Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DOH-27-082021-8379 | Other Identifier | South African National Clinical Trials Registry |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goals of this clinical study are to learn more about the study drugs, VRC07-523LS, CAP256V2LS, and vesatolimod (VES) and how safe it is in women that have HIV and are on antiretroviral therapy (ART).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VRC07523LS + CAP256V2LS + Vesatolimod (VES) | Experimental | In Period 1 (Days 0-28), participants will receive ART through Period. On Days 0 & 14, participants will be administered VES 6mg orally and on Day 28, participants will be administered VES either 6 or 8mg orally. VRC07-523LS & CAP256V2LS 20mg/kg will be administered intravenously on Day 7. In Period 2 (Days 29-133 or until ART restart), participants will discontinue ART at Day 35 and remain off ART until reaching ART restart criteria. Participants will receive VES 6 or 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA is >=5000 copies/mL. In Period 3, (Days 134-336 or until ART restart), participants will continue ATI and no study treatment will be administered. In Period 4, (Days 337-413) participants who have not met ART restart criteria by Day 337 may choose to restart ART (Period 4a) or may choose to continue ATI until end of study (Period 4B). Any participants who meet ART restart criteria before the end of the study will remain in follow-up on ART (Period 4A). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vesatolimod | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAE was defined as any AE that began on or after the study drug start date and no later than last exposure date after permanent discontinuation of study drug, or led to premature study drug discontinuation. | Up to 61.1 weeks |
| Percentage of Participants Experiencing Treatment-emergent Graded Laboratory Abnormalities | A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the last exposure date after permanent discontinuation of study drug. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. The severity grades were defined by Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, Antiviral Toxicity Grading Scale, Version 01 April 2015. The CTCAE v5 grading scale was used to grade AEs determined to be cytokine release syndrome and infusion-related reactions. The grading for both scales are as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening, Grade 5 = Death. | Up to 61.1 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Viral Rebound (Confirmed ≥ 50 Copies/mL and ≥ 200 Copies/mL) Following ATI | Virologic rebound is defined as at any visit a rebound in HIV-1 RNA to ≥ 50 copies/mL or ≥ 200 copies/mL, which is subsequently confirmed at the following scheduled or unscheduled visit. Time to rebound (in weeks) = (date of rebound or censoring date - ATI start date + 1) / 7. | Up to 56 weeks |
Not provided
Key Inclusion Criteria:
Age ≥ 18 years
Females recruited from the Females Rising through Education, Support, and Health (FRESH) acute human immunodeficiency virus (HIV) infection cohort.
Plasma human immunodeficiency -1 (HIV-1) ribonucleic acid (RNA) levels < 50 copies/mL at the screening visit.
On antiretroviral (ART) regimen for ≥ 12 consecutive months prior to the screening visit.
Have all the following laboratory values at the screening visit:
Women of childbearing potential to have documentation of agreement to follow study contraceptive requirements.
Documented plasma HIV-1 RNA < 50 copies/mL for 12 consecutive months prior to the screening visit.
In the judgment of the investigator, be in good general health.
Documented history of viral sensitivity to VRC07-523LS or CAP256V2LS at the screening visit.
Key Exclusion Criteria:
Have poor venous access that limits phlebotomy.
Positive serum pregnancy test.
Nursing participants.
Females with coinfection and/or immunosuppression as described below:
Have current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance or individual's safety.
Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or are expected to receive these agents during the study.
Have previous or current receipt of humanized or human monoclonal antibody (mAbs), or polyclonal immunoglobulin.
Have previous history of an antidrug antibodies response to a therapeutic agent.
Have previous receipt of an HIV vaccine.
Received any vaccine or immunomodulatory medication within 4 weeks prior to screening.
Have a history of any of the following:
Have current Class C acquired immunodeficiency syndrome (AIDS)-defining condition.
Have any serious or active medical or psychiatric illness that would interfere with participants treatment, assessment, or compliance with the protocol.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FRESH Clinical Research Site: Females Rising through Education, Support and Health | Umlazi | 4066 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Dong K, Asari V, Govender V, et al. Evaluation of 2 bNAbs plus vesatolimod in early-treated South African women with HIV-1 during ATI [CROI abstract 105]. Top Antivir Med. 2025;33:14 | ||
| Background | Omange RW, Zhang L, Reddy K, et al. Presence of protective human leukocyte antigen class I and II is associated with improved analytical treatment interruption outcomes in a trial of vesatolimod and broadly neutralizing antibodies in South African women with early-treated clade C HIV-1. Presented at the Keystone HIV Cure: Antiretroviral Therapy-Free Control of HIV Infection Symposium; April 7-10, 2025; Durban, South Africa. Poster 2014. | ||
| Background | Dong K, SenGupta D, Gama L, et al. First HIV cure interventional trial in Africa with collaboration between academia, government, and industry. Presented at the 13th International AIDS Society (IAS) Conference on HIV Science; July 13-17, 2025; Kigali, Rwanda. ePoster EP1003. | ||
| Background | Cai Y, Zhang L, Omange RW, et al. Vesatolimod pharmacodynamic responses in a trial of vesatolimod and broadly neutralizing antibodies in early-treated South African women with clade C HIV-1. Presented at the 13th International AIDS Society (IAS) Conference on HIV Science; July 13-17, 2025; Kigali, Rwanda. Poster WEPEB018. | ||
| 41685863 |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
26 participants were screened.
Participants were enrolled at a study site in South Africa.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | VRC07-523LS + CAP256V2LS + Vesatolimod (VES) | In Period 1 (Days 0 to 28), participants received antiretroviral therapy (ART) through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg & CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) was >=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued analytical treatment interruption (ATI) and no study treatment was administered. In Period 4, (Days 337-413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VRC07-523LS + CAP256V2LS + Vesatolimod (VES) | In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg & CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was >=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | An AE is any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAE was defined as any AE that began on or after the study drug start date and no later than last exposure date after permanent discontinuation of study drug, or led to premature study drug discontinuation. | The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to 61.1 weeks |
|
All-Cause Mortality and Adverse Events: Up to 61.1 weeks
All-Cause Mortality: The Enrolled Analysis Set included all participants who were enrolled into the study.
Adverse Events: The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VRC07-523LS + CAP256V2LS + VES | In Period 1 (Days 0 to 28), participants received ART through Period. On Days 0 and 14, participants were administered VES 6mg orally and on Day 28, participants were administered VES either 6mg or 8mg orally. VRC07-523LS 20mg/kg & CAP256V2LS 20mg/kg were administered intravenously on Day 7. In Period 2 (Days 29 to 133 or until ART restart), participants discontinued ART at Day 35 and remained off ART until reaching ART restart criteria. Participants received VES 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA was >=5000 copies/mL. In Period 3, (Days 134 to 336 or until ART restart), participants continued ATI and no study treatment was administered. In Period 4, (Days 337 to 413) participants who had not met ART restart criteria by Day 337 either choose to restart ART (Period 4a) or choose to continue ATI until end of study (Period 4B). Any participants who met ART restart criteria before the end of the study remained in follow-up on ART (Period 4A). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2022 | Dec 22, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2025 | Dec 9, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C582524 | vesatolimod |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| VRC07523LS | Biological | Administered intravenously |
|
| CAP256V2LS | Biological | Administered intravenously |
|
| Change in Plasma Viral Load Set-point Following ATI | Change in plasma viral load set-point between pre-ART value and prior to ART reinitiation following ATI was summarized. The pre-ART set point value is the HIV-RNA load count prior to start of initial ARV treatment recorded in the clinical database. | Pre-ART (Screening) and prior to ART reinitiation following ATI (Up to 56 weeks) |
| Change From Baseline of Viral Load at the End of ATI | Baseline value was the last available value collected on or prior to first dose of study drug. | Up to 48 weeks |
| Time to ART Resumption Following ATI | Time to ART resumption (in weeks) = (date of restart ART after ATI period start or censoring date - ATI start date + 1) / 7. | Up to 56 weeks |
| Pharmacokinetic (PK) Parameter of VES: Cmax | Cmax is defined as maximum observed concentration of drug. | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
| PK Parameter of VES: Tmax | Tmax is defined as time (observed time point) of Cmax. | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
| PK Parameter of VES: Clast | Clast is defined as last observed quantifiable concentration of the drug. | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
| PK Parameter of VES: Tlast | Tlast is defined as time (observed time point) of Clast. | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
| PK Parameter of VES: AUCinf | AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz). | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
