases
- A history of seizure disorder, per self-report
- Medical, social, or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or the safety of the participant (e.g., provided by self-report, or found upon medical history and examination or in available medical records)
- Plans to move out of the geographic area within the next 18 months or otherwise unable to participate in study visits, according to the site investigator.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Colorado Denver ATN CRS
Aurora, Colorado, 80045
The Fenway Institute ATN CRS
Boston, Massachusetts, 02215
John H. Stroger Jr. Hosp. of Cook County ATN CRS
Chicago, Illinois, 60612
St. Jude Children's Research Hosp. ATN CRS
Memphis, Tennessee, 38105
About this study
Official title: Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083
This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.
Read the detailed description
The purpose of this study is to establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.
This study will enroll healthy, HIV-uninfected adolescents assigned male at birth, including men who have sex with men (MSM), transgender women (TGW), and gender non-conforming people. The total participant commitment for the entire study is approximately 1.5 years.
This study will take place in three steps. In Step 1, participants will receive daily oral CAB tablets for 5 weeks. In Step 2, participants will receive a series of five intramuscular (IM) injections of CAB LA, administered at 8-week intervals after a 4-week loading dose (injections at Weeks 5, 9, 17, 25 \& 33). A safety visit will follow each injection to ascertain safety data, including injection site reactions. In Step 3, all participants who have received at least one injection will be followed quarterly (every 3 months) for 48 weeks after their last injection. Participants will receive oral TDF/FTC for daily use for 48 weeks or may be provided the opportunity to enroll in a local open label study of CAB, if available.
Participants will attend about 18 study visits throughout the study. Visits may include physical examinations, blood collection, urine collection, rectal and oral pharyngeal swab collection, risk reduction and adherence counseling, and behavioral or acceptability assessments.
- Conditions
- HIV Infections
- Being tested
- Cabotegravir (CAB) tablet, CAB LA, Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet
- Keywords
- Pre-Exposure Prophylaxis, PrEP
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir (CAB) tabletDrug
30 mg tablets
CAB LADrug
Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter.
Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tabletDrug
300 mg/200 mg fixed-dose combination tablets
| Study group | Role | What they receive |
|---|---|---|
| CAB LA | Experimental | In Step 1, participants will receive one CAB tablet orally every day for 5 weeks. In Step 2, participants will receive an intramuscular (IM) injection of CAB LA at Weeks 5, 9, 17, 25, and 33. In Step 3, participants will receive a TDF/FTC tablet orally every day for 48 weeks or may be offered the opportunity to join an open label CAB study instead, if such a study is being implemented in their area at the time. Receives: Drug: Cabotegravir (CAB) tablet; Drug: CAB LA; Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint: Proportion of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Among Participants Who Receive at Least One Injection of CAB LA.
Number and percent of participants experiencing any Grade 2 or higher clinical adverse events (AEs) or laboratory abnormalities (reported as adverse events) from the first injection visit to 8 weeks after the last Step 2 injection visit, or Week 41, whichever comes first.
Measured: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.
Tolerability Endpoint: Proportion of Participants Who Receive at Least 1 Injection and Who Discontinue Receiving Injections Prior to the Full Course of Injections Due to Intolerability of Injection, Frequency of Injections or Burden of Study Procedures.
Number and percent of participants who receive at least 1 injection and who discontinue receiving injections prior to the full course of injections due to intolerability of injection or burden of study procedures. Reasons for intolerability may include:
- Injection site reaction
- Burden of study procedure
- Participant refused further participation
- Participant is unwilling or unable to comply with required study procedures
- Participant refused further study product use
- Participant unable to adhere to visit schedule
Measured: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.
Acceptability Endpoint: Proportion of Participants Who Complete All Scheduled Injections and Proportion of Participants Who Receive at Least One Injection Whom Would Consider Using CAB LA for HIV Prevention in the Future.
Definition of completing all scheduled injections for participants who are confirmed HIV positive or discontinue product due to the following reasons:
- Death
- Early study closure
- HBV infection
During Step 2:
Both enrolled and injection populations: completed all injections whose target window closed prior to death/seroconversion/product discontinuation date
Measured: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.
Secondary outcomes (8)
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90)
CAB drug concentrations will be measured in plasma to generate CAB-LA concentration-time profiles among study participants. Measurements will occur at study visits during the injection phase of the study as well as during the pharmacologic "tail" phase. Count of participants for injection visits in which a participant remains above the 1x (0.166 mcg/mL), 4x (0.664 mcg/mL) and 8x (1.33 mcg/mL) PA-IC90.Concentrations above the 3 PA-IC90 are associated with rectal protection in a non-human primate study, and concentrations above the 8x PA-IC90 are expected to be associated with protection in humans.
Measured: Measured from the participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41
Measure Study Product Concentrations in Enrolled Participants With HPTN Laboratory Center (LC) Confirmed HIV Infection Throughout Study.
