Phase
Condition
Hiv
Treatment
PGT121.414.LS 400mg
VRC07-523LS 400mg
PGDM1400LS 1600mg
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants need to be between 18 and 65 years old.
Participants must have access to a participating clinical research site and bewilling to follow the study schedule.
Participants should understand the study details and be willing to give informedconsent.
Participants must agree not to join any other clinical trials until they finish thisstudy.
Participants must be willing to receive HIV test results.
Participants should be open to discussing HIV prevention.
Clinic staff should assess participants as having a low risk of getting HIV, andparticipants must commit to avoiding high-risk behaviors during the study.
Hemoglobin: Participant meets minimum levels depending on gender and hormone therapystatus.
White Blood Cells (WBC): Should be within the normal range or approved by a siteclinician.
Platelets: At least 100,000 cells/mm³.
Alanine aminotransferase (ALT): Less than 5 times the upper normal limit.
Creatinine: Less than 1.8 times the upper normal limit or less than 1.5 times yourbaseline level.
Participants must test negative for HIV-1 and HIV-2.
Participants urine protein must be negative or trace.
Reproductive Status:
Participants of child-bearing potential need a negative pregnancy test within 72hours before starting the study.
Participants must agree to use effective birth control from at least 21 days beforejoining the study until the end of the study.
Participants must agree not to try to become pregnant through any method during thestudy.
Exclusion
Exclusion Criteria:
Participants cannot have had a blood transfusion within the last 120 days.
Participants cannot have received experimental treatments within the last 30 days.
Participants cannot weigh less than 35 kg (about 77 lbs).
Participants cannot plan to join another clinical trial during this study.
Participants cannot be pregnant or breastfeeding.
Participants cannot have received an HIV vaccine in a previous trial (unless it wasa placebo, subject to Protocol Safety Review Team's approval).
Participants cannot have had any live vaccines within the last 14 days or non-livevaccines within the last 7 days.
Participants cannot have had humanized or human monoclonal antibodies recently,except for certain HIV antibodies more than 12 months ago.
Participants cannot have had allergy shots within the last 14 days.
Participants cannot have taken immunosuppressive drugs within the last 30 days, withsome exceptions like nasal sprays or mild skin treatments.
Participants cannot participate if they have had serious allergic reactions to thecomponents of the study product.
Participants cannot have received immunoglobulin within the last 60 days.
Participants cannot have an autoimmune disease that requires immunosuppressivetreatment, unless it's mild and stable.
Participants cannot have an immune system deficiency.
Participants cannot have any significant medical condition or abnormal lab resultsthat could impact their health during the study.
Participants cannot have conditions that make repeated injections or blood drawsdifficult.
Participants cannot have conditions requiring active medical treatment that couldpose a risk during the study.
Participants cannot have conditions that could be confused with reactions to thestudy product.
Participants cannot have medical, social, or occupational conditions that wouldinterfere with the study.
Participants cannot have severe psychiatric conditions, like ongoing risk of suicideor recent history of suicide attempts.
Participants cannot be undergoing treatment for tuberculosis.
Participants cannot have severe asthma that requires frequent medication oremergency care.
Participants cannot have diabetes mellitus (DM) (well-controlled Type 2 DM or anisolated history of gestational diabetes are not exclusionary).
Participants blood pressure must be below 160/110 mmHg.
Participants cannot have any diagnosed bleeding disorders.
Participants cannot have active cancer but may be eligible if, in the investigator'sestimation, they have a reasonable assurance of sustained cure, or are unlikely toexperience recurrence of malignancy during the period of the study
Participants cannot have had seizures or taken seizure medications in the past 3years.
Participants cannot have a history of severe allergic reactions like anaphylaxis,unless it has been well-controlled for at least 5 years.
Participants cannot have acute or unstable hepatitis B or C, but stable chroniccases may be considered.
Study Design
Connect with a study center
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, 21040-360
BrazilActive - Recruiting
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro 3451190, 21040-360
BrazilSite Not Available
ACSA CRS
Iquitos, Maynas 1
PeruSite Not Available
ACSA CRS
Iquitos 3696183, Maynas 1
PeruSite Not Available
CITBM CRS (Site ID 31970)
Callao, 15081
PeruActive - Recruiting
Citbm Crs
Callao, 15081
PeruSite Not Available
CITBM CRS (Site ID 31970)
Callao 3946083, 15081
PeruSite Not Available
Citbm Crs
Callao 3946083, 15081
PeruSite Not Available
San Miguel CRS (Site #11302)
Lima, 32-15088
PeruActive - Recruiting
Via Libre
Lima, 15001
PeruSite Not Available
Via Libre (Site ID 31909)
Lima, 15001
PeruActive - Recruiting
Via Libre
Lima 3936456, 15001
PeruSite Not Available
Via Libre (Site ID 31909)
Lima 3936456, 15001
PeruSite Not Available
Perinatal HIV Research Unit (PHRU)
Johannesburg, Gaunteng 1862
South AfricaSite Not Available
Perinatal HIV Research Unit (PHRU)
Johannesburg 993800, Gaunteng 1862
South AfricaSite Not Available
Chatsworth CRS
Chatsworth, KwaZulu-Natal 4030
South AfricaSite Not Available
Chatsworth CRS
Chatsworth 1013675, KwaZulu-Natal 972062 4030
South AfricaSite Not Available
Setshaba Research Centre
Soshanguve - H, Soshanguve 0152
South AfricaSite Not Available
Setshaba Research Centre
Soshanguve-H, Soshanguve 0152
South AfricaSite Not Available
Setshaba Research Centre
Soshanguve-H 11205042, Soshanguve 0152
South AfricaSite Not Available
Groote Schuur HIV CRS
Cape Town, Western Cape 7925
South AfricaSite Not Available
Groote Schuur HIV CRS
Cape Town 3369157, Western Cape 1085599 7925
South AfricaSite Not Available
Alabama CRA (Site #31788)
Birmingham, Alabama 35222
United StatesActive - Recruiting
Alabama CRA (Site #31788)
Birmingham 4049979, Alabama 4829764 35222
United StatesSite Not Available
Bridge HIV, San Francisco Department of Public Health
San Francisco, California 94102
United StatesActive - Recruiting
Bridge HIV, San Francisco Department of Public Health
San Francisco 5391959, California 5332921 94102
United StatesSite Not Available
The Hope Clinic of the Emory Vaccine Research Center; Emory University
Decatur, Georgia 30030
United StatesActive - Recruiting
The Hope Clinic of the Emory Vaccine Research Center; Emory University
Decatur 4191124, Georgia 4197000 30030
United StatesSite Not Available
BIDMC VCRS (Site ID# 32077)
Boston, Massachusetts 02215
United StatesActive - Recruiting
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts 02115-6110
United StatesActive - Recruiting
Fenway Health
Boston, Massachusetts 02215-4302
United StatesActive - Recruiting
BIDMC VCRS (Site ID# 32077)
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston 4930956, Massachusetts 6254926 02115-6110
United StatesActive - Recruiting
Fenway Health
Boston 4930956, Massachusetts 6254926 02215-4302
United StatesActive - Recruiting
Columbia P&S CRS
New York, New York 10032
United StatesActive - Recruiting
University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467)
Rochester, New York 14642
United StatesActive - Recruiting
Columbia P&S CRS
New York 5128581, New York 5128638 10032
United StatesSite Not Available
University of Rochester Vaccines to Prevent HIV Infection CRS (Site ID 31467)
Rochester 5134086, New York 5128638 14642
United StatesSite Not Available
Chapel Hill CRS
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Chapel Hill CRS (Site #3201)
Chapel Hill, North Carolina 27599
United StatesActive - Recruiting
Chapel Hill CRS
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
Chapel Hill CRS (Site #3201)
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
Penn Prevention CRS
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
University of Pittsburgh CRS (Site 1001)
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Penn Prevention CRS
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
University of Pittsburgh CRS (Site 1001)
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesSite Not Available
Vanderbilt Vaccine (VV) CRS
Nashville, Tennessee 37232
United StatesActive - Recruiting
Vanderbilt Vaccine (VV) CRS
Nashville 4644585, Tennessee 4662168 37232
United StatesSite Not Available
Seattle Vaccine and Prevention CRS (Site ID# 30331)
Seattle, Washington 98104
United StatesActive - Recruiting
Seattle Vaccine and Prevention CRS
Seattle 5809844, Washington 5815135 98104
United StatesSite Not Available
Seattle Vaccine and Prevention CRS (Site ID# 30331)
Seattle 5809844, Washington 5815135 98104
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.