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HIV-1-infectionPhase 1PAUSENCT06031272

Pausing Antiretroviral Treatment Under Structured Evaluation

A Phase 1 study testing 3BNC117-LS-J and 10-1074-LS-J in people with HIV-1-infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 9 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to see if it is safe to give the study antibodies (3BNC117-LS-J and 10-1074-LS-J) by intravenous infusion to people with HIV (PWH), and to see if they cause any side effects. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
HIV-1-infection
What is being tested?
3BNC117-LS-J and 10-1074-LS-J
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
9 sitesin 3 countries
Study dates
28 May 2024to 25 Jun 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Step 1:
  • Ability and willingness of participant to provide informed consent.
  • HIV-1 infection, documented by:
  • Any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study 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)
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  • HIV-1 antigen, or
  • Plasma HIV-1 RNA viral load, or
  • A licensed Western blot [NOTE: The term "licensed" refers to a U.S. FDA-approved kit.]
  • On stable suppressive ART for at least 96 weeks prior to study entry. [NOTE: ART interruptions of up to 7 days occurring ≥90 days prior to study entry are acceptable. Within- and between-class changes in ART within the year prior to study entry are acceptable.]
  • Plasma HIV-1 RNA levels of <50 copies/mL for at least 96 weeks prior to study entry at any licensed local laboratory or Network-approved non-US laboratory that is VQA certified.
  • [NOTE: Two "blips" (i.e., plasma HIV-1 RNA >50 and <400 copies/mL) are allowed if each blip is preceded and followed by values <50 copies/mL. At least one viral load measurement in greater than 56 days and within 48 weeks prior to the entry visit and another viral load within 56 days prior to the entry visit must be available for review. ]
  • CD4+ cell count >450 cells/µL obtained within 56 days prior to study entry at any Network-approved non-US laboratory that is IQA certified.
  • The following laboratory values obtained within 56 days prior to study entry by any Network-approved non-US laboratory that is EQA certified:
  • Absolute neutrophil count (ANC) ≥750/mm3
  • Hemoglobin ≥10 g/dL for participants who were assigned female sex at birth, ≥11.0 g/dL for participants who were assigned male sex at birth
  • Platelet count ≥100,000/mm3
  • Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2 as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation
  • ALT <2.5 times the institutional upper limit of normal
  • Direct bilirubin within the institutional range of normal
  • For participants who can become pregnant (i.e., participants assigned female sex at birth who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy), negative serum or urine pregnancy test within 24 hours prior to Step 1 entry (Day 0) by a Network-approved non-US laboratory that is EQA certified. [NOTE: Participant-reported history is acceptable documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts.]
  • Participants who can become pregnant must agree to use two methods of contraception, one of which must be from the highly effective methods for contraception listed below. Barrier methods of contraception are permitted for the second method of contraception. Contraception must be used from 10 days prior to study entry and participants must agree to use contraception for 36 weeks after receiving study treatment, and until ART is reinitiated and viral suppression is achieved. Acceptable methods of contraception include:
  • 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 partner is the sole partner for that participant. The documentation of partner sterility can come from the site personnel's review of 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.
  • Participants who can impregnate (i.e., individuals assigned male sex at birth who have not undergone a sterilizing procedure) a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 days prior to study entry and for 36 weeks after receiving study treatment to avoid impregnating a partner.
  • Willingness to use barrier protection (i.e., external or internal) for all sexual activity during ATI and until viral suppression is achieved after re-starting ART.
  • Willingness to not participate in other research studies of investigational drugs while on this study.
  • Willingness to provide a specimen for a genetic test (HLA Typing).
  • Step 2:
  • Participant who has completed Step 1, including receipt of both bNAb infusions, and has not met ART restart criteria described in the protocol at any time during Step 1.
  • Willingness to continue ATI and be monitored.
  • Step 3:
  • Meeting one or more ART restart criteria described in the protocol OR
  • Despite completing 72 weeks of ATI without meeting one or more ART restart criteria, participant declines participation in A5385, or is unable to enter A5385.

Who cannot join

  • Step 1:
  • History of any AIDS-defining illness prior to study entry. [NOTE: History of treated and resolved pulmonary TB will not be exclusionary.]
  • Known nadir CD4+ cell count <200 cells/µL. [NOTE: If laboratory reports or clinical notes are not available, then participant recall is acceptable for nadir CD4 T-cell count.]
  • Any clinically significant acute or chronic medical condition (such as autoimmune diseases or active tuberculosis), other than HIV infection, that in the opinion of the investigator would preclude participation.
  • Any history of an HIV-associated malignancy, including Kaposi's sarcoma, or any type of lymphoma or virus-associated cancers.
  • History of Progressive Multifocal Leukoencephalopathy (PML).
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  • Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery within 36 months prior to study entry 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) is not exclusionary.]
  • Receipt of an NNRTI within 30 days prior to study entry.
  • Receipt of cabotegravir-LA IM, rilpivirine-LA IM, or other long-acting ARVs within 24 months prior to study entry.
  • Receipt of any standard-of-care (SOC) vaccines within 7 days prior to study entry.
  • Known resistance to all drugs within two or more ARV drug classes. [NOTE: M184V/I is an exception and should not be considered when assessing this criterion. Prior HIV resistance testing is not required.]
  • History of systemic corticosteroids (>14 days concurrent use), immunosuppressive anti-cancer or other immunosuppressive agents, interleukins, systemic interferons, systemic chemotherapy, or other medications considered significant by the investigator within the 24 weeks prior to study entry.
  • ART initiated during acute infection (defined as p24, HIV NAAT, or HIV RNA PCR positive, and negative or indeterminate HIV antibody testing).
  • Any history of receipt of therapeutic HIV vaccine or HIV monoclonal antibody therapy.
  • Participation in any clinical study of an investigational product within 12 weeks prior to study entry or expected participation in such a study while on A5416.
  • Known allergy/sensitivity or any hypersensitivity to components of either study agent or their formulation.
  • Breastfeeding.
  • Chronic hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg), hepatitis C antibody without documented history of prior treatment and clearance or virus RNA (HCV-RNA) or HCV antigen in blood at a Network-approved non-US laboratory that is EQA certified.
  • Current untreated or incompletely treated active tuberculosis disease or untreated latent tuberculosis infection. [NOTE: Individuals who are on treatment for latent TB with at least 4 weeks of treatment completed are not excluded.]
  • History of or current clinical atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines, including a previous diagnosis of any of the following:
  • 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
  • Diagnosis of cirrhosis.
  • Diagnosis of untreated syphilis, gonorrhea, or chlamydia. [NOTE: Individuals who began treatment at least 3 days prior to study entry for any of the above are not excluded.]
  • No Step 2 and Step 3 Exclusion Criteria

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

South Africa6 sites

  • Groote Schuur HIV CRS (31708)

    Cape Town, Western Cape, 7925

  • CAPRISA eThekwini CRS (31422)

    Durban, KwaZulu-Natal, 4011

  • Ward 21 CRS (31966)

    Johannesburg, Gauteng, 2001

  • Aurum Institute Klerksdorp CRS (30325)

    Klerksdorp, North West

  • Rustenburg CRS (31684)

    Rustenburg, North West, 0300

  • Soweto HVTN CRS (30351)

    Soweto, Gauteng, 1862

Other trials in South Africa

Malawi2 sites

  • Blantyre CRS (30301)

    Blantyre

  • Lilongwe Malawi CRS (12001)

    Lilongwe

Other trials in Malawi

Botswana1 site

  • Gaborone CRS (12701)

    Molepolole

Other trials in Botswana

About this study

Official title: A Phase I, Randomized, Placebo-Controlled Study of the Safety, Antiviral & Immunomodulatory Activity of Broadly Neutralizing Antibodies 3BNC117-LS-J and 10-1074-LS-J in Combination in ART-treated Adults in Sub-Saharan Africa Living With HIV During a Monitored Analytical Treatment Interruption

The main purpose of this study is to see if it is safe to give the study antibodies (3BNC117-LS-J and 10-1074-LS-J) by intravenous infusion to people with HIV (PWH), and to see if they cause any side effects. In addition, to see how the study antibodies affect the level of HIV in the blood when participants are not taking regular HIV treatment for an extended period. This extended period of not taking regular HIV treatment is called an analytical treatment interruption (ATI).

Conditions
HIV-1-infection
Being tested
3BNC117-LS-J, 10-1074-LS-J, Placebo for 3BNC117-LS-J, Placebo for 10-1074-LS-J

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3BNC117-LS-JDrug

    Administered by intravenous (IV) infusion

  • 10-1074-LS-JDrug

    Administered by intravenous (IV) infusion

  • Placebo for 3BNC117-LS-JDrug

    Administered by intravenous (IV) infusion

  • Placebo for 10-1074-LS-JDrug

    Administered by intravenous (IV) infusion

Study groups in NCT06031272
Study groupRoleWhat they receive
Arm A: 30 mg/kg 3BNC117-LS-J + 10 mg/kg 10-1074-LS-JExperimentalParticipants will receive 30 mg/kg 3BNC117-LS-J and 10 mg/kg 10-1074-LS-J, administered as two intravenous (IV) infusions at Step 1 entry (Day 0). Participants will discontinue ART on Day 2.
Receives: Drug: 3BNC117-LS-J; Drug: 10-1074-LS-J
Arm B: PlaceboPlacebo comparatorParticipants will receive dose-volume equivalent placebo IV infusions for both 3BNC117-LS-J and 10-1074-LS-J at Step 1 entry (Day 0). Participants will discontinue ART on Day 2.
Receives: Drug: Placebo for 3BNC117-LS-J; Drug: Placebo for 10-1074-LS-J

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of a Grade ≥3 or higher systemic AE or any AE (regardless of grade) leading to premature study or treatment discontinuation

    The proportion of participants reporting a Grade ≥3 systemic (i.e., not a local reaction) adverse event (AE) or any AE (regardless of grade) leading to premature study or treatment discontinuation at least possibly related (as judged by the CMC, blinded to active/placebo treatment) to the combination of 3BNC117-LS-J and 10-1074-LS-J.

    An AE is any unfavorable and unintended sign, symptom, or diagnosis occurring in a study participant during the conduct of the study regardless of the attribution. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening, 5=death.

    Measured: Step 1 Entry (Day 0) through to 48 weeks

  2. Viral suppression

    The difference in proportion of participants with viral suppression during analytical treatment interruption (ATI) between those receiving 3BNC117-LS-J and 10-1074-LS-J and those receiving placebo. Viral suppression is defined as no confirmed HIV-1 RNA >200 copies/mL, at or prior to week 24 of ART discontinuation.

    Measured: Step 1 Entry (Day 0) through to Week 24

Secondary outcomes (12)

  1. Viral rebound at or prior to week 24 of ART discontinuation

    The cumulative probability of viral rebound at or prior to Week 24 in each treatment arm. Viral rebound is defined as confirmed HIV-1 RNA greater than 200 copies/mL.

    Measured: Step 1 Entry (Day 0) through Week 24

  2. HIV-1 RNA levels <50 copies/mL through week 24 of ART discontinuation

    The cumulative probability of participants maintaining HIV-1 RNA <50 copies/mL through Week 24 in each treatment arm.

    Measured: Step 1 Entry (Day 0) through Week 24

  3. Frequency of participants who do not meet the virologic or immunologic components of the ART resumption criteria while serum bNAb concentrations are ≥10 mcg/mL

    The number of participants in the active arm with serum bNAb concentrations (of both 3BNC-117-LS-J and 10-1074-LS-J) greater than or equal to 10 mcg/mL who have not met the viral load or CD4+ T cell components of the ART restart criteria at Step 1 and Step 2 study visits.

    Measured: Step 1 Entry (Day 0) until ART restart (Step 3 Entry)

  4. Frequency of participants who do not meet the virologic or immunologic components of the ART resumption criteria for 24 weeks after serum bNAb concentrations fall below 10 mcg/mL.

    The number of participants in the active arm with serum bNAb concentrations (of both 3BNC-117-LS-J and 10-1074-LS-J) less than 10 mcg/mL who have not met the viral load or CD4+ T cell components of the ART restart criteria at Step 1 and Step 2 study visits.

    Measured: Step 1 Entry (Day 0) until ART restart (Step 3 Entry)

  5. Frequency of participants who remain off ART and do not meet ART resumption criteria by study week in Step 1 and 2.

    The number of participants who remain of ART and do not meet ART resumption criteria will be tabulated at each study visit in Step 1 and 2.

    Measured: Step 1 Entry (Day 0) until ART restart (Step 3 Entry)

  6. Time to meeting the virologic or immunologic components of the ART resumption criteria.

    Time to meeting the viral load (virologic) or CD4+ T cell (immunologic) components of the ART resumption criteria estimated using Kaplan-Meier methods.

    Measured: Step 1 Entry (Day 0) until ART restart (Step 3 Entry)

  7. AUC of 3BNC117-LS-J and 10-1074-LS-J

    The Area Under the Concentration (AUC) time curve for each participant calculated from available bNAb concentrations measured during study follow-up in the active treatment arm.

    Measured: Step 1 Entry (Day 0) through study follow-up

  8. Clearance of 3BNC117-Ls-J and 10-1074-LS-J

    The clearance, describing the relationship between concentration and the rate of elimination from the body, for each participant will be calculated from available bNAb concentrations measured during study follow-up in the active treatment arm.

    Measured: Step 1 Entry (Day 0) until ART restart (Step 3 Entry)

  9. Concentration of 3BNC117-LS-J and 10-1074-LS-J at the time of viral rebound.

    The observed concentration of 3BNC117-LS-J and 10-1074-LS-J at the time of the first viral rebound (i.e., the first instance of confirmed HIV-1 RNA > 200 copies/mL) in the active treatment arm.

    Measured: Step 1 Entry (Day 0) until ART restart (Step 3 Entry)

  10. Number of participants who develop anti-3BNC117-LS-J and/or anti-10-1074-LS-J antibodies (ADA).

    The number of participants who develop anti-3BNC117-LS-J and/or anti-10-1074-LS-J antibodies at any point during study follow-up (cumulative incidence) in the active treatment arm.

    Measured: Step 1 Entry (Day 0) until ART restart (Step 3 Entry)

  11. CD4+ T-cell counts (cells/mm3) through entire study follow-up

    Median CD4+ T-cell count at all required (i.e., not conditional) required visits during ATI and after ART restart in each treatment arm.

    Measured: Step 1 Entry (Day 0) through entire study follow-up

  12. Percent of participants who develop anti-3BNC117-LS-J and/or anti-10-1074-LS-J antibodies (ADA).

    The percent of participants who develop anti-3BNC117-LS-J and/or anti-10-1074-LS-J antibodies at any point during study follow-up (cumulative incidence) in the active treatment arm.

    Measured: Step 1 Entry (Day 0) until ART restart (Step 3 Entry)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2023
  2. Study start28 May 2024
  3. Primary completion14 Oct 2025
  4. Study completion25 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06031272
Sponsor's protocol ID
ACTG A5416
Other IDs
UM1AI068636, HVTN 806, HPTN 108
Acronym
PAUSE
Status last verified
Aug 2026
First submitted
14 Aug 2023
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie results in the publication, after deidentification.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 3BNC117-LS-J and 10-1074-LS-J in people with HIV-1-infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Africa, Malawi, Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of a Grade ≥3 or higher systemic AE or any AE (regardless of grade) leading to premature study or treatment discontinuation (time frame: Step 1 Entry (Day 0) through to 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06031272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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