For infections occurring prior to (or on the first day of) Step 3, we will include visit level plasma CAB concentrations, for individual seroconverters. For infections occurring after the start of Step 3, we will include visit level plasma CAB concentrations as well as concentrations of TFV and TFV-DP (if applicable).
Measured: Measured through seroconverter's first Oral visit up through end of study participation (step1, 2, 3)
Count and Percentage of Participants Experiencing Grade 2 or Higher Clinical AEs and LaboratoryAbnormalities in the Oral Phase and the Aggregate Oral and Injection Phases
Number and percent of participants experiencing any Grade 2 or higher clinical adverse events (AEs) or laboratory abnormalities from:
- enrollment to week 5 (oral phase (step 1), including interim visits).
- enrollment to 8 weeks following the last injection received (aggregate over oral + injection phases (step 1-step 2) including interim visits)
Measured: Measured through participant's first oral visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.
Proportion of Participants Receiving One or More Injections Who Experience Grade 2 or Higher Clinical AEs and Laboratory Abnormalities From Initial Injection to 36 Weeks Later.
Number and percent of participants experiencing any Grade 2 or higher clinical adverse events (AEs) or laboratory abnormalities from the first injection visit to approximately 36 weeks later regardless of whether participants received all 5 injections.
Measured: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.
Proportion of Injection Visits That Occurred "On-time".
Number and percentage of injections given, using the number of injections expected as the denominator. while the number and percent of injection visits (up to 5 per participant) that occur "on-time", using the number of injections given as the denominator. This will be presented along with the total number and percent of injections given, among all intended injections (i.e. 5 injections per participant).
Those who have been terminated, are HIV infected, or have permanently discontinued study products at the time of visit will be excluded from the number of expected injections.
Measured: Measured through participant's last step 2 injection.
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period
Counts of sexual partners will be summarized (mean and sd) at enrollment and each regular Step 1 and Step 2 follow-up visit (W4, W5, W9, W17, W25, W33).
Measured: Measured through participant's first oral visit up to last Step 2 injection visit.
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period
Counts of episodes of anal intercourse without a condom will be summarized (mean and sd) at enrollment and each regular Step 1 and Step 2 follow-up visit (W4, W5, W9, W17, W25, W33).
Measured: Measured through participant's first oral visit up to the last Step 2 injection visit.
Evaluate Rates of HIV Drug Resistance Among Participants Who Acquire HIV Infection During the Study
Data from steps 1, 2, and 3 will be included. The number of cases of drug resistance will be summarized. All cases of drug resistance among incident HIV infections will be described.
Measured: Measured through participant's last study visit, up to approximately 1.5 years after study entry.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start19 Feb 2020
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sybil Hosek, PhD, Study chair, Stroger Hospital of Cook CountyLynda Stranix-Chibanda, MBChB, MMED, Study chair, University of Zimbabwe College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692077
- Sponsor's protocol ID
- HPTN 083-01
- Other IDs
- 38654
- Status last verified
- May 2025
- First submitted
- 22 Dec 2020
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males - A Sub-study of HPTN 083
- ClinicalTrials.gov ID
- NCT04692077
- Acronym / sponsor ID
- HPTN 083-01
- Conditions
- HIV Infections
- Keywords
- Pre-Exposure Prophylaxis, PrEP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Posted 29 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.
Detailed description
The purpose of this study is to establish the minimum safety, tolerability and acceptability data needed to support the use of cabotegravir long-acting injection (CAB LA) in an adolescent population, potentially transforming the field of HIV prevention for young people.
This study will enroll healthy, HIV-uninfected adolescents assigned male at birth, including men who have sex with men (MSM), transgender women (TGW), and gender non-conforming people. The total participant commitment for the entire study is approximately 1.5 years.
This study will take place in three steps. In Step 1, participants will receive daily oral CAB tablets for 5 weeks. In Step 2, participants will receive a series of five intramuscular (IM) injections of CAB LA, administered at 8-week intervals after a 4-week loading dose (injections at Weeks 5, 9, 17, 25 \& 33). A safety visit will follow each injection to ascertain safety data, including injection site reactions. In Step 3, all participants who have received at least one injection will be followed quarterly (every 3 months) for 48 weeks after their last injection. Participants will receive oral TDF/FTC for daily use for 48 weeks or may be provided the opportunity to enroll in a local open label study of CAB, if available.
Participants will attend about 18 study visits throughout the study. Visits may include physical examinations, blood collection, urine collection, rectal and oral pharyngeal swab collection, risk reduction and adherence counseling, and behavioral or acceptability assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAB LA | Experimental | Drug: Cabotegravir (CAB) tablet, Drug: CAB LA, Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tabletIn Step 1, participants will receive one CAB tablet orally every day for 5 weeks. In Step 2, participants will receive an intramuscular (IM) injection of CAB LA at Weeks 5, 9, 17, 25, and 33. In Step 3, participants will receive a TDF/FTC tablet orally every day for 48 weeks or may be offered the opportunity to join an open label CAB study instead, if such a study is being implemented in their area at the time. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (16 listed)
- Assigned male at birth (includes MSM, TGW, and gender non-conforming people)
- At enrollment, aged below 18 years
- At enrollment, body weight ≥ 35 kg (77 lbs.)
- Willing to provide informed consent for the study
- Self-reported sexual activity with a male in the past 12 months
Key exclusion criteria (13 listed)
- Co-enrollment in any other HIV interventional research study or other concurrent studies which may interfere with this study (as provided by self-report or other available documentation)
- Past or current participation in HIV vaccine trial with exception for participants who can provide documentation of receipt of placebo
- Exclusively had sex with biological females in lifetime
- In the last 6 months (at the time of screening): active or planned use of any substance which would, in the opinion of the site investigator, would hinder study participation (including herbal remedies), as described in the Investigator's Brochure (IB) or listed in the Study Specific Procedures (SSP), and/ or Protocol Section 4.4
- Known history of clinically significant cardiovascular disease, as defined by history/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease
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 |
|---|---|---|
| Cabotegravir (CAB) tablet30 mg tablets | Drug | CAB LA |
| CAB LAAdministered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter. | Drug | CAB LA |
| Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet300 mg/200 mg fixed-dose combination tablets | Drug | CAB LA |
Primary outcome
Safety Endpoint: Proportion of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Among Participants Who Receive at Least One Injection of CAB LA.
Time frame: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.
Number and percent of participants experiencing any Grade 2 or higher clinical adverse events (AEs) or laboratory abnormalities (reported as adverse events) from the first injection visit to 8 weeks after the last Step 2 injection visit, or Week 41, whichever comes first.
Tolerability Endpoint: Proportion of Participants Who Receive at Least 1 Injection and Who Discontinue Receiving Injections Prior to the Full Course of Injections Due to Intolerability of Injection, Frequency of Injections or Burden of Study Procedures.
Time frame: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.
Number and percent of participants who receive at least 1 injection and who discontinue receiving injections prior to the full course of injections due to intolerability of injection or burden of study procedures. Reasons for intolerability may include: 1. Injection site reaction 2. Burden of study procedure 1. Participant refused further participation 2. Participant is unwilling or unable to comply with required study procedures 3. Participant refused further study product use 4. Participant unable to adhere to visit schedule
Acceptability Endpoint: Proportion of Participants Who Complete All Scheduled Injections and Proportion of Participants Who Receive at Least One Injection Whom Would Consider Using CAB LA for HIV Prevention in the Future.
Time frame: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.
Definition of completing all scheduled injections for participants who are confirmed HIV positive or discontinue product due to the following reasons: * Death * Early study closure * HBV infection During Step 2: Both enrolled and injection populations: completed all injections whose target window closed prior to death/seroconversion/product discontinuation date
8 secondary outcomes
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90)
Time frame: Measured from the participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41
Measure Study Product Concentrations in Enrolled Participants With HPTN Laboratory Center (LC) Confirmed HIV Infection Throughout Study.
Time frame: Measured through seroconverter's first Oral visit up through end of study participation (step1, 2, 3)
Count and Percentage of Participants Experiencing Grade 2 or Higher Clinical AEs and LaboratoryAbnormalities in the Oral Phase and the Aggregate Oral and Injection Phases
Time frame: Measured through participant's first oral visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.
Proportion of Participants Receiving One or More Injections Who Experience Grade 2 or Higher Clinical AEs and Laboratory Abnormalities From Initial Injection to 36 Weeks Later.
Time frame: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.
Proportion of Injection Visits That Occurred "On-time".
Time frame: Measured through participant's last step 2 injection.
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period
Time frame: Measured through participant's first oral visit up to last Step 2 injection visit.
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period
Time frame: Measured through participant's first oral visit up to the last Step 2 injection visit.
Evaluate Rates of HIV Drug Resistance Among Participants Who Acquire HIV Infection During the Study
Time frame: Measured through participant's last study visit, up to approximately 1.5 years after study entry.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sybil Hosek, PhD study chair
Stroger Hospital of Cook County
Lynda Stranix-Chibanda, MBChB, MMED study chair
University of Zimbabwe College of Health Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabotegravir (CAB) tablet, CAB LA and Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites 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 13 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 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 Jan 2025). 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?
Safety Endpoint: Proportion of Participants Experiencing Any Grade 2 or Higher Clinical Adverse Events (AEs) and Laboratory Abnormalities Among Participants Who Receive at Least One Injection of CAB LA. (time frame: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.