Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
For people living with HIV, antiretroviral therapy (ART) helps to stop the virus from multiplying. The goal of current HIV treatment is to have such a small amount of the virus in the blood that it does not show up on regular tests. HIV is also hidden in cells throughout the body and can start multiplying when ART is stopped.
This research study will test two new study drugs: 10-1074-LS and 3BNC117-LS. Both of these study drugs are antibodies against HIV. An antibody is generally a substance that the body makes in response to an infection. The antibodies being used in this study were made in a laboratory and were designed to attach to HIV and can block HIV from attacking cells in the body and from spreading to other parts of the body. These antibodies are being developed to potentially treat and prevent HIV.
The main purpose of this study is to see if the study drugs affect the level of HIV that remains in the blood cells while taking ART and the level of HIV in the blood after discontinuing taking ART. The study will also see if it is safe to give people these antibodies and if they cause any side effects.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Step 1 Inclusion Criteria:
Confirmed HIV-1, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study Step 1 entry AND Confirmed by one of the following:
NOTE: The term "licensed" refers to a US FDA or DAIDS Clinical Laboratory Oversight (DCLOT) approved test.
WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
[NOTE A: Persons who are of child-bearing potential are individuals who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, and who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy, tubal ligation, or bilateral salpingectomy.] [NOTE B: Acceptable documentation of hysterectomy and bilateral oophorectomy, tubal ligation, and tubal micro-inserts are written documentation or oral communication from a clinician or clinician's staff documented in source documents (physician report/letter, operative report or other source documentation in the patient record, discharge summary, laboratory report, etc.). Participant-reported history is acceptable for documentation of menopause.]
Acceptable methods of contraception include:
[NOTE: Documentation of partner sterility can come from the site personnel's review of participant's medical records, medical examination and/or semen analysis, or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents.]
Step 2 Inclusion Criteria:
Step 3 Inclusion Criteria
Step 4 Inclusion Criteria
Step 1 Exclusion Criteria:
Any clinically significant acute or chronic medical condition, other than HIV, that in the opinion of the investigator would preclude safe participation in the study or interfere with the validity of study results.
Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months. [NOTE: Minor surgical removal of localized skin cancers (squamous cell carcinoma, basal cell carcinoma) are not exclusionary.]
History of AIDS-defining illness within 3 years prior to enrollment.
History of systemic corticosteroids (e.g., an equivalent dose of prednisone of > 20 mg daily for >14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy or other medications considered significant by the trial physician within the last 12 weeks.
History of a severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis in the 2 years prior to enrollment.
History of chronic urticaria requiring current daily treatment.
Known history of active Hepatitis B or Hepatitis C infection. [NOTE: Participant is eligible if hepatitis C virus (HCV) cure or clearance is documented.]
History of or current clinical atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines, including a previous diagnosis of any of the following:
Any history of receipt of HIV vaccine candidate or HIV-specific monoclonal antibody therapy.
Participation in any clinical study of an investigational product within 28 days prior to study entry (day 0) or expected participation in such a study during participation in this study. [NOTE: Treatment or receipt of prophylaxis against other infectious pathogens such as SARS-CoV-2 or Monkeypox under Emergency Use Authorization within 28 days of study entry is not exclusionary.]
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Breastfeeding
Laboratory abnormalities in the parameters listed below, obtained by any Network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate EQA programs.
Use of prohibited medications with ART within 7 days prior to study entry, or planned use of prohibited medications during the period of study participation.
[NOTE: Use of St. John's wort within 7 days prior to study entry is acceptable but must be discontinued on the day of study entry]
Step 2 Exclusion Criteria:
Step 3 Exclusion Criteria
Step 4 Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
135 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
ACTG CT.gov Coordinator
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal