Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

List	Outcome	Time frame	Description
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.	All HIV infections included in this analysis have been reviewed and confirmed by an independent, blinded Endpoint Adjudication Committee (EAC).
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).	The primary safety endpoint analyses included Grade 2 or higher clinical and laboratory AEs during Steps 1 and 2.
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.	Evaluate incident HIV-1infections occurring only during Step 2, using the Injection Step 2 Efficacy population
Secondary	Changes From Baseline in Creatinine and Creatinine Clearance Levels	Reported week 57 (injection visit #8) and week 105 (injection visit #14)	Change from baseline at each visit is the difference between the creatine (and creatinine clearance) value as measured on the date of visit, compared to the value as measured at the enrollment visit.
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)	Laboratory assessment of alanine aminotransferase (ALT), aspartate aminotransferase (AST), TBili, creatine phosphokinase (CPK), or clinical assessment of jaundice/icterus.
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	Frequency of the detection of specific viral mutations known to confer resistance to specific classes of antiviral drugs as identified in specimens collected from infected participants during follow-up after HIV infection.
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).	Change in weight from baseline is the difference between the weight (kg) as collected at each study visit and the weight collected at the enrollment visit.
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).	Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.
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).	Change in blood pressure from baseline is the difference between the blood pressure as collected at each study visit and the blood pressure collected at the enrollment visit. Reported in separate tables for systole and diastole.
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).	Change in pulse rate from baseline is the difference between the pulse rate as collected at each study visit and the pulse rate collected at the enrollment visit.
Secondary	Changes in Fasting Glucose Levels From Baseline	Assessed at weeks 57 and 105.	Changes in fasting glucose levels from baseline at week 57 and week 105 based on laboratory evaluations.
Secondary	Changes in Fasting Lipid Profile From Baseline	Assessed at weeks 57 and 105.	Changes in fasting lipid profile from baseline at week 57 and week 105 based on laboratory evaluations.
Secondary	Summary of Overall Satisfaction With Study Product	Assessed at Week 17, 41	Summary of overall satisfaction with study product at Week 17 and Week 41. 0 represents None of the time and 6 represents All of the times for the questions 'How often is it inconvenient or difficult to receive oral study medication as recommended?' and 'How often do you find it inconvenient or difficult to receive your injection as recommended?', 0 represents None at all and 6 represent A very great deal for the questions 'How much pain or discomfort have you experienced with your oral study medication (tablets)?' and 'How much pain or discomfort have you experienced with your injection?'.
Secondary	Summary of Preference Based on Satisfaction With Study Product	Assessed at week 17, 41	Summary of preference based on satisfaction with study product at Week 17 and Week 41
Secondary	Change From Baseline of Mean Z-scores of Bone Mineral Density	Measured at enrollment, week 57 and week 105	Change from baseline of mean standard scores (Z-scores) to week 57 and week 105 in the bone mineral density (BMD) at femoral neck, lumbar spine, and total hip region were summarized using DEXA subset. BMD z-scores from Hologic instrument scans were standardized by race, age, and gender using the Hologic DXA Reference Data. Male reference values were used for men who have sex with men and female reference values for transgender women. A z-score of 0 represents the mean of the analysis population standardized by race, age, and gender. Higher z-scores in BMD indicate a better outcomes. A z-score of -2.0 or lower is generally considered below the expected range, potentially indicating secondary osteoporosis requiring further medical evaluation.

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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