National Institute of Allergy and Infectious Diseases (NIAID)
Who can join
Under 17, male only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.Primary· 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.
Group
Value
95% CI
Cabotegravir Long Acting
8
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.Primary· 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
Number of participants who received at least 1 injection of CAB LA
Group
Value
95% CI
Cabotegravir Long Acting
9
Number of participants who reported any injection site reaction (ISR)
Group
Value
95% CI
Cabotegravir Long Acting
5
Number of participants who have reported any Grade 2 (moderate) or above ISR
Group
Value
95% CI
Cabotegravir Long Acting
3
Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedure
Group
Value
95% CI
Cabotegravir Long Acting
1
Number of participants who completed all scheduled injections
Group
Value
95% CI
Cabotegravir Long Acting
8
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.Primary· 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
Participant who received at least one injection among all enrolled participants
Group
Value
95% CI
Cabotegravir Long Acting
9
Participants with acceptability endpoint at the end of Step 2
Group
Value
95% CI
Cabotegravir Long Acting
6
Participants who received at least one injection and preferred injectable PrEP at the end of Step 2
Group
Value
95% CI
Cabotegravir Long Acting
4
If you wanted to protect yourself from HIV: Prefer not using a product
Group
Value
95% CI
Cabotegravir Long Acting
0
If you wanted to protect yourself from HIV: Condoms only
Group
Value
95% CI
Cabotegravir Long Acting
1
If you wanted to protect yourself from HIV: Oral PrEP pills only
Group
Value
95% CI
Cabotegravir Long Acting
0
If you wanted to protect yourself from HIV: Injectable PrEP only
Group
Value
95% CI
Cabotegravir Long Acting
0
If you wanted to protect yourself from HIV: Condoms and oral PrEP pills together
Group
Value
95% CI
Cabotegravir Long Acting
1
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90)Secondary· Measured from the participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41
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 huma
Injection 1
Group
Value
95% CI
Cabotegravir Long Acting
1
Cabotegravir Long Acting
0
Cabotegravir Long Acting
0
Cabotegravir Long Acting
8
Injection 2
Group
Value
95% CI
Cabotegravir Long Acting
0
Cabotegravir Long Acting
1
Cabotegravir Long Acting
2
Cabotegravir Long Acting
6
Injection 3
Group
Value
95% CI
Cabotegravir Long Acting
0
Cabotegravir Long Acting
1
Cabotegravir Long Acting
0
Cabotegravir Long Acting
7
Injection 4
Group
Value
95% CI
Cabotegravir Long Acting
0
Cabotegravir Long Acting
0
Cabotegravir Long Acting
2
Cabotegravir Long Acting
6
Injection 5
Group
Value
95% CI
Cabotegravir Long Acting
0
Cabotegravir Long Acting
0
Cabotegravir Long Acting
1
Cabotegravir Long Acting
6
Step 3 +8 weeks
Group
Value
95% CI
Cabotegravir Long Acting
0
Cabotegravir Long Acting
0
Cabotegravir Long Acting
0
Cabotegravir Long Acting
7
Count and Percentage of Participants Experiencing Grade 2 or Higher Clinical AEs and LaboratoryAbnormalities in the Oral Phase and the Aggregate Oral and Injection PhasesSecondary· Measured through participant's first oral 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 from:
1. enrollment to week 5 (oral phase (step 1), including interim visits).
2. enrollment to 8 weeks following the last injection received (aggregate over oral + injection phases (step 1-step 2) including interim visits)
Number of participants with Grade 2 or Higher AEs in Oral Phase
Group
Value
95% CI
Cabotegravir Long Acting
3
Number of participants with Grade 2 or Higher AEs in Oral and Injection Phase
Group
Value
95% CI
Cabotegravir Long Acting
8
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.Secondary· 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 from the first injection visit to approximately 36 weeks later regardless of whether participants received all 5 injections.
Group
Value
95% CI
Cabotegravir Long Acting
8
Proportion of Injection Visits That Occurred "On-time".Secondary· Measured through participant's last step 2 injection.
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.
Number of injections given
Group
Value
95% CI
Cabotegravir Long Acting
40
Number of injections given on-time
Group
Value
95% CI
Cabotegravir Long Acting
32
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study PeriodSecondary· Measured through participant's first oral visit up to last Step 2 injection visit.
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).
Enrollment
Group
Value
95% CI
Cabotegravir Long Acting
0
± 0.4
Week 4
Group
Value
95% CI
Cabotegravir Long Acting
0
± 0.5
Week 4: Change from previous visit
Group
Value
95% CI
Cabotegravir Long Acting
0
± 0.0
Week 4: Change from baseline
Group
Value
95% CI
Cabotegravir Long Acting
0
± 0.0
Week 5
Group
Value
95% CI
Cabotegravir Long Acting
0
± 0.7
Week 5: Change from previous visit
Group
Value
95% CI
Cabotegravir Long Acting
0
± 0.4
Week 5: Change from baseline
Group
Value
95% CI
Cabotegravir Long Acting
0
± 0.4
Week 9
Group
Value
95% CI
Cabotegravir Long Acting
0
± 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study PeriodSecondary· Measured through participant's first oral visit up to the last Step 2 injection visit.
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).
Enrollment
Group
Value
95% CI
CAB LA
1
± 1.3
Week 4
Group
Value
95% CI
CAB LA
1
± 2.3
Week 4: Change from previous visit
Group
Value
95% CI
CAB LA
0
± 1.1
Week 4: Change from baseline
Group
Value
95% CI
CAB LA
0
± 1.1
Week 5
Group
Value
95% CI
CAB LA
0
± 0.7
Week 5: Change from previous visit
Group
Value
95% CI
CAB LA
-1
± 1.8
Week 5: Change from baseline
Group
Value
95% CI
CAB LA
0
± 0.7
Week 9
Group
Value
95% CI
CAB LA
0
± 0.4
Evaluate Rates of HIV Drug Resistance Among Participants Who Acquire HIV Infection During the StudySecondary· Measured through participant's last study visit, up to approximately 1.5 years after study entry.
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.
Number of participants HIV-positive at enrollment
Group
Value
95% CI
Cabotegravir Long Acting
0
Number of participants infected
Group
Value
95% CI
Cabotegravir Long Acting
0
Number of drug resistant cases
Group
Value
95% CI
Cabotegravir Long Acting
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Measured from participant's first Oral visit up to follow-up 48 weeks Step 3..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02951052 — Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpiv
· Phase 3
· active not recruiting
NCT02938520 — Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for M
· Phase 3
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 20 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04692077.