| PK Parameter of VES: AUClast | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
| PK Parameter of VES: AUCexp | AUCexp is defined as AUC extrapolated between AUClast and AUCinf. | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
| PK Parameter of VES: t1/2 | t1/2 is defined as estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 2 by the terminal elimination rate constant (λz). | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
| PK Parameter of VES: CL/F | CL/F is defined as apparent clearance following extravascular administration. | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
| PK Parameter of VES: Vz/F | Vz/F is defined as apparent volume of distribution during the terminal phase following extravascular administration. | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
| PK Parameter of VRC07-523LS: Cmax | Cmax is defined as maximum observed concentration of drug. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of VRC07-523LS: Tmax | Tmax is defined as time (observed time point) of Cmax. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of VRC07-523LS: Clast | Clast is defined as last observed quantifiable concentration of the drug. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of VRC07-523LS: Tlast | Tlast is defined as time (observed time point) of Clast. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of VRC07-523LS: AUCinf | AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz). | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of VRC07-523LS: AUClast | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of VRC07-523LS: AUCexp | AUCexp is defined as AUC extrapolated between AUClast and AUCinf. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of VRC07-523LS: t1/2 | t1/2 is defined as estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 2 by the terminal elimination rate constant (λz). | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of VRC07-523LS: Clearance (CL) | CL is defined as clearance following intravenous administration. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of VRC07-523LS: Vss | Vss is defined as the volume of distribution at steady-state following intravenous administration. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of VRC07-523LS: Vz | Vz is defined as volume of distribution of the drug during the terminal phase after intravenous administration. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of CAP256V2LS: Cmax | Cmax is defined as maximum observed concentration of drug. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of CAP256V2LS: Tmax | Tmax is defined as time (observed time point) of Cmax. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of CAP256V2LS: Clast | Clast is defined as last observed quantifiable concentration of the drug. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of CAP256V2LS: Tlast | Tlast is defined as time (observed time point) of Clast. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of CAP256V2LS: AUCinf | AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz). | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of CAP256V2LS: AUClast | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of CAP256V2LS: AUCexp | AUCexp is defined as AUC extrapolated between AUClast and AUCinf. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of CAP256V2LS: t1/2 | t1/2 is defined as estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 2 by the terminal elimination rate constant (λz). | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of CAP256V2LS: CL | CL is defined as clearance following intravenous administration. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of CAP256V2LS: Vz | Vz is defined as volume of distribution of the drug during the terminal phase after intravenous administration. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| PK Parameter of CAP256V2LS: Vss | Vss is defined as the volume of distribution at steady-state after intravenous administration. | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
| Percentage of Participants With Treatment-emergent Positive Anti-VRC07-523LS Antibodies | Prebaseline (Day -13) up to Day 413 |
| Percentage of Participants With Treatment-emergent Positive Anti-CAP256V2LS Antibodies | Prebaseline (Day -13) up to Day 413 |
| Derived |
| Ahmed A, Hill M, Dong KL, Ngcobo MW, Zulu A, Langa N, Maphalala L, Pillay V, Mthembu M, Tran W, Lau R, Stockman JK, Ndung'u T, Dube K. Stress and Coping During an HIV Cure-Related Trial with an Analytical Treatment Interruption: A Qualitative Assessment of the Experiences of Young Women in Durban, South Africa. J Int Assoc Provid AIDS Care. 2026 Jan-Dec;25:23259582261423985. doi: 10.1177/23259582261423985. Epub 2026 Feb 13. |
| 41449969 | Derived | Ahmed A, Dong KL, Hussain M, Ngcobo MW, Langa N, Zulu A, Maphalala L, Pillay V, Mthembu M, Wan F, Tran W, Lau R, Stockman JK, Ndung'u T, Dube K. Psychological Impact of Analytical Treatment Interruption on Young Women Enrolled in an HIV Cure-Related Clinical Trial in Durban, South Africa. AIDS Res Hum Retroviruses. 2026 Mar;42(3):109-116. doi: 10.1177/08892229251405807. Epub 2026 Jan 2. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Percentage of Participants Experiencing Treatment-emergent Graded Laboratory Abnormalities | A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the last exposure date after permanent discontinuation of study drug. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. The severity grades were defined by Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, Antiviral Toxicity Grading Scale, Version 01 April 2015. The CTCAE v5 grading scale was used to grade AEs determined to be cytokine release syndrome and infusion-related reactions. The grading for both scales are as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening, Grade 5 = Death. | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | Up to 61.1 weeks |
