Trial Outcomes & Findings for Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 704/HPTN 085 AMP Study (NCT NCT04801758)
NCT ID: NCT04801758
Last Updated: 2025-04-20
Results Overview
From ART Re-Initiation Criteria form, calculated median and range of weeks of ATI meeting ART re-initiation criteria by HVTN 704/HPTN 085 treatment assignment. Note that participants with plasma ARV levels consistent with ongoing ARV use during ATI schedule are excluded
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Measured through participant's last visit on Schedule 1 or 2, up to 6 months.
Results posted on
2025-04-20
Participant Flow
Participant milestones
| Measure |
VRC01 10mg/kg
Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
VRC01 30mg/kg
Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
Placebo
Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72)
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
6
|
|
Overall Study
COMPLETED
|
7
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 704/HPTN 085 AMP Study
Baseline characteristics by cohort
| Measure |
VRC01 10mg/kg
n=7 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
VRC01 30mg/kg
n=5 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
Placebo
n=6 Participants
Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72)
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Region of Enrollment
Peru
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Age, Continuous
|
24 years
n=93 Participants
|
26 years
n=4 Participants
|
29 years
n=27 Participants
|
27 years
n=483 Participants
|
|
Age, Customized
18 - 20 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Customized
21 - 30 years
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Age, Customized
31 - 40 years
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Age, Customized
41 - 50 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Measured through participant's last visit on Schedule 1 or 2, up to 6 months.Population: Participants with plasma ARV levels consistent with ongoing ARV use during ATI schedule are excluded
From ART Re-Initiation Criteria form, calculated median and range of weeks of ATI meeting ART re-initiation criteria by HVTN 704/HPTN 085 treatment assignment. Note that participants with plasma ARV levels consistent with ongoing ARV use during ATI schedule are excluded
Outcome measures
| Measure |
VRC01 10mg/kg
n=7 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
VRC01 30mg/kg
n=4 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
Placebo
n=6 Participants
Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72)
|
|---|---|---|---|
|
Time to Meeting Criteria for ART Re-initiation
|
7.9 Weeks
Interval 4.6 to 20.4
|
8.9 Weeks
Interval 4.1 to 23.1
|
7.6 Weeks
Interval 2.7 to 17.9
|
PRIMARY outcome
Timeframe: Measured at week 24 of schedule 1- monitoring ATIPopulation: Participants with evidence of ARV use in ATI monitoring schedule are excluded from the analysis
From ART Re-Initiation Criteria form, counts number of participants with ≥ 24 weeks of ART without meeting ART re-initiation criteria by HVTN 704/HPTN 085 treatment assignment. Note that participants with evidence of ARV use in ATI monitoring schedule are excluded from the analysis
Outcome measures
| Measure |
VRC01 10mg/kg
n=7 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
VRC01 30mg/kg
n=4 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
Placebo
n=6 Participants
Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72)
|
|---|---|---|---|
|
Frequency of Sustained Post-treatment HIV Control, Defined as ≥ 24 Weeks Off ART Without Meeting ART Re-initiation Criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through participant's last study visit, up to 18 months.Population: Safety population
Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017
Outcome measures
| Measure |
VRC01 10mg/kg
n=7 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
VRC01 30mg/kg
n=5 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
Placebo
n=6 Participants
Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72)
|
|---|---|---|---|
|
Percentage of Participants Who Experience Adverse Events (AEs)
|
7 Participants
|
5 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Measured through participant's last study visit, up to 18 months.Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply).
Outcome measures
| Measure |
VRC01 10mg/kg
n=7 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
VRC01 30mg/kg
n=5 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
Placebo
n=6 Participants
Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72)
|
|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Measured through participant's last visit on Schedule 1 or 2, up to 6 monthsPopulation: Note that 1. participants with plasma ARV levels consistent with ongoing ARV use during ATI schedule are excluded; 2. Participants may meet more than one ART re-initiation criterion.
Tabulated by reason and HVTN 704/HPTN 085 treatment group. Note that 1. Participants with plasma ARV levels consistent with ongoing ARV use during ATI schedule are excluded; 2. Participants may meet more than one ART re-initiation criterion.
Outcome measures
| Measure |
VRC01 10mg/kg
n=7 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
VRC01 30mg/kg
n=4 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
Placebo
n=6 Participants
Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72)
|
|---|---|---|---|
|
Number of Participants Who Discontinue ATI
Discontinuation of ATI due to CD4+ T-Cell Count
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Discontinue ATI
Discontinuation of ATI due to HIV-Related Syndrome
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Discontinue ATI
Discontinuation of ATI due to Participant Request
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Discontinue ATI
Discontinuation of ATI due to Primary HIV Care Provider Request
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Discontinue ATI
Discontinuation of ATI due to CRS Clinician Decision
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Discontinue ATI
Discontinuation of ATI due to Viral Load
|
6 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Who Discontinue ATI
Discontinuation of ATI due to Pregnancy or Breastfeeding
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Discontinue ATI
Discontinuation of ATI due to Other AE
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through participant's last study visit, up to 18 monthsPopulation: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), Estimated Glomerular Filtration Rate (eFGR), Absolute Neutrophil Count, Direct Bilirubin, Hemoglobin, Platelets was summarized by arm. Only measurements with at least 1 record of grade 2 AE or above were shown in the table.
Outcome measures
| Measure |
VRC01 10mg/kg
n=7 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
VRC01 30mg/kg
n=5 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
Placebo
n=6 Participants
Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72)
|
|---|---|---|---|
|
Number of Local Laboratory Values Meeting Grade 2 AE Criteria or Above
Estimated Glomerular Filtration Rate (mL/min/1.73 m2)
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Local Laboratory Values Meeting Grade 2 AE Criteria or Above
Alanine Aminotransferase (U/L)
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured for participants undergoing ATI up at week 8, 16, and 24Population: Participants with plasma ARV levels consistent with ongoing ARV use during ATI schedule are excluded
The number (percentage) of participants with first viral load \>= 200 by Schedule 1 week 8, 16, and 24. Participants with plasma ARV levels consistent with ongoing ARV use during ATI schedule are excluded
Outcome measures
| Measure |
VRC01 10mg/kg
n=11 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
VRC01 30mg/kg
n=6 Participants
Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
Placebo
Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72)
|
|---|---|---|---|
|
Cumulative Incidence of Participants With First Viral Load ≥ 200 Copies/mL at Week 8, 16, and 24 of Schedule 1: Monitoring ATI
Week 8
|
8 Participants
|
4 Participants
|
—
|
|
Cumulative Incidence of Participants With First Viral Load ≥ 200 Copies/mL at Week 8, 16, and 24 of Schedule 1: Monitoring ATI
Week 16
|
9 Participants
|
4 Participants
|
—
|
|
Cumulative Incidence of Participants With First Viral Load ≥ 200 Copies/mL at Week 8, 16, and 24 of Schedule 1: Monitoring ATI
Week 24
|
9 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Measured through participant's last study visit, on average 15 monthsMeasured by flow cytometry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through participant's last study visit, on average 15 monthsMeasured by flow cytometry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through participant's last study visit, on average 15 monthsMeasured by flow cytometry
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through participant's last study visit, on average 15 monthsMeasured by TZM-bl neutralization assay
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through participant's last study visit, on average 15 monthsMeasured by ADCC, ADCP, and virion capture
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through participant's last study visit, on average 15 monthsMeasured by flow cytometry or other cell phenotyping assays
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through participant's last study visit, on average 15 monthsMeasured by flow cytometry or other cell phenotyping assays
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured through participant's last study visit, on average 15 monthsMeasured by Intact Proviral DNA Assay (IPDA), Tat/rev Induced Limiting Dilution Assay (TILDA), assays detecting replication-competent virus-bearing cells, and/or measures of total proviral DNA. Cell-associated HIV-RNA may be quantitated as a measure of the transcriptionally active reservoir.
Outcome measures
Outcome data not reported
Adverse Events
VRC01 10mg/kg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
VRC01 30mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VRC01 10mg/kg
n=7 participants at risk
Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
VRC01 30mg/kg
n=5 participants at risk
Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
Placebo
n=6 participants at risk
Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72)
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
Other adverse events
| Measure |
VRC01 10mg/kg
n=7 participants at risk
Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
VRC01 30mg/kg
n=5 participants at risk
Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72)
|
Placebo
n=6 participants at risk
Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72)
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
28.6%
2/7 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Gastrointestinal disorders
Haemorrhoids
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
General disorders
Fatigue
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
20.0%
1/5 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Acute HIV infection
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
20.0%
1/5 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Acute hepatitis C
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Anal chlamydia infection
|
57.1%
4/7 • Number of events 7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
80.0%
4/5 • Number of events 7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
50.0%
3/6 • Number of events 6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Furuncle
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
20.0%
1/5 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Influenza
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Latent syphilis
|
57.1%
4/7 • Number of events 7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
60.0%
3/5 • Number of events 5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Monkeypox
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
50.0%
3/6 • Number of events 4 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Oral herpes
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
42.9%
3/7 • Number of events 4 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
100.0%
5/5 • Number of events 6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
33.3%
2/6 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Parasitic gastroenteritis
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
20.0%
1/5 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Pharyngeal chlamydia infection
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Pharyngitis
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
40.0%
2/5 • Number of events 3 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Primary syphilis
|
14.3%
1/7 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
20.0%
1/5 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
33.3%
2/6 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Proctitis gonococcal
|
57.1%
4/7 • Number of events 4 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
40.0%
2/5 • Number of events 3 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
33.3%
2/6 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Respiratory tract infection
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Secondary syphilis
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Urethritis
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Infections and infestations
Urethritis chlamydial
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
20.0%
1/5 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
14.3%
1/7 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Injury, poisoning and procedural complications
Limb injury
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Investigations
Alanine aminotransferase increased
|
28.6%
2/7 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Investigations
Blood creatinine increased
|
28.6%
2/7 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Investigations
CD4 lymphocytes decreased
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Investigations
Creatinine renal clearance decreased
|
42.9%
3/7 • Number of events 4 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
20.0%
1/5 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
33.3%
2/6 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Investigations
Glomerular filtration rate decreased
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
20.0%
1/5 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Psychiatric disorders
Depression
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
40.0%
2/5 • Number of events 2 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Reproductive system and breast disorders
Balanoposthitis
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
20.0%
1/5 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/7 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
16.7%
1/6 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
14.3%
1/7 • Number of events 1 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/5 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
0.00%
0/6 • The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place