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.
A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may be used)
HIV-1 antigen
Plasma HIV-1 RNA viral load or
A licensed Western blot
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.
Parallel
3BNC117-LS
Drug30 mg/kg to be administered via IV at Step 1 (Day 1)
10-1074-LS
Drug10 mg/kg to be administered intravenously at Step 1 (Day 1)
Placebo for 3BNC117-LS
Drug0.9% Sodium Chloride Injection to be administered intravenously at Step 1 (Day 1)
Placebo for 10-1074-LS
Drug0.9% Sodium Chloride Injection) to be administered IV at Step 1 (Day 1)
Occurrence of Grade ≥2 Adverse Events (AE) or Serious Adverse Events (SAE)
Occurrence of Grade ≥2 AE or SAE that are possibly, probably, or definitely related to the study bNAbs during Step 1 (as judged by the CMC, blinded to active/placebo treatment).
Time from antiretroviral therapy (ART) discontinuation to sustained HIV-1 RNA ≥ 1000 copies/mL over a 4-week period (through step 2)
Sustained HIV-1 RNA ≥1000 copies/mL over a 4-week period means at least two measurements of HIV-1 RNA ≥1000 copies/mL over 4 weeks with no HIV-1 RNA \<1000 copies/mL measured between them. Through Step 2 means the 4-week period has started between Step 2 week 0 and week 24.Time to sustained HIV-1 RNA ≥1000 copies/mL over 4 weeks is the time to the first measurement that reaches that level over 4 weeks.
Time from ART discontinuation to ART restart
Time between ART discontinuation to the time participant meeting virologic, immunologic or clinical criteria (i.e., viral load, CD4+ T cell count, or development of severe acute retroviral syndrome) for ART restart
The proportion of participants who undergo ATI without indication of ART restart
Click on the lead sponsor to view all of their trials.
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
