Trial Outcomes & Findings for Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males (NCT NCT04692077)

NCT ID: NCT04692077

Last Updated: 2025-05-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.

Results posted on

2025-05-20

Participant Flow

The study will be targeted towards at-risk, sexually active adolescent populations of MSM in the US. Enrollment will occur over approximately 18 months.

A total of 9 participants were eligible and enrolled. The Study has 3 steps, Oral CAB, Injection CAB LA and the Follow-up of Injection CAB with use of TDF/FTC, Truvada® for daily use or continued CAB injections for 48 weeks. One participant terminated before the end of Step 2 "Withdrawal by Subject". Of the 8 remaining participants, one participant "Scheduled exit visit/end of study" prior to the start of Step 3. Within Step 3, one participant switched from TDF/FTC to Injection CAB LA.

Participant milestones

Participant milestones
Measure	Cabotegravir Long Acting 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. Cabotegravir (CAB) tablet: 30 mg tablets CAB LA: 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) tablet: 300 mg/200 mg fixed-dose combination tablets
Cabotegravir Long Acting Oral Phase STARTED	9
Cabotegravir Long Acting Oral Phase COMPLETED	9
Cabotegravir Long Acting Oral Phase NOT COMPLETED	0
Cabotegravir Long Acting Injection Phase STARTED	9
Cabotegravir Long Acting Injection Phase COMPLETED	8
Cabotegravir Long Acting Injection Phase NOT COMPLETED	1
Step 3 Follow-up Phase STARTED	8
Step 3 Follow-up Phase CAB LA Injection	5
Step 3 Follow-up Phase Tenofovir/Emtricitabine	3
Step 3 Follow-up Phase COMPLETED	8
Step 3 Follow-up Phase NOT COMPLETED	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cabotegravir Long Acting 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. Cabotegravir (CAB) tablet: 30 mg tablets CAB LA: 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) tablet: 300 mg/200 mg fixed-dose combination tablets
Cabotegravir Long Acting Injection Phase Withdrawal by Subject	1

Baseline Characteristics

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cabotegravir Long Acting n=9 Participants 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. Cabotegravir (CAB) tablet: 30 mg tablets CAB LA: 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) tablet: 300 mg/200 mg fixed-dose combination tablets
Age, Continuous	16.4 years STANDARD_DEVIATION 0.7 • n=5 Participants
Age, Customized 12-15 years old	1 Participants n=5 Participants
Age, Customized 16-17 years old	8 Participants n=5 Participants
Sex/Gender, Customized Female	1 Participants n=5 Participants
Sex/Gender, Customized Gender Nonconforming/Gender Variant	1 Participants n=5 Participants
Sex/Gender, Customized Male	6 Participants n=5 Participants
Sex/Gender, Customized Self-Identify	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Age Standardized BMI z-score Classification Obese	2 Participants n=5 Participants
Age Standardized BMI z-score Classification Overweight	1 Participants n=5 Participants
Age Standardized BMI z-score Classification Normal	6 Participants n=5 Participants
Age Standardized BMI z-score Classification Thinness	0 Participants n=5 Participants
Age Standardized BMI z-score Classification Severe thinness	0 Participants n=5 Participants
Do you have a regular place or home where you stay and store your things? Yes	9 Participants n=5 Participants
Do you have a regular place or home where you stay and store your things? No	0 Participants n=5 Participants
In the past 6 months, how frequently did you worry that your household would not have enough food? Never worried	8 Participants n=5 Participants
In the past 6 months, how frequently did you worry that your household would not have enough food? Sometimes worried	0 Participants n=5 Participants
In the past 6 months, how frequently did you worry that your household would not have enough food? Often worried	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.

Population: Includes enrolled participants who receive at least one injection of CAB LA.

Outcome measures

Outcome measures
Measure	Cabotegravir Long Acting n=9 Participants Injectable cabotegravir 3 mL (600 mg) intramuscular (IM) injection
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.	8 Participants

PRIMARY outcome

Timeframe: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.

Population: Includes all enrolled participants

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

Outcome measures

Outcome measures
Measure	Cabotegravir Long Acting n=9 Participants Injectable cabotegravir 3 mL (600 mg) intramuscular (IM) injection
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 of participants who received at least 1 injection of CAB LA	9 Participants
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 of participants who reported any injection site reaction (ISR)	5 Participants
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 of participants who have reported any Grade 2 (moderate) or above ISR	3 Participants
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. Participants who Discontinued Early due to Intolerability of Injection or Burden of Study Procedure	1 Participants
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 of participants who completed all scheduled injections	8 Participants

PRIMARY outcome

Timeframe: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.

Population: Includes all enrolled participants and all enrolled participants who receive at least one injection of CAB LA.

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

Outcome measures

Outcome measures
Measure	Cabotegravir Long Acting n=9 Participants Injectable cabotegravir 3 mL (600 mg) intramuscular (IM) injection
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. Participant who received at least one injection among all enrolled participants	9 Participants
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. Participants with acceptability endpoint at the end of Step 2	6 Participants
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. Participants who received at least one injection and preferred injectable PrEP at the end of Step 2	4 Participants
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. If you wanted to protect yourself from HIV: Prefer not using a product	0 Participants
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. If you wanted to protect yourself from HIV: Condoms only	1 Participants
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. If you wanted to protect yourself from HIV: Oral PrEP pills only	0 Participants
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. If you wanted to protect yourself from HIV: Injectable PrEP only	0 Participants
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. If you wanted to protect yourself from HIV: Condoms and oral PrEP pills together	1 Participants
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. If you wanted to protect yourself from HIV: Condoms and injectable PrEP together	4 Participants
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. If you wanted to protect yourself from HIV: Prefer not to answer	0 Participants

SECONDARY outcome

Timeframe: Measured from the participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41

Population: Includes enrolled participants who receive at least one injection of CAB LA.

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.

Outcome measures

Outcome measures
Measure	Cabotegravir Long Acting n=9 Participants Injectable cabotegravir 3 mL (600 mg) intramuscular (IM) injection
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 1 · <1x PA-IC90	1 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 1 · >=1x - <4x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 1 · >=4x - <8x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 1 · >=8x PA-IC90	8 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 2 · <1x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 2 · >=1x - <4x PA-IC90	1 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 2 · >=4x - <8x PA-IC90	2 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 2 · >=8x PA-IC90	6 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 3 · <1x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 3 · >=1x - <4x PA-IC90	1 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 3 · >=4x - <8x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 3 · >=8x PA-IC90	7 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 4 · <1x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 4 · >=1x - <4x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 4 · >=4x - <8x PA-IC90	2 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 4 · >=8x PA-IC90	6 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 5 · <1x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 5 · >=1x - <4x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 5 · >=4x - <8x PA-IC90	1 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Injection 5 · >=8x PA-IC90	6 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Step 3 +8 weeks · <1x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Step 3 +8 weeks · >=1x - <4x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Step 3 +8 weeks · >=4x - <8x PA-IC90	0 Participants
Count of Participant-study Visits Above the Protein-adjusted Inhibitor Concentration (90%; PA-IC90) Step 3 +8 weeks · >=8x PA-IC90	7 Participants

SECONDARY outcome

Timeframe: Measured through seroconverter's first Oral visit up through end of study participation (step1, 2, 3)

Population: All enrolled participants who became HIV infected during the study (Step 1, 2 or 3). Serum concentrations were not collected for this measure because no participants had HPTN Laboratory Center (LC) Confirmed HIV Infection at enrollment or during Steps 1,2, and 3.

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured through participant's first oral visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.

Population: Includes enrolled participants who began step 1 (oral phase).

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)

Outcome measures

Outcome measures
Measure	Cabotegravir Long Acting n=9 Participants Injectable cabotegravir 3 mL (600 mg) intramuscular (IM) injection
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 of participants with Grade 2 or Higher AEs in Oral Phase	3 Participants
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 of participants with Grade 2 or Higher AEs in Oral and Injection Phase	8 Participants

SECONDARY outcome

Timeframe: Measured through participant's first injection visit up to 8 weeks after the last Step 2 injection visit or Week 41, whichever comes first.