|
|
|
| Secondary | Time to Viral Rebound (Confirmed ≥ 50 Copies/mL and ≥ 200 Copies/mL) Following ATI | Virologic rebound is defined as at any visit a rebound in HIV-1 RNA to ≥ 50 copies/mL or ≥ 200 copies/mL, which is subsequently confirmed at the following scheduled or unscheduled visit. Time to rebound (in weeks) = (date of rebound or censoring date - ATI start date + 1) / 7. | The Full Analysis Set included all participants who were enrolled into the study and had received at least 1 dose of study drug. | Posted | Median | Inter-Quartile Range | weeks | Up to 56 weeks |
|
|
|
| Secondary | Change in Plasma Viral Load Set-point Following ATI | Change in plasma viral load set-point between pre-ART value and prior to ART reinitiation following ATI was summarized. The pre-ART set point value is the HIV-RNA load count prior to start of initial ARV treatment recorded in the clinical database. | Participants in Full Analysis Set with available data were analyzed. | Posted | Median | Inter-Quartile Range | log10 copies/mL | Pre-ART (Screening) and prior to ART reinitiation following ATI (Up to 56 weeks) |
|
|
|
|
| Secondary | Change From Baseline of Viral Load at the End of ATI | Baseline value was the last available value collected on or prior to first dose of study drug. | Participants in Full Analysis Set were analyzed. | Posted | Median | Inter-Quartile Range | log10 copies/mL | Up to 48 weeks |
|
|
|
| Secondary | Time to ART Resumption Following ATI | Time to ART resumption (in weeks) = (date of restart ART after ATI period start or censoring date - ATI start date + 1) / 7. | Participants in full analysis set were analyzed. | Posted | Median | Inter-Quartile Range | weeks | Up to 56 weeks |
|
|
|
| Secondary | Pharmacokinetic (PK) Parameter of VES: Cmax | Cmax is defined as maximum observed concentration of drug. | The VES PK Analysis Set included all participants who were enrolled and had received at least 1 dose of VES and for whom PK concentrations of analyte VES were available. | Posted | Mean | Standard Deviation | pg/mL | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
|
|
|
| Secondary | PK Parameter of VES: Tmax | Tmax is defined as time (observed time point) of Cmax. | Participants in VES PK Analysis Set were analyzed. | Posted | Median | Full Range | hours (h) | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
|
|
|
| Secondary | PK Parameter of VES: Clast | Clast is defined as last observed quantifiable concentration of the drug. | Participants in VES PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | pg/mL | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
|
|
|
| Secondary | PK Parameter of VES: Tlast | Tlast is defined as time (observed time point) of Clast. | Participants in VES PK Analysis Set were anlayzed. | Posted | Median | Full Range | h | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
|
|
|
| Secondary | PK Parameter of VES: AUCinf | AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz). | Participants in VES analysis set were analyzed. | Posted | Mean | Standard Deviation | h*pg/mL | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
|
|
|
| Secondary | PK Parameter of VES: AUClast | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | Participants in VES analysis set were analyzed. | Posted | Mean | Standard Deviation | h*pg/mL | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
|
|
|
| Secondary | PK Parameter of VES: AUCexp | AUCexp is defined as AUC extrapolated between AUClast and AUCinf. | Participants in VES PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | percent | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
|
|
|
| Secondary | PK Parameter of VES: t1/2 | t1/2 is defined as estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 2 by the terminal elimination rate constant (λz). | Participants in VES PK Analysis Set were analyzed. | Posted | Median | Full Range | h | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
|
|
|
| Secondary | PK Parameter of VES: CL/F | CL/F is defined as apparent clearance following extravascular administration. | Participants in VES PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | Liters (L)/h | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
|
|
|
| Secondary | PK Parameter of VES: Vz/F | Vz/F is defined as apparent volume of distribution during the terminal phase following extravascular administration. | Participants with VES PK Analysis Set were analyzed. | Posted | Mean | Standard Deviation | L | Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose |
|
|
|
| Secondary | PK Parameter of VRC07-523LS: Cmax | Cmax is defined as maximum observed concentration of drug. | The VRC07-523LS PK Analysis Set included all participants who were enrolled and had received at least 1 dose of VRC07-523LS and for whom PK concentrations of analyte VRC07-523LS were available. Participants in VRC07-523LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | µg/mL | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of VRC07-523LS: Tmax | Tmax is defined as time (observed time point) of Cmax. | Participants in VRC07-523LS PK Analysis Set with available data were analyzed. | Posted | Median | Full Range | h | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of VRC07-523LS: Clast | Clast is defined as last observed quantifiable concentration of the drug. | Participants in VRC07-523LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | µg/mL | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of VRC07-523LS: Tlast | Tlast is defined as time (observed time point) of Clast. | Participants in VRC07-523LS PK Analysis Set with available data were analyzed. | Posted | Median | Full Range | day | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of VRC07-523LS: AUCinf | AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz). | Participants in VRC07-523LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | day*µg/mL | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of VRC07-523LS: AUClast | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | Participants in VRC07-523LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | day*µg/mL | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of VRC07-523LS: AUCexp | AUCexp is defined as AUC extrapolated between AUClast and AUCinf. | Participants in VRC07-523LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percent | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of VRC07-523LS: t1/2 | t1/2 is defined as estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 2 by the terminal elimination rate constant (λz). | Participants in VRC07-523LS PK Analysis Set with available data were analyzed. | Posted | Median | Full Range | day | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of VRC07-523LS: Clearance (CL) | CL is defined as clearance following intravenous administration. | Participants in VRC07-523LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | L/day | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of VRC07-523LS: Vss | Vss is defined as the volume of distribution at steady-state following intravenous administration. | Participants in VRC07-523LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | L | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of VRC07-523LS: Vz | Vz is defined as volume of distribution of the drug during the terminal phase after intravenous administration. | Participants in VRC07-523LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | L | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of CAP256V2LS: Cmax | Cmax is defined as maximum observed concentration of drug. | The CAP256V2LS PK Analysis Set included all participants who were enrolled and had received at least 1 dose of CAP256V2LS and for whom PK concentrations of analyte CAP256V2LS were available. Participants in CAP256V2LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | µg/mL | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of CAP256V2LS: Tmax | Tmax is defined as time (observed time point) of Cmax. | Participants in CAP256V2LS PK Analysis Set with available data were analyzed. | Posted | Median | Full Range | h | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of CAP256V2LS: Clast | Clast is defined as last observed quantifiable concentration of the drug. | Participants in CAP256V2LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | µg/mL | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of CAP256V2LS: Tlast | Tlast is defined as time (observed time point) of Clast. | Participants in CAP256V2LS PK Analysis Set with available data were analyzed. | Posted | Median | Full Range | day | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of CAP256V2LS: AUCinf | AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz). | Participants in CAP256V2LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | day*µg/mL | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of CAP256V2LS: AUClast | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | Participants in CAP256V2LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | day*µg/mL | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of CAP256V2LS: AUCexp | AUCexp is defined as AUC extrapolated between AUClast and AUCinf. | Participants in CAP256V2LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | percent | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of CAP256V2LS: t1/2 | t1/2 is defined as estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 2 by the terminal elimination rate constant (λz). | Participants in CAP256V2LS PK Analysis Set with available data were analyzed. | Posted | Median | Full Range | day | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of CAP256V2LS: CL | CL is defined as clearance following intravenous administration. | Participants in CAP256V2LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | L/day | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of CAP256V2LS: Vz | Vz is defined as volume of distribution of the drug during the terminal phase after intravenous administration. | Participants in CAP256V2LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | L | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | PK Parameter of CAP256V2LS: Vss | Vss is defined as the volume of distribution at steady-state after intravenous administration. | Participants in CAP256V2LS PK Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | L | Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413 |
|
|
|
| Secondary | Percentage of Participants With Treatment-emergent Positive Anti-VRC07-523LS Antibodies | The VRC07-523LS Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of VRC07-523LS and have had at least 1 nonmissing value for the immunogenicity evaluation of interest (ie, anti-VRC07-523LS antibody). | Posted | Number | percentage of participants | Prebaseline (Day -13) up to Day 413 |
|
|
|
| Secondary | Percentage of Participants With Treatment-emergent Positive Anti-CAP256V2LS Antibodies | The CAP256V2LS Immunogenicity Analysis Set included all enrolled participants who received at least 1 dose of CAP256V2LS and have had at least 1 nonmissing value for the immunogenicity evaluation of interest (ie, anti-CAP256V2LS antibody). | Posted | Number | percentage of participants | Prebaseline (Day -13) up to Day 413 |
|
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| 19 |
| 20 |
| Overdose | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Intentional self-injury | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 28.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 28.0 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Groin infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Latent syphilis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
|
| Genital swelling | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 28.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Measurements |
|---|---|
|
| Grade 3 |
|
| Grade 4 |
|