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HIVPhase 1/2NCT06508749

The Tatelo Plus Study

A Phase 1/2 study testing PGDM1400LS, VRC07-523LS and PGT121.414.LS in people with HIV and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Botswana.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to advance pediatric HIV treatment and cure research by evaluating the impact of a combination of three anti-HIV-1 broadly neutralizing antibodies (bNAbs) or analytic treatment interruption (ATI) on viral reservoir, immune function, and maintenance of HIV suppression in early-treated… Read more about this study

Who is it for?
Ages 24 weeks to 25 years
Conditions the study is for
HIV, HIV Infections
What is being tested?
PGDM1400LS, VRC07-523LS and PGT121.414.LS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
2 sitesBotswana
Study dates
11 Nov 2024to 18 Feb 2028
Phase
Phase 1/2
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 24 weeks to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Previously enrolled in the EIT/Tatelo, or Moso Cohort Study
  • Receiving prescribed ART for at least 24 weeks prior to study entry as determined by the site investigator based on participant/parent/guardian report and available medical records
  • 24 weeks to 12 years of age at enrollment, inclusive
  • If entering Step 1a: HIV-1 RNA <40 copies/mL for at least 24 weeks prior to entry, including documented suppression to <40 copies/mL within 30 days of Step 1 entry
  • If entering Step 1b: HIV-1 RNA <200 copies/mL for at least 24 weeks prior to entry, including documented suppression to <40 copies/mL within 30 days of Step 1 entry.
  • Normal temperature (<37.4°C axillary, or <38°C non-axillary) and no signs or symptoms of acute illness at entry as determined by the site investigator based on participant/parent/guardian report and available medical records
Show all 55Show fewer
  • Normal, grade 1 or grade 2 results for all of the following laboratory tests at screening, based on testing of specimens collected within 30 days prior to entry and grading per protocol:
  • Hemoglobin
  • Absolute neutrophil count
  • Platelet count
  • Alanine aminotransferase
  • Aspartate aminotransferase
  • Creatinine
  • For female participants who are able to become pregnant (defined as having reached menarche and not having undergone surgical sterilization), not pregnant based on testing performed from a specimen collected within 5 days prior to enrollment). Note: Pregnancy is not expected in Step 1 given the age range of eligible participants.
  • Expected to be available for the duration of participation and expected to comply with the visit schedule and other requirements as determined by the site investigator based on participant/parent/guardian report at entry
  • Not currently participating in another study of an investigational agent and is not expected to participate in any such study for the duration of participation, as determined by the site investigator based on participant/parent/guardian report at entry. Prior or current participation in the EIT/Tatelo or Moso cