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New treatment option for HIV-1-infection
Official title Antiretrovirals Combined With Antibodies for HIV-1 Cure In Africa
ClinicalTrials.gov ID: NCT06205602
What this study is testing
What is 3BNC117-LS?
3BNC117-LS is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hiv-1-infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Step 1
- 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...
- A second antibody test from different manufacturers or based on different principles and epitopes (combination antigen-antibody-based rapid tests may...
- HIV-1 antigen
- Plasma HIV-1 RNA viral load or
You likely can't join if
- Any clinically significant acute or chronic medical condition, other than HIV, that in the opinion of the investigator would preclude safe...
- Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are...
- 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...
- 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.
See the full eligibility criteria
Who can join
- Step 1
- 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:
- 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 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)...
- ART-naïve [NOTE: Prior use of PrEP or PEP is allowed, except use of long-acting ARVs (e.g., cabotegravir, rilpivirine) within the last 24 months.]
- CD4+ T cell count \>200 cells/mm3 obtained within 28 days prior to study entry at any Network-approved non-US laboratory that is (IQA) certified.
- Plasma HIV-1 RNA \>1000 copies/mL obtained within 28 days prior to study entry performed at any Network-approved non-US laboratory that operates in accordance with Good Clinical Laboratory Practices (GCLP) and...
- For study candidates of child-bearing potential, negative urine or serum pregnancy test within 72 hours prior to study entry by any Network-approved non-US laboratory or clinic that operates in accordance with GCLP and...
- Persons of child-bearing potential who are able to become pregnant must agree to use two methods of contraception, if participating in sexual activity that could lead to pregnancy. One contraceptive method must be from...
- Contraceptive subdermal implant
- Intrauterine device or intrauterine system
- Combined estrogen and progestogen oral contraceptive
- Injectable progestogen
- Contraceptive vaginal ring
- Percutaneous contraceptive patches
- Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this individual is the sole partner for that participant. [NOTE: Documentation of partner sterility can come...
- Individuals engaging in sexual activity that could lead to their partner becoming pregnant must agree to use a barrier method of contraception to avoid pregnancy in a spouse or partner of reproductive potential. The...
- Ability and willingness to use a barrier protection or abstinence from sexual intercourse during Step 1 until viral suppression is achieved, during the ATI period (Steps 2-3), and until plasma HIV-1 RNA is less than...
- Ability and willingness to initiate ART at enrollment.
- Ability and willingness to participate in scheduled study visits, including ATI per the SOE.
- Ability and willingness to provide informed consent. Step 2
- Documented negative hepatitis B virus (HBV) surface antigen (HBsAg) obtained within 16 weeks prior to Step 2 registration by any Network-approved non-US laboratory that operates in accordance with GCLP and participates...
- Documented negative HCV antibody (anti-HCV), negative HCV RNA PCR, or negative HCV antigen obtained within 16 weeks prior to Step 2 registration by any Network-approved non-US laboratory that operates in accordance with...
- Participants diagnosed with a bacterial sexually transmitted infection (STI) must have initiated treatment prior to Step 2 entry.
- Receipt of both bNAb infusions or placebo infusions during Step 1.
- HIV-1 RNA \<200 copies/mL obtained within 6 weeks prior to Step 2 registration at any Network-approved non-US laboratory that is VQA certified.
- CD4+ T cell count ≥450 cells/mm3 obtained within 6 weeks prior to Step 2 registration at any Network-approved non-US laboratory that is IQA certified.
- For participants of child-bearing potential, negative serum or urine pregnancy test within 48 hours prior to Step 2 entry at any Network-approved non-US laboratory or clinic that operates in accordance with GCLP and...
- Ability and willingness to use a barrier method of contraception or abstinence from sexual intercourse during Steps 2 and 3, and until plasma HIV-1 RNA is less than limit of detection, with all partners who are without...
- Ability and willingness to stop ART. Step 3 Has not met ART restart criteria.
- Completion of protocol Step 2.
- Willing to continue ATI. Step 4 Met ART restart criteria (section 3.0) during Step 2 or Step 3 OR Completed Step 3 and is not enrolling to ACTG A5385. Step 1
What rules you out
- 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...
- 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...
- 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...
- Acute myocardial infarction
- Acute coronary syndromes
- Stable or unstable angina
- Coronary or other arterial revascularization
- Stroke
- Transient ischemic attack
- Peripheral arterial disease presumed to be of atherosclerotic origin
- 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...
- 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...
- Absolute neutrophil count \<750 cells/mm3
- Hemoglobin \<9 gm/dL for volunteers who were assigned female sex at birth, \<10.0 g/dL for volunteers who were assigned male sex at birth
- Platelet count \<100,000 cells/mm3
- ALT \>3 x ULN
- AST \>3 x ULN
- Total bilirubin \>2 x ULN
- eGFR \<60 mL/min/1.73m2
- 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...
- Viral failure after Step 1 week 24.
- Participant never started ART.
- Participant interrupted ART ≥7 consecutive days in Step 1.
- Current use of an ART regimen that includes a long-acting or NNRTI component.
- Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during ATI.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Step 3 Exclusion Criteria
- Transfer to A5385 (The Post-Intervention Cohort Study) [NOTE: Participants may be offered co-enrollment or transfer to A5385, depending on ACTG identification of the preferred methodology for observation during extended...
- Intercurrent illness, new medical diagnosis, laboratory abnormality, sign, or symptom that, in the opinion of the site investigator, would place participant at higher risk of morbidity during analytic treatment...
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Step 4 Exclusion Criteria
- None
The study team makes the final eligibility decision.
Where it's taking place
- Gaborone, Botswana
- Johannesburg, Gauteng, South Africa
- Durban, KwaZulu-Natal, South Africa
- Durban, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gaborone, Botswana; Johannesburg, Gauteng, South Africa; Durban, KwaZulu-Natal, South Africa; Durban, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.