Population: Includes enrolled 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 from the first injection visit to approximately 36 weeks later regardless of whether participants received all 5 injections.

Outcome measures

Outcome measures
Measure	Cabotegravir Long Acting n=9 Participants Injectable cabotegravir 3 mL (600 mg) intramuscular (IM) injection
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.	8 Participants

SECONDARY outcome

Timeframe: Measured through participant's last step 2 injection.

Population: Includes enrolled participants who receive at least one injection of CAB LA. By the end of step 2, just 1/8 participants missed their last injection but continued with the study and received a step 3 injection. This participant was counted as having 100% of injections completed with 5 injections. For this analysis, through the end of Step 2, technically 1 less injection was given in this case.

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.

Outcome measures

Outcome measures
Measure	Cabotegravir Long Acting n=41 Number of Injections Expected Injectable cabotegravir 3 mL (600 mg) intramuscular (IM) injection
Proportion of Injection Visits That Occurred "On-time". Number of injections given	40 Number of Injections given
Proportion of Injection Visits That Occurred "On-time". Number of injections given on-time	32 Number of Injections given

SECONDARY outcome

Timeframe: Measured through participant's first oral visit up to last Step 2 injection visit.

Population: Includes all enrolled participants: For each visits: analysis population includes participants with non-missing value. For the difference between 2 visits: analysis population only includes participants with non-missing values for both visits. .

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).

Outcome measures

Outcome measures
Measure	Cabotegravir Long Acting n=9 Participants Injectable cabotegravir 3 mL (600 mg) intramuscular (IM) injection
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Enrollment	0 Number of Sexual Partners Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 4	0 Number of Sexual Partners Standard Deviation 0.5
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 4: Change from previous visit	0 Number of Sexual Partners Standard Deviation 0.0
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 4: Change from baseline	0 Number of Sexual Partners Standard Deviation 0.0
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 5	0 Number of Sexual Partners Standard Deviation 0.7
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 5: Change from previous visit	0 Number of Sexual Partners Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 5: Change from baseline	0 Number of Sexual Partners Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 9	0 Number of Sexual Partners Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 9: Change from previous visit	0 Number of Sexual Partners Standard Deviation 0.7
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 9: Change from baseline	0 Number of Sexual Partners Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 17	0 Number of Sexual Partners Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 17: Change from previous visit	0 Number of Sexual Partners Standard Deviation 0.0
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 17: Change from baseline	0 Number of Sexual Partners Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 25	0 Number of Sexual Partners Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 25: Change from previous visit	0 Number of Sexual Partners Standard Deviation 0.0
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 25: Change from baseline	0 Number of Sexual Partners Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 33	0 Number of Sexual Partners Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 33: Change from previous visit	0 Number of Sexual Partners Standard Deviation 0.0
Change From Enrollment of Self-reported Sexual Behavior (Number of Sexual Partners) During the Study Period Week 33: Change from baseline	0 Number of Sexual Partners Standard Deviation 0.4

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Cabotegravir Long Acting n=9 Participants Injectable cabotegravir 3 mL (600 mg) intramuscular (IM) injection
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Enrollment	1 Episodes of condomless anal intercourse Standard Deviation 1.3
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 4	1 Episodes of condomless anal intercourse Standard Deviation 2.3
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 4: Change from previous visit	0 Episodes of condomless anal intercourse Standard Deviation 1.1
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 4: Change from baseline	0 Episodes of condomless anal intercourse Standard Deviation 1.1
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 5	0 Episodes of condomless anal intercourse Standard Deviation 0.7
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 5: Change from previous visit	-1 Episodes of condomless anal intercourse Standard Deviation 1.8
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 5: Change from baseline	0 Episodes of condomless anal intercourse Standard Deviation 0.7
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 9	0 Episodes of condomless anal intercourse Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 9: Change from previous visit	0 Episodes of condomless anal intercourse Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 9: Change from baseline	-1 Episodes of condomless anal intercourse Standard Deviation 1.1
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 17	0 Episodes of condomless anal intercourse Standard Deviation 1.1
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 17: Change from previous visit	0 Episodes of condomless anal intercourse Standard Deviation 0.8
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 17: Change from baseline	0 Episodes of condomless anal intercourse Standard Deviation 0.5
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 25	0 Episodes of condomless anal intercourse Standard Deviation 0.7
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 25: Change from previous visit	0 Episodes of condomless anal intercourse Standard Deviation 0.4
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 25: Change from baseline	0 Episodes of condomless anal intercourse Standard Deviation 0.7
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 33	0 Episodes of condomless anal intercourse Standard Deviation 0.0
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 33: Change from previous visit	0 Episodes of condomless anal intercourse Standard Deviation 0.8
Change From Enrollment of Self-reported Sexual Behavior (Number of Episodes of Anal Intercourse Without a Condom) During the Study Period Week 33: Change from baseline	-1 Episodes of condomless anal intercourse Standard Deviation 1.5

SECONDARY outcome

Timeframe: Measured through participant's last study visit, up to approximately 1.5 years after study entry.

Population: Includes all enrolled participants who seroconverted 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.

Outcome measures

Outcome measures
Measure	Cabotegravir Long Acting n=9 Participants Injectable cabotegravir 3 mL (600 mg) intramuscular (IM) injection
Evaluate Rates of HIV Drug Resistance Among Participants Who Acquire HIV Infection During the Study Number of participants HIV-positive at enrollment	0 Participants
Evaluate Rates of HIV Drug Resistance Among Participants Who Acquire HIV Infection During the Study Number of participants infected	0 Participants
Evaluate Rates of HIV Drug Resistance Among Participants Who Acquire HIV Infection During the Study Number of drug resistant cases	0 Participants

Adverse Events

Step 1 - CAB LA Oral Phase

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Step 2 - CAB LA Injection Phase

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Step 3 - CAB LA Injection Follow-up

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Step 3 - Tenofovir/Emtricitabine Follow-up

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Step 1 - CAB LA Oral Phase n=9 participants at risk A 5-week oral CAB 30 mg QD safety lead-in	Step 2 - CAB LA Injection Phase n=9 participants at risk A series of 5 intramuscular (IM) injections of 3 mL (600 mg) cabotegravir administered at 8 week intervals after a 4-week loading dose (injections at weeks 5, 9, 17, 25 \& 33)	Step 3 - CAB LA Injection Follow-up n=6 participants at risk Participants who elected to receive intramuscular (IM) cabotegravir (CAB LA) injections during Step 3 follow-up. This regimen consists of 3 mL (600 mg) injections administered every 8 weeks for up to 48 weeks after their final injection in Step 2, with injections given at weeks +8, +16, +24, +32, +40, and +48.	Step 3 - Tenofovir/Emtricitabine Follow-up n=3 participants at risk Participants who elected to receive daily oral Tenofovir/Emtricitabine (TDF/FTC, Truvada®) during Step 3 follow-up. This regimen consists of a 300 mg/200 mg tablet administered daily for up to 48 weeks after their final injection in Step 2, starting at the +8 week visit (then followed at weeks +12, +24, +36, and +48). Participants in Step 3 are permitted to switch from TDF/FTC to CAB LA if desired.
Psychiatric disorders Suicidal ideation	0.00% 0/9 • Measured from participant's first Oral visit up to follow-up 48 weeks Step 3. SAE, NON SAE, and Mortality are summarized by Steps (Oral, Injection \& Follow-up)	0.00% 0/9 • Measured from participant's first Oral visit up to follow-up 48 weeks Step 3. SAE, NON SAE, and Mortality are summarized by Steps (Oral, Injection \& Follow-up)	16.7% 1/6 • Number of events 1 • Measured from participant's first Oral visit up to follow-up 48 weeks Step 3. SAE, NON SAE, and Mortality are summarized by Steps (Oral, Injection \& Follow-up)	0.00% 0/3 • Measured from participant's first Oral visit up to follow-up 48 weeks Step 3. SAE, NON SAE, and Mortality are summarized by Steps (Oral, Injection \& Follow-up)

Other adverse events

Additional Information

HPTN Statistical Manager

HPTN Statistical & Data Management Center

Phone: +1 (206) 667-4004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place