Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 15 of 15

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Documented Incident HIV Infections During Steps 1 and 2	HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.	mITT Population (Steps 1 and 2): Participants who were inappropriately enrolled are excluded. Participants who were found by the EAC to be HIV infected at enrollment are excluded.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Experiencing Grade 2 or Higher Clinical and Laboratory Adverse Events	Treatment emergent AE* measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each visit (injections visits q 8 weeks and safety visits q 8 weeks).	Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Documented Incident HIV Infections in Step 2	HIV tests at enrollment, weeks 2, 4, 5, every injection visit (every 8 weeks) and every safety visit (2 weeks after each injection visit). Analyzed through week 153 or the date of DSMB decision to unblind all participants, whichever is earliest.	Injection step 2 efficacy: The subgroup of the mITT population who received at least one injection and had at least one HIV result assessed after the first injection visit.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Changes From Baseline in Creatinine and Creatinine Clearance Levels	Reported week 57 (injection visit #8) and week 105 (injection visit #14)	All subjects who received at least one dose of study product, and for whom have results for creatine and creatinine clearance at enrollment AND for at least one of the following two time points: Week 57 and Week 105.	umol/L	MEDIAN
SECONDARY	Number of Participants With Grade 3 or 4 Liver-related Adverse Events (AEs)	Treatment emergent AE measured with onset date through participant's last study visit, or the date of DSMB decision to unblind all participants, whichever is first. Assessed at each visit. (Injection visits q 8 weeks and safety visits q 8 weeks)	Inappropriately enrolled participants, participants with invalid ID due to duplicate screening or enrollment and participants who did not receive any oral study drug are excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Incidence of Resistance Mutations to Study Products (Including But Not Limited to K65R, M184V/I, Q148R) Among Seroconverters	Measured from date of detection of infection, up to 4 years after study entry, with timing/intervals as determined by the HPTN laboratory center	All participants in the mITT population who acquired HIV, including those who were found to have acquired HIV prior to randomization.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Changes in Weight From Baseline	Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Collected at each injection visit (every 8 weeks).	Enrolled participants with available data at each visit	Kg	MEDIAN
SECONDARY	Changes in Systolic Blood Pressure From Baseline	Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).	Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	mmHg	MEDIAN
SECONDARY	Changes in Diastolic Blood Pressure From Baseline	Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).	Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	mmHg	MEDIAN
SECONDARY	Changes in Pulse Rate From Baseline	Reported through the week 153 injection, or the date of DSMB decision to unblind all participants, whichever is earliest. Assessed at each injection visit (every 8 weeks).	Includes the subset of subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled.	beats/min	MEDIAN
SECONDARY	Changes in Fasting Glucose Levels From Baseline	Assessed at weeks 57 and 105.	Participants who were inappropriately enrolled are excluded. Inappropriately enrolled participants and participants with invalid ID due to duplicate screening or enrollment are excluded.	mg/dL	MEDIAN
SECONDARY	Changes in Fasting Lipid Profile From Baseline	Assessed at weeks 57 and 105.	Inappropriately enrolled participants and participants with invalid ID due to duplicate screening or enrollment are excluded.	mg/dL	MEDIAN
SECONDARY	Summary of Overall Satisfaction With Study Product	Assessed at Week 17, 41	All subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled, and for whom have results for satisfaction with study product at a given visit.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Summary of Preference Based on Satisfaction With Study Product	Assessed at week 17, 41	All subjects who received any study product, including those were subsequently deemed to be inappropriately enrolled, and for whom have results for preference based on satisfaction with study product at a given visit.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline of Mean Z-scores of Bone Mineral Density	Measured at enrollment, week 57 and week 105	DEXA-substudy participants who received at least 10 injections (active CAB or placebo) within 18 months of enrollment	Z-score	MEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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