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| ID | Type | Description | Link |
|---|---|---|---|
| 12002 | Registry Identifier | DAIDS-ES | |
| WRAIR 2166 | Other Identifier | NIAID |
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This study will evaluate the safety and virologic effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), alone or in combination with antiretroviral therapy (ART), in adults during early acute HIV infection.
Human monoclonal antibodies (mAbs) may have the potential to treat HIV infection by preventing the spread of the virus. This study will evaluate an experimental mAB known as VRC-HIVMAB060-00-AB (VRC01). The purpose of this study is to evaluate the safety and virologic effect of VRC01, alone or in combination with ART, in adults with early acute HIV infection. Researchers will also evaluate the effect of VRC01 on the establishment of an HIV reservoir during early acute HIV infection.
This study will enroll participants who are diagnosed with early acute HIV infection. Participants will be randomly assigned to one of three groups: Group 1 will begin ART and receive a single infusion of placebo at Day 0. Group 2 will begin ART and receive a single infusion of VRC01 at Day 0. Group 3 will receive a single infusion of VRC01 on Day 0 and begin ART on Day 7. ART will vary by country and will consist of country guideline-recommended, available first line combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
Study visits will occur at Days 0, 1, 3, 7, 10, 14, 18, 21, 25, 28, 42, 56, 84, 112, 168, and 175. Visits will include a physical examination, medical history review, and blood collection. Neurocognitive testing will take place on Day 168. Some participants may take part in optional study procedures at various time points during the study including mucosal secretion collection, rectosigmoid biopsy, lymph node biopsy, leukapheresis, and lumbar puncture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: immediate ART and placebo infusion | Experimental | Participants will start ART and will receive a single infusion of placebo at Day 0. |
|
| Group 2: immediate ART and VRC01 infusion | Experimental | Participants will start ART and receive a single infusion of VRC01 at Day 0. |
|
| Group 3: immediate VRC01 infusion and subsequent ART | Experimental | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VRC01 | Biological | 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 3 or Greater mAb-related Reactogenicity and mAb-related Adverse Events (AEs) | This outcome is the combined total number of grade 3 or higher mAb-related reactogenicity events and mAb-related adverse events for each group. Only grade 3 reactogenicity events/AEs that are determined by the study physicians to be related to mAb are included. Adverse events, including reactogenicity events, are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events v2.0 dated November 2014. This outcome is the total number of solicited adverse events (reactogenicity events) that had a severity of grade 3 or higher and were related to the mAb. Note that higher grades indicate worse severity. | Measured through Week 24 |
| Plasma Viral Load Change From Day 0 to Day 7 | Measured through Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Virologic Suppression (Less Than 50 Copies/ml) in Plasma | Measured through Week 24 | |
| Number of Total Viremic Copy Days (Area Under Viral Load Curve) From Day 0 to Week 24 | Measured through Week 24 |
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Inclusion Criteria:
Female-Specific Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LTC Julie Ake, MD | U.S. Military HIV Research Program (MHRP)/Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) | Study Chair |
| Merlin Robb, MD | US Military HIV Research Program | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya Med. Research Inst./Walter Reed Project, Clinical Research Centre, Off Hospital Road. Kericho | Kericho | 20200 | Kenya | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Immediate ART and Placebo Infusion | Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2018 |
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|
| Placebo for VRC01 | Biological | Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump |
|
| Antiretroviral therapy (ART) (regimen will vary within countries and by patient) | Drug | ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
|
| Measurement of Plasma Viremia Including Single Copy HIV RNA Quantification | In samples with HIV RNA less than 50 copies/ml at Day 7, Day 14, and Week 24 | Measured through Week 24 |
| Measurement of Cell-associated HIV RNA and DNA in the Peripheral Compartment | Measured through Week 24 (Day 168) |
| Percentage of Participants Experiencing Acute Retroviral Syndrome | Measured through Week 24 |
| Percentage of Participants Experiencing a Hospitalization | Measured through Week 24 |
| Percentage of Participants Experiencing Opportunistic Infections | Measured through Week 24 |
| Percentage of Participants Experiencing Non-AIDS-related Conditions | Measured through Week 24 |
| Measurement of CD4 + T Cells | Decrease from baseline to nadir, increase from nadir to Week 24, and overall change from baseline to Week 24 | Measured through Week 24 |
| Measurement of VRC01 Levels in Peripheral Blood | Measured through Week 24 |
| National Institute for Medical Research (NIMR)-Mbeya Medical Research Center (MMRC) Non-Network CRS |
| Mbeya |
| Tanzania |
| SEARCH Thai Red Cross AIDS Research Centre Non-Network CRS | Bangkok | 10330 | Thailand |
| ECHO Center Non-Network CRS | Chon Buri | Thailand |
| Makerere University Walter Reed Project (MUWRP) | Kampala | Uganda |
| FG001 | Group 2: Immediate ART and VRC01 Infusion | Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
| FG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Immediate ART and Placebo Infusion | Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
| BG001 | Group 2: Immediate ART and VRC01 Infusion | Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
| BG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline Viral Load | Mean | Standard Deviation | log10(copies/mL) |
| |||||||||||||||
| Baseline CD4+ Count | Mean | Standard Deviation | cells/microLiter |
| |||||||||||||||
| Fiebig Stage | Fiebig stages are: I) HIV RNA detectable, p24 antigen non-reactive, 3rd gen ELISA non-reactive; II) HIV RNA and p24 antigen detectable; 3rd gen ELISA non-reactive; III) HIV RNA and p24 antigen detectable; 3rd gen ELISA reactive, Western Blot negative; IV) HIV RNA and p24 antigen detectable; 3rd gen ELISA positive, Western Blot indeterminate; V) HIV RNA detectable, p24 antigen detectable or not detectable, 3rd gen ELISA reactive, Western Blot positive but lacking p31 band; VI) HIV RNA detectable, p24 antigen detectable or not detectable, 3rd gen ELISA reactive, Western Blot positive w/p31 band | Count of Participants | 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 | Number of Participants With Grade 3 or Greater mAb-related Reactogenicity and mAb-related Adverse Events (AEs) | This outcome is the combined total number of grade 3 or higher mAb-related reactogenicity events and mAb-related adverse events for each group. Only grade 3 reactogenicity events/AEs that are determined by the study physicians to be related to mAb are included. Adverse events, including reactogenicity events, are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events v2.0 dated November 2014. This outcome is the total number of solicited adverse events (reactogenicity events) that had a severity of grade 3 or higher and were related to the mAb. Note that higher grades indicate worse severity. | All randomized participants | Posted | Count of Participants | Participants | Measured through Week 24 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Plasma Viral Load Change From Day 0 to Day 7 | All randomized participants | Posted | Mean | Standard Deviation | log(copies/mL) | Measured through Day 7 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Time to Virologic Suppression (Less Than 50 Copies/ml) in Plasma | All randomized participants | Posted | Median | 95% Confidence Interval | Days | Measured through Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Total Viremic Copy Days (Area Under Viral Load Curve) From Day 0 to Week 24 | All randomized participants | Posted | Mean | 95% Confidence Interval | days | Measured through Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Measurement of Plasma Viremia Including Single Copy HIV RNA Quantification | In samples with HIV RNA less than 50 copies/ml at Day 7, Day 14, and Week 24 | Posted | Mean | 95% Confidence Interval | log-10(copies/mL) | Measured through Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Measurement of Cell-associated HIV RNA and DNA in the Peripheral Compartment | Virologic population consists of all randomized participants. | Posted | Mean | Standard Deviation | log10 copies/mL | Measured through Week 24 (Day 168) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Acute Retroviral Syndrome | Posted | Count of Participants | Participants | Measured through Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing a Hospitalization | Posted | Count of Participants | Participants | Measured through Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Opportunistic Infections | Posted | Count of Participants | Participants | Measured through Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Non-AIDS-related Conditions | Posted | Count of Participants | Participants | Measured through Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Measurement of CD4 + T Cells | Decrease from baseline to nadir, increase from nadir to Week 24, and overall change from baseline to Week 24 | Change is analyzed using participants with data at both time points. | Posted | Mean | 95% Confidence Interval | cells/microLiter | Measured through Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Measurement of VRC01 Levels in Peripheral Blood | The analysis population for this outcome is defined as those in the virologic population who have available samples for measuring the amount of VRC01 in the peripheral compartment. Some participants did not have samples available for the PK analysis. | Posted | Mean | Standard Deviation | ng/mL | Measured through Week 24 |
|
Adverse event data are collected through 175 days after study agent administration.
MedDRA version 21.2 was used. The site clinical research team will ascertain accurate recording of AEs on a daily basis. The clinical investigators will monitor and analyze study data as they become available and will make determinations regarding the severity of the adverse experiences and their relation to study product.
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 | Group 1: Immediate ART and Placebo Infusion | Participants will start ART and will receive a single infusion of placebo at Day 0. Placebo for VRC01: Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. | 0 | 8 | 2 | 8 | 8 | 8 |
| EG001 | Group 2: Immediate ART and VRC01 Infusion | Participants will start ART and receive a single infusion of VRC01 at Day 0. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. | 0 | 8 | 0 | 8 | 7 | 8 |
| EG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. | 0 | 8 | 1 | 8 | 7 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anal fistula repair | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anal pruritus | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anorectal ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oral mucosa haematoma | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urethritis gonococcal | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Anal fistula repair | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Rhinoplasty | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Glenna Schluck | Data Coordinating and Analysis Center, HJF Global Infectious Diseases | 3015003824 | gschluck@global-id.org |
| Apr 22, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C578595 | VRC01 monoclonal antibody |
Not provided
Not provided
Not provided
| Female |
|
| Transgender |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Uganda |
|
| Kenya |
|
| Thailand |
|
| Fiebig Stage 2 |
|
| Fiebig Stage 3 |
|
| Fiebig Stage 4 |
|
| Fiebig Stage 5 |
|
| OG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
|
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| OG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
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| OG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
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| OG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
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| OG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
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| OG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
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| OG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
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| OG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
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| OG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
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| OG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
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| OG002 | Group 3: Immediate VRC01 Infusion and Subsequent ART | Participants will receive a single infusion of VRC01 on Day 0 followed by ART initiation on Day 7. VRC01: 40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump Antiretroviral therapy (ART) (regimen will vary within countries and by patient): ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure. |
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