HIV -1 InfectionPhase 1NCT07698600
A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV
A Phase 1 study testing BNT168 in people with HIV -1 Infection, run by BioNTech SE at 4 sites in 2 countries.
Trial summary
This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and how it affects the amount of virus in the body. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV -1 Infection
- What is being tested?
- BNT168
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 4 Aug 2026to Feb 2028
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are 18 to 50 years of age inclusive at the time of giving informed consent.
- For PLWOH: Individuals who are HIV-1 and HIV-2 negative at Visit 0. For PLWH: Individuals who are HIV-1 positive and HIV-2 negative at Visit 0.
- Have not received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.
- Are overall healthy as defined in the protocol.
- Individuals who have screening hematology and/or blood chemistry laboratory values as defined in the protocol.
- For PLWOH, starting at Visit 0 and continuously until the last planned visit in this study, individuals who:
Show all 21Show fewer
- Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.
- Agree to discuss HIV disease risks.
- Agree to HIV infection risk reduction counseling.
- For PLWH, individuals who:
- Have been on stable continuous cART for at least 12 months (defined as no interruptions longer than 14 continuous days) and with no changes in the components of the cART for at least 12 weeks prior to Visit 1.
- Are not on a non-nucleoside reverse transcriptase inhibitor at screening.
- Have never received lenacapavir and have not received other long-acting antiretroviral therapies in the last 2 years (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).
- Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.
- Have a CD4+ T cell count of ≥500 cells/µL at Visit 0.
- Per medical history, any available prior CD4+ T cell count must be ≥350 cells/µL.
- Have plasma HIV-1 RNA levels of <50 cps/mL for ≥6 months prior to study entry per investigator review of records and/or participant history (single measurements of <200 cps/mL are allowed if preceded and followed by values of <50 cps/mL).
- Are willing to stop cART and undergo ATI at the timepoint defined in the protocol.
- Are willing to re-initiate cART upon meeting cART restart criteria.
- Site investigator anticipates that a fully active alternative cART regimen could be constructed and would be available in the event of virologic failure on the participant's current cART regimen.
- Agree not to donate blood from the time of first IMP administration until 90 days after the last IMP administration for PLWOH and until the End of Study Visit for PLWH.
Who cannot join
- Have had major surgery (e.g., major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before Visit 0, or will not have fully recovered from surgery, or have major surgery planned during the time the participants are expected to participate in the study.
- Have an abnormal electrocardiogram at Visit 0 as specified in the protocol.
- Have any existing condition which may affect IMP injection and/or assessment of local reactions, e.g., tattoos, severe scars, etc.
- Have any bleeding diathesis or condition associated with prolonged bleeding that, in the opinion of the investigator, could compromise their wellbeing if they participate in the study.
- Have any current febrile illness (body temperature >38.0°C/>100.4°F) or other acute illness within 48 hours prior to IMP administration
- Have any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, or any clinically significant cardiac disease per the investigator's judgment.
Show all 19Show fewer
- Have Grade ≥2 hypertension per Food and Drug Administration toxicity grading scale at screening.
- Have a known or suspected impairment/alteration of immune function, autoimmune disease, or immunodeficiency (except HIV for PLWH), including receipt of any immunostimulant, immunomodulator, immunosuppressive medication, immunoglobulin, or blood/plasma product within 60 days prior to Visit 1 or planned administration during the study. Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is acceptable.
- Have a history of malignancy within 5 years before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered in the investigator's judgment to have minimal risk of recurrence. Any malignancy that is an AIDS-defining illness per protocol is exclusionary regardless of perceived risk of recurrence.
- Have received any live vaccines within 28 days prior to Visit 0 or any other vaccines within 14 days prior to Visit 0 or who are planning to receive any vaccine within 28 days of each IMP dose. When possible, standard of care vaccinations should be planned with the study interventions in mind.
- For PLWH: Have a history of opportunistic infections and/or AIDS-defining illnesses according to the US Centers for Disease Control and Prevention 2014 and the National Institutes of Health 2024.
- For PLWOH: Have current untreated or incompletely treated active tuberculosis infection (by history or concerning symptoms). For PLWH: Have current untreated or incompletely treated active tuberculosis infection (by history or concerning symptoms or sputum molecular testing) or current latent tuberculosis infection (by blood interferon-gamma release assay [IGRA]). Not excluded: Participants who have a positive IGRA but were fully treated for latent or active tuberculosis infection, per history, review of available records, and per investigator discretion.
- For PLWH: Have untreated or incompletely treated syphilis or genital, oropharyngeal or rectal gonorrhea or chlamydia infection.
- For PLWH: Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.
- Have an estimated glomerular filtration rate of <45 mL/min/1.73 m2 using the 2021 chronic kidney disease epidemiology creatinine equation.
- History of any serious adverse reactions (including anaphylaxis, respiratory distress, angioedema, or urticaria) to vaccines or to vaccine components such as lipids.
- Have a history of progressive or severe neurologic disorder, seizure disorder, or Guillain-Barré syndrome.
- Have a history of diabetes mellitus type 1 or type 2, a screening hemoglobin A1c ≥6.5%, or are taking any medication for treatment of diabetes. (Not excluded: A history of isolated gestational diabetes.)
- NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
South Africa3 sites, 3 recruiting
- Not yet recruiting
Perinatal HIV Research Unit (PHRU)
Johannesburg, 1864
- Recruiting
Wits RHI - Shandukani Research
Johannesburg, 2001
- Recruiting
Clinical HIV Research Unit (CHRU)
Johannesburg, 2092
United States1 site, 1 recruiting
- Recruiting
The Crofoot Research Center
Houston, Texas, 77098
About this study
Official title: A Randomized, Placebo-controlled, Phase I/II Clinical Trial to Evaluate the Safety, Immunogenicity, and Impact on Virological Control of the Investigational RNA-based Vaccine BNT168 in Adults Living With or Without HIV
This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and how it affects the amount of virus in the body.
Read the detailed description
Currently, this study consists of one part (Part A) which will be a Phase I, randomized, placebo-controlled, double-blind, first-in-human (FIH), dose escalation with an initial proof-of-principle component. Depending on the safety and immunogenicity data generated in this study, the Phase II part of this study and/or some of the cohorts may not be initiated or may be terminated earlier by sponsor decision. In this study:
- Three cohorts of people living without HIV (PLWOH) will be randomized in a 5:1 ratio to receive BNT168 or placebo. Participants in these cohorts will receive 3 injections. BNT168 will be evaluated for safety, reactogenicity, and vaccine-induced immunogenicity in this population.
- Two cohorts of people living with HIV (PLWH), will be randomized in a 2:1 ratio to receive BNT168 or placebo. Participants in these cohorts will receive 4 injections. BNT168 will be evaluated in PLWH on combination antiretroviral therapy (cART) for safety, reactogenicity, and vaccine-induced immunogenicity in this population. An initial proof-of-principle assessment will be conducted in PLWH who undergo analytical treatment interruption (ATI) to evaluate viral kinetics after investigational medicinal product (IMP) administration. After the ATI period, cART will be restarted as per protocol.
For PLWOH, there will be an ~1-month screening period, ~2-month treatment period and an ~6-month follow-up period. The planned study duration per participant is ~9 months.
For PLWH, there will be an ~1-month screening period, ~6-month treatment period and an ~6-month follow-up period. The planned study duration per participant is maximum ~13 months.
- Conditions
- HIV -1 Infection
- Being tested
- BNT168, Placebo
- Keywords
- HIV (human immunodeficiency virus), combination antiretroviral therapy (cART), Acquired immunodeficiency syndrome (AIDS), Ribonucleic acid (RNA)-based vaccine
- 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.
BNT168Biological
Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections
PlaceboOther
Isotonic sodium chloride (NaCl) solution (0.9%). Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections
| Study group | Role | What they receive |
|---|---|---|
| A1 in PLWOH - BNT168 dose level 1 | Experimental | Not described Receives: Biological: BNT168 |
| A2 in PLWOH - BNT168 dose level 2 | Experimental | Not described Receives: Biological: BNT168 |
| A3 in PLWOH - BNT168 dose level 3 | Experimental | Not described Receives: Biological: BNT168 |
| A4 in PLWH - BNT168 dose level 2 | Experimental | This cohort will undergo ATI post vaccination Receives: Biological: BNT168 |
| A5 in PLWH - BNT168 dose level 3 | Experimental | This cohort will undergo ATI post vaccination Receives: Biological: BNT168 |
| PLWOH - Placebo | Placebo comparator | Not described Receives: Other: Placebo |
| PLWH - Placebo | Placebo comparator | PLWH participants receiving placebo will also undergo ATI post vaccination Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of at least one adverse event
In PLWOH and PLWH. By cohort and pooled placebo.
Measured: From dosing through 28 days after each IMP dose
Occurrence of at least one serious adverse event
In PLWOH and PLWH. By cohort and pooled placebo.
Measured: From Dose 1 through the end of study (up to 12 months)
Occurrence of at least one adverse event of special interest
In PLWOH and PLWH. By cohort and pooled placebo.
Measured: From Dose 1 through the end of study (up to 12 months)
Occurrence of at least one solicited local reaction (pain, erythema/redness, swelling) at the IMP injection site
In PLWOH and PLWH. By cohort and pooled placebo. From dosing through 7 days after each IMP dose.
Measured: Up to 7 days after each IMP dose
Occurrence of at least one solicited systemic event (vomiting, diarrhea, headache, fatigue/tiredness, myalgia/muscle pain, fever)
In PLWOH and PLWH. By cohort and pooled placebo. From dosing through 7 days after each IMP dose.
Measured: Up to 7 days after each IMP dose
Secondary outcomes (11)
Occurrence of cytokine positive cluster of differentiation (CD) 4+ T cells
In PLWOH and PLWH. By cohort and pooled placebo. For PLWOH, at 7 days post-Dose 2, and 7 days post-Dose 3. For PLWH, at 7 days post-Dose 2, 7 days post-Dose 3 and/or 7 days post-Dose 4. As assessed by multi-parameter intracellular cytokine staining (ICS) following stimulation with IMP-specific peptide pools.
Measured: Up to 7 days post-Dose 2, 3 and/or 4
Occurrence of cytokine positive CD8+ T cells
In PLWOH and PLWH. By cohort and pooled placebo. For PLWOH, at 7 days post-Dose 2 and 7 days post-Dose 3. For PLWH, at 7 days post-Dose 2, 7 days post-Dose 3 and/or 7 days post-Dose 4. As assessed by multi-parameter ICS following stimulation with IMP-specific peptide pools.
Measured: Up to 7 days post-Dose 2, 3 and/or 4
Occurrence of proliferating CD8+ T cell responses (measured by carboxifluorescein diacetate succinimidyl ester)
In PLWOH and PLWH. By cohort and pooled placebo. For PLWOH, at 28 days post-Dose 2 and 28 days post-Dose 3. For PLWH, at 28 days post-Dose 2, 28 days post-Dose 3 and 28 days post-Dose 4. As assessed by flow cytometry following stimulation with IMP-specific peptide pools.
Measured: At 28 days post-Dose 2, 3 and/or 4
Magnitude of CD4+ T cell counts from ATI start through cART restart
In PLWH. By cohort and pooled placebo.
Measured: Up to 168 days post ATI start
Change in CD4+ T cell count from ATI start to cART restart and end of study
In PLWH. By cohort and pooled placebo.
Measured: Up to 168 days post ATI start
Occurrence of absolute CD4+ T cell count <350 cells/µL from ATI start through cART restart
In PLWH. By cohort and pooled placebo.
Measured: Up to 168 days post ATI start
Occurrence of at least one adverse event from the start of ATI to cART restart
In PLWH. By cohort and pooled placebo.
Measured: Up to 168 days post ATI start
Occurrence of at least one serious adverse event from the start of ATI to cART restart
In PLWH. By cohort and pooled placebo.
Measured: Up to 168 days post ATI start
Occurrence of any acquired immunodeficiency syndrome (AIDS)-defining illness or opportunistic infection from the start of ATI to cART restart
In PLWH. By cohort and pooled placebo. AIDS-defining illnesses and opportunistic infections as listed in the protocol.
Measured: Up to 168 days post ATI start
Time from ATI start to loss of virologic control (HIV-1 plasma viral load >200 copies [cps]/mL, confirmed by the next measurement)
In PLWH. By cohort and pooled placebo.
Measured: Up to 168 days post ATI start
Time from ATI start to meeting cART restart criteria
In PLWH. By cohort and pooled placebo.
Measured: Up to 168 days post ATI start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start4 Aug 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV -1 InfectionStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698600
- Sponsor's protocol ID
- BNT168-01
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Phase I/II Clinical Trial to Evaluate the Safety, Immunogenicity, and Impact on Virological Control of the Investigational RNA-based Vaccine BNT168 in Adults Living With or Without HIV
- ClinicalTrials.gov ID
- NCT07698600
- Acronym / sponsor ID
- BNT168-01
- Conditions
- HIV -1 Infection
- Keywords
- HIV (human immunodeficiency virus), combination antiretroviral therapy (cART), Acquired immunodeficiency syndrome (AIDS), Ribonucleic acid (RNA)-based vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 13 Jul 2026 (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.
This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and how it affects the amount of virus in the body.
Detailed description
Currently, this study consists of one part (Part A) which will be a Phase I, randomized, placebo-controlled, double-blind, first-in-human (FIH), dose escalation with an initial proof-of-principle component. Depending on the safety and immunogenicity data generated in this study, the Phase II part of this study and/or some of the cohorts may not be initiated or may be terminated earlier by sponsor decision. In this study:
- Three cohorts of people living without HIV (PLWOH) will be randomized in a 5:1 ratio to receive BNT168 or placebo. Participants in these cohorts will receive 3 injections. BNT168 will be evaluated for safety, reactogenicity, and vaccine-induced immunogenicity in this population.
- Two cohorts of people living with HIV (PLWH), will be randomized in a 2:1 ratio to receive BNT168 or placebo. Participants in these cohorts will receive 4 injections. BNT168 will be evaluated in PLWH on combination antiretroviral therapy (cART) for safety, reactogenicity, and vaccine-induced immunogenicity in this population. An initial proof-of-principle assessment will be conducted in PLWH who undergo analytical treatment interruption (ATI) to evaluate viral kinetics after investigational medicinal product (IMP) administration. After the ATI period, cART will be restarted as per protocol.
For PLWOH, there will be an ~1-month screening period, ~2-month treatment period and an ~6-month follow-up period. The planned study duration per participant is ~9 months.
For PLWH, there will be an ~1-month screening period, ~6-month treatment period and an ~6-month follow-up period. The planned study duration per participant is maximum ~13 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A1 in PLWOH - BNT168 dose level 1 | Experimental | Biological: BNT168 |
| A2 in PLWOH - BNT168 dose level 2 | Experimental | Biological: BNT168 |
| A3 in PLWOH - BNT168 dose level 3 | Experimental | Biological: BNT168 |
| A4 in PLWH - BNT168 dose level 2 | Experimental | Biological: BNT168This cohort will undergo ATI post vaccination |
| A5 in PLWH - BNT168 dose level 3 | Experimental | Biological: BNT168This cohort will undergo ATI post vaccination |
| PLWOH - Placebo | Placebo comparator | Other: Placebo |
| PLWH - Placebo | Placebo comparator | Other: PlaceboPLWH participants receiving placebo will also undergo ATI post vaccination |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Are 18 to 50 years of age inclusive at the time of giving informed consent.
- For PLWOH: Individuals who are HIV-1 and HIV-2 negative at Visit 0. For PLWH: Individuals who are HIV-1 positive and HIV-2 negative at Visit 0.
- Have not received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.
- Are overall healthy as defined in the protocol.
- Individuals who have screening hematology and/or blood chemistry laboratory values as defined in the protocol.
Key exclusion criteria (19 listed)
- Have had major surgery (e.g., major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before Visit 0, or will not have fully recovered from surgery, or have major surgery planned during the time the participants are expected to participate in the study.
- Have an abnormal electrocardiogram at Visit 0 as specified in the protocol.
- Have any existing condition which may affect IMP injection and/or assessment of local reactions, e.g., tattoos, severe scars, etc.
- Have any bleeding diathesis or condition associated with prolonged bleeding that, in the opinion of the investigator, could compromise their wellbeing if they participate in the study.
- Have any current febrile illness (body temperature >38.0°C/>100.4°F) or other acute illness within 48 hours prior to IMP administration
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 |
|---|---|---|
| BNT168Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections | Biological | A1 in PLWOH - BNT168 dose level 1, A2 in PLWOH - BNT168 dose level 2, A3 in PLWOH - BNT168 dose level 3, A4 in PLWH - BNT168 dose level 2, A5 in PLWH - BNT168 dose level 3 |
| PlaceboIsotonic sodium chloride (NaCl) solution (0.9%). Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections | Other | PLWH - Placebo, PLWOH - Placebo |
Primary outcome
Occurrence of at least one adverse event
Time frame: From dosing through 28 days after each IMP dose
In PLWOH and PLWH. By cohort and pooled placebo.
Occurrence of at least one serious adverse event
Time frame: From Dose 1 through the end of study (up to 12 months)
In PLWOH and PLWH. By cohort and pooled placebo.
Occurrence of at least one adverse event of special interest
Time frame: From Dose 1 through the end of study (up to 12 months)
In PLWOH and PLWH. By cohort and pooled placebo.
Occurrence of at least one solicited local reaction (pain, erythema/redness, swelling) at the IMP injection site
Time frame: Up to 7 days after each IMP dose
In PLWOH and PLWH. By cohort and pooled placebo. From dosing through 7 days after each IMP dose.
Occurrence of at least one solicited systemic event (vomiting, diarrhea, headache, fatigue/tiredness, myalgia/muscle pain, fever)
Time frame: Up to 7 days after each IMP dose
In PLWOH and PLWH. By cohort and pooled placebo. From dosing through 7 days after each IMP dose.
11 secondary outcomes
Occurrence of cytokine positive cluster of differentiation (CD) 4+ T cells
Time frame: Up to 7 days post-Dose 2, 3 and/or 4
Occurrence of cytokine positive CD8+ T cells
Time frame: Up to 7 days post-Dose 2, 3 and/or 4
Occurrence of proliferating CD8+ T cell responses (measured by carboxifluorescein diacetate succinimidyl ester)
Time frame: At 28 days post-Dose 2, 3 and/or 4
Magnitude of CD4+ T cell counts from ATI start through cART restart
Time frame: Up to 168 days post ATI start
Change in CD4+ T cell count from ATI start to cART restart and end of study
Time frame: Up to 168 days post ATI start
Occurrence of absolute CD4+ T cell count <350 cells/µL from ATI start through cART restart
Time frame: Up to 168 days post ATI start
Occurrence of at least one adverse event from the start of ATI to cART restart
Time frame: Up to 168 days post ATI start
Occurrence of at least one serious adverse event from the start of ATI to cART restart
Time frame: Up to 168 days post ATI start
Occurrence of any acquired immunodeficiency syndrome (AIDS)-defining illness or opportunistic infection from the start of ATI to cART restart
Time frame: Up to 168 days post ATI start
Time from ATI start to loss of virologic control (HIV-1 plasma viral load >200 copies [cps]/mL, confirmed by the next measurement)
Time frame: Up to 168 days post ATI start
Time from ATI start to meeting cART restart criteria
Time frame: Up to 168 days post ATI start
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 14 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for HIV -1 Infection
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Active, not recruitingPhase 3
Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy
HIV-1-infection
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
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.
BioNTech Responsible Person study director
BioNTech SE
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BNT168 in people with HIV -1 Infection, run by BioNTech SE at 4 sites in 2 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 21 inclusion and 19 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 14 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 4 sites in South Africa, 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. 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?
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 BioNTech clinical trials patient information (+49 6131 9084 ext. 0, patients@biontech.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of at least one adverse event (time frame: From dosing through 28 days after each IMP dose). The study lists 5 primary outcomes in all. 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 14 Oct 2026.