Human Immunodeficiency VirusPhase 1NCT06819176
Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy
A Phase 1 study testing Lenacapavir in people with Human Immunodeficiency Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure. HIV can remain in the body, in infected cells called reservoirs. If a person stops taking ART, the HIV can rebound and reach high levels in their blood. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Lenacapavir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to 24 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Able to provide informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Aged 18 years to 75 years.
- In generally good health with an identified primary health care provider for medical management of HIV infection and willing to maintain a relationship with a primary health care provider while participating in the study.
- Confirmed HIV-1 infection.
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- Total HIV DNA reservoir size greater than 300 copies/106 CD4+ T cells.
- CD4+ T cell count >200 cells/mm^3 at screening.
- Documentation of continuous ART treatment >3 years with suppression of plasma viral level below the limit of quantitation (<40 copies/mL). Individuals with <= 2 blips (>40 copies/mL) over 48 weeks prior to screening may be included provided they satisfy the following criteria:
- The blips are <=200 copies/mL.
- Succeeding viral levels return to below the limit of quantification (<40 copies/mL) on subsequent testing.
- For individuals who can become pregnant (ie, participants who have not been postmenopausal 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), must have a negative pregnancy test at screening and within 48 hours prior to day 0. Participant-reported history is acceptable as documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, and vasectomy.
- Participants who can become pregnant must agree to use 1 acceptable method of contraception when engaging in sexual activities that can result in pregnancy from 10 days prior to the first dose of lenacapavir through study follow up. Acceptable methods of contraception include the following:
- Contraceptive subdermal implant.
- Intrauterine device or intrauterine system.
- Combined estrogen and progestogen oral contraceptive.
- Injectable progestogen.
- Contraceptive vaginal ring.
- Percutaneous contraceptive patches.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- History of AIDS-defining illness within 3 years prior to enrollment.
- History of systemic corticosteroids (eg, an equivalent dose of prednisone of >20 mg daily for >14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy, lenacapavir, or other medications considered significant by the principal investigator within the last 6 months.
- Any clinically significant acute or chronic medical condition (eg, autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), other than HIV infection, that in the opinion of the investigator would preclude participation.
- Hepatitis B or C infection as indicated by the presence of hepatitis B surface antigen or hepatitis C virus (HCV) RNA in blood.
- NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible.
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- Pregnancy or lactation.
- Any licensed vaccine (eg, hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to the study enrollment.
- Receipt of other investigational study agents within 28 days of enrollment and at any time during the study, including any experimental non-HIV vaccination within 2 weeks prior to enrollment.
- Systemic immunosuppressive medications received within 3 months prior to enrollment. The following are not excluded:
- Corticosteroid nasal spray or inhaler.
- Topical corticosteroids for mild, uncomplicated dermatitis.
- Oral/parenteral corticosteroids administered for non-chronic conditions not expected to recur (length of therapy 10 days, with completion in 30 days prior to enrollment).
- Cyclosporine eye drops
- Active drug or alcohol abuse or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Laboratory abnormalities in the parameters listed below:
- Absolute neutrophil count <1,000 cells/mm^3
- Hemoglobin <10 g/dL
- Platelet count <100,000 cells/mm^3
- ALT >1.5 x ULN
- AST >1.5 x ULN
- Total bilirubin >1.5 x ULN
- Estimated glomerular filtration rate <30 mL/min/1.73m^2
- Inability to undergo leukapheresis due to poor venous access or other medical conditions.
- Concurrent treatment with any of the medications listed below:
- Antiarrhythmics: digoxin
- Anticoagulants: direct oral anticoagulants (DOACs), rivaroxaban, dabigatran, edoxaban
- Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- Antiretroviral Agents: atazanavir/cobicistat, atazanavir/ritonavir, efavirenz, nevirapine, tipranavir/ritonavir
- Antimycobacterials: Rifabutin, rifampin, rifapentine
- Corticosteroids (systemic): dexamethasone, hydrocortisone/cortisone
- Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine
- Herbal products: St. John's wort c (Hypericum perforatum)
- HMG-CoA reductase inhibitors: lovastatin simvastatin
- Narcotic analgesics metabolized by CYP3A: fentanyl, oxycodone
- Tramadol
- Narcotic analgesic for treatment of opioid dependence: buprenorphine, methadone
- Opioid antagonist: naloxegol
- Phosphodiesterase-5 (PDE-5) inhibitors: sildenafil, tadalafil, vardenafil
- Sedatives/Hypnotics: midazolam (oral), triazolam
- Past or current medical findings, which, in the opinion of the investigator, may pose additional risk from participation in the study, may interfere with the individual's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
- Co-enrollment guidelines: Co-enrollment in other trials or protocols involving apheresis is restricted, other than enrollment on observational studies. Co-enrollment in an interventional trial will require the approval of the principal investigator. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the principal investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Kathleen Gittens, RN, 301-435-8003, kathleen.gittens@nih.gov
About this study
Background:
Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure. HIV can remain in the body, in infected cells called reservoirs. If a person stops taking ART, the HIV can rebound and reach high levels in their blood. Researchers want to find ways to reduce the size of HIV reservoirs in people taking ART.
Read more
Objective:
To test a drug (lenacapavir) in people with HIV who are on effective ART. Lenacapavir, also called Sunlenca, is already approved for use in people with HIV who cannot be treated with standard ART.
Eligibility:
People aged 18 to 75 years with HIV that has been suppressed for at least 3 years with ART.
Design:
Participants will have 13 clinic visits over 2 years.
Participants will be screened. They will have a physical exam with blood tests. They will maintain their ART throughout the study.
Participants will undergo leukapheresis up to 6 times. Blood will be drawn via a tube in an arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a second tube.
Two-thirds of participants will take lenacapavir in addition to their regular ART. They will receive the drug as an injection under the skin 3 times at 6-month intervals. They will also take lenacapavir as 2 pills swallowed by mouth on the first 2 days of the study.
...
Read the detailed description
STUDY DESCRIPTION:
This is a treatment intensification study designed to ascertain the effects of lenacapavir intensification in people with HIV (PWH) with viral suppression on effective antiretroviral therapy (ART). Participants who fulfill the inclusion and exclusion criteria will be randomized in a 2:1 ratio to either continue their ART plus lenacapavir or continue their ART alone. Up to 24 participants will receive lenacapavir at 927 mg by subcutaneous (SC) injection (2x1.5 mL injections) on day 0 and 600 mg orally (2x300 mg tablets) on days 0 and 1, followed by 927 mg by subcutaneous injection (2x1.5 mL injections) at weeks 24 and 48. Participants in the lenacapavir arm will be followed for 48 weeks following the final injection. Up to 12 participants will remain on their prescribed ART regimens only. The size and rate of decay of intact HIV DNA reservoirs will be longitudinally monitored in each study group. All participants will undergo leukapheresis at baseline (prior to the first lenacapavir injection, if applicable) and at weeks 12, 24, 48, 72, and 96.
OBJECTIVES:
Primary Objective:
-To investigate the effect of the presence or absence of lenacapavir on intact HIV proviral DNA reservoirs in PWH who had been receiving virologically suppressive (<40 copies/mL) ART for greater than 3 years.
Secondary Objectives:
-To investigate the effect of the presence or absence of lenacapavir on residual plasma viremia (<40 copies/mL) in PWH who have been receiving virologically suppressive ART for greater than 3 years.
Exploratory Objectives:
- To investigate the effect of the presence or absence of lenacapavir on frequencies of CD4+ T cells carrying a) cell-associated HIV RNA, b) inducible HIV, and c) replication-competent virus.
- To investigate phenotypic changes on B, T, and natural killer cell markers.
- To investigate levels of HIV-specific T cells.
- To examine biomarkers in plasma.
ENDPOINTS:
Primary Endpoint:
-Changes in the intact HIV proviral reservoir size, measured by intact HIV proviral DNA assay (IPDA) in the blood CD4+ T-cell compartment from baseline to weeks 12, 24, 48, 72, and 96.
Secondary Endpoint:
-Changes in the residual HIV plasma viremia (1-39 copies/mL) from baseline to weeks 12, 24, 48, 72, and 96 (weeks 1, 2, 4, and 8 are optional).
Exploratory Endpoints:
- Frequencies of CD4+ T cells carrying cell-associated HIV RNA, inducible virion-associated HIV RNA, and replication-competent virus before, during, and after ART intensification with lenacapavir.
- Immunophenotyping of B, T, and natural killer cells using highdimensional flow cytometry before, during, and after ART intensification with lenacapavir.
- Measurements of the frequency of HIV-specific CD4+ and CD8+ T cells using overlapping HIV Gag peptides before, during, and after ART intensification with lenacapavir.
- Measurements of plasma biomarkers of immune activation and inflammation before, during, and after ART intensification with lenacapavir.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Lenacapavir
- Keywords
- HIV, ART intensification, Reservoir, lenacapavir, persistence
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenacapavirDrug
Lenacapavir (Sunlenca) is a prescription drug approved by the Food and Drug Administration (FDA) for the treatment of people living with multidrug-resistant HIV. Lenacapavir is always used as part of a combination ART regimen. Participants will receive lenacapavir at 927 mg by subcutaneous injection (2x1.5 mL injections) on day 0 and 600 mg orally (2x300 mg tablets) on days 0 and 1, followed by 927 mg by subcutaneous injection (2x1.5 mL injections) at weeks 24 and 48.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Participants will receive lenacapavir at 927 mg by subcutaneous injection (2x1.5 mL injections) on day 0 and 600 mg orally (2x300 mg tablets) on days 0 and 1, followed by 927 mg by subcutaneous injection (2x1.5 mL injections) at weeks 24 and 48. Receives: Drug: Lenacapavir |
| Standard of Care | No intervention | Participants who are not randomized to lenacapavir will remain on their current ART regimens. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the intact HIV proviral reservoir size, measured by IPDA in the blood CD4+ T-cell compartment from baseline to weeks 12, 24, 48, 72, and 96.
To compare the effect of the presence or absence of lenacapavir on intact HIV proviral DNA reservoirs in PWH who had been receiving virologically suppressive (<40 copies/mL) ART for greater than 3 years.
Measured: Through week 96.
Secondary outcomes (1)
Changes in the residual HIV plasma viremia (1-39 copies/mL) from baseline to weeks 12, 24, 48, 72, and 96 in the lenacapavir and control arm.
To compare the effect of the presence or absence of lenacapavir on residual plasma viremia (<40 copies/mL) in PWH who have been receiving virologically suppressive (<40 copies/mL) ART for greater than 3 years.
Measured: Through week 96.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start20 Jan 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion24 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Chuen-Yen C Lau, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819176
- Sponsor's protocol ID
- 10002211
- Other IDs
- 002211-I
- Status last verified
- 8 Oct 2026
- First submitted
- 8 Feb 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with collaborators for analysis purposes. It will mostly be coded.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT06819176
- Acronym / sponsor ID
- 10002211
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV, ART intensification, Reservoir, lenacapavir, persistence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 24 Jan 2029 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure. HIV can remain in the body, in infected cells called reservoirs. If a person stops taking ART, the HIV can rebound and reach high levels in their blood. Researchers want to find ways to reduce the size of HIV reservoirs in people taking ART.
Objective:
To test a drug (lenacapavir) in people with HIV who are on effective ART. Lenacapavir, also called Sunlenca, is already approved for use in people with HIV who cannot be treated with standard ART.
Eligibility:
People aged 18 to 75 years with HIV that has been suppressed for at least 3 years with ART.
Design:
Participants will have 13 clinic visits over 2 years.
Participants will be screened. They will have a physical exam with blood tests. They will maintain their ART throughout the study.
Participants will undergo leukapheresis up to 6 times. Blood will be drawn via a tube in an arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a second tube.
Two-thirds of participants will take lenacapavir in addition to their regular ART. They will receive the drug as an injection under the skin 3 times at 6-month intervals. They will also take lenacapavir as 2 pills swallowed by mouth on the first 2 days of the study.
...
Detailed description
STUDY DESCRIPTION:
This is a treatment intensification study designed to ascertain the effects of lenacapavir intensification in people with HIV (PWH) with viral suppression on effective antiretroviral therapy (ART). Participants who fulfill the inclusion and exclusion criteria will be randomized in a 2:1 ratio to either continue their ART plus lenacapavir or continue their ART alone. Up to 24 participants will receive lenacapavir at 927 mg by subcutaneous (SC) injection (2x1.5 mL injections) on day 0 and 600 mg orally (2x300 mg tablets) on days 0 and 1, followed by 927 mg by subcutaneous injection (2x1.5 mL injections) at weeks 24 and 48. Participants in the lenacapavir arm will be followed for 48 weeks following the final injection. Up to 12 participants will remain on their prescribed ART regimens only. The size and rate of decay of intact HIV DNA reservoirs will be longitudinally monitored in each study group. All participants will undergo leukapheresis at baseline (prior to the first lenacapavir injection, if applicable) and at weeks 12, 24, 48, 72, and 96.
OBJECTIVES:
Primary Objective:
-To investigate the effect of the presence or absence of lenacapavir on intact HIV proviral DNA reservoirs in PWH who had been receiving virologically suppressive (<40 copies/mL) ART for greater than 3 years.
Secondary Objectives:
-To investigate the effect of the presence or absence of lenacapavir on residual plasma viremia (<40 copies/mL) in PWH who have been receiving virologically suppressive ART for greater than 3 years.
Exploratory Objectives:
- To investigate the effect of the presence or absence of lenacapavir on frequencies of CD4+ T cells carrying a) cell-associated HIV RNA, b) inducible HIV, and c) replication-competent virus.
- To investigate phenotypic changes on B, T, and natural killer cell markers.
- To investigate levels of HIV-specific T cells.
- To examine biomarkers in plasma.
ENDPOINTS:
Primary Endpoint:
-Changes in the intact HIV proviral reservoir size, measured by intact HIV proviral DNA assay (IPDA) in the blood CD4+ T-cell compartment from baseline to weeks 12, 24, 48, 72, and 96.
Secondary Endpoint:
-Changes in the residual HIV plasma viremia (1-39 copies/mL) from baseline to weeks 12, 24, 48, 72, and 96 (weeks 1, 2, 4, and 8 are optional).
Exploratory Endpoints:
- Frequencies of CD4+ T cells carrying cell-associated HIV RNA, inducible virion-associated HIV RNA, and replication-competent virus before, during, and after ART intensification with lenacapavir.
- Immunophenotyping of B, T, and natural killer cells using highdimensional flow cytometry before, during, and after ART intensification with lenacapavir.
- Measurements of the frequency of HIV-specific CD4+ and CD8+ T cells using overlapping HIV Gag peptides before, during, and after ART intensification with lenacapavir.
- Measurements of plasma biomarkers of immune activation and inflammation before, during, and after ART intensification with lenacapavir.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Drug: LenacapavirParticipants will receive lenacapavir at 927 mg by subcutaneous injection (2x1.5 mL injections) on day 0 and 600 mg orally (2x300 mg tablets) on days 0 and 1, followed by 927 mg by subcutaneous injection (2x1.5 mL injections) at weeks 24 and 48. |
| Standard of Care | No intervention | –Participants who are not randomized to lenacapavir will remain on their current ART regimens. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Able to provide informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Aged 18 years to 75 years.
- In generally good health with an identified primary health care provider for medical management of HIV infection and willing to maintain a relationship with a primary health care provider while participating in the study.
Key exclusion criteria (42 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- History of AIDS-defining illness within 3 years prior to enrollment.
- History of systemic corticosteroids (eg, an equivalent dose of prednisone of >20 mg daily for >14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy, lenacapavir, or other medications considered significant by the principal investigator within the last 6 months.
- Any clinically significant acute or chronic medical condition (eg, autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), other than HIV infection, that in the opinion of the investigator would preclude participation.
- Hepatitis B or C infection as indicated by the presence of hepatitis B surface antigen or hepatitis C virus (HCV) RNA in blood.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenacapavirLenacapavir (Sunlenca) is a prescription drug approved by the Food and Drug Administration (FDA) for the treatment of people living with multidrug-resistant HIV. Lenacapavir is always used as part of a combination ART regimen. Participants will receive lenacapavir at 927 mg by subcutaneous injection (2x1.5 mL injections) on day 0 and 600 mg orally (2x300 mg tablets) on days 0 and 1, followed by 927 mg by subcutaneous injection (2x1.5 mL injections) at weeks 24 and 48. | Drug | Interventional |
Primary outcome
Changes in the intact HIV proviral reservoir size, measured by IPDA in the blood CD4+ T-cell compartment from baseline to weeks 12, 24, 48, 72, and 96.
Time frame: Through week 96.
To compare the effect of the presence or absence of lenacapavir on intact HIV proviral DNA reservoirs in PWH who had been receiving virologically suppressive (<40 copies/mL) ART for greater than 3 years.
1 secondary outcome
Changes in the residual HIV plasma viremia (1-39 copies/mL) from baseline to weeks 12, 24, 48, 72, and 96 in the lenacapavir and control arm.
Time frame: Through week 96.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will be shared with collaborators for analysis purposes. It will mostly be coded.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chuen-Yen C Lau, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenacapavir in people with Human Immunodeficiency Virus, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 19 inclusion and 42 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen R Gittens ((301) 435-8003, kathleen.gittens@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the intact HIV proviral reservoir size, measured by IPDA in the blood CD4+ T-cell compartment from baseline to weeks 12, 24, 48, 72, and 96. (time frame: Through week 96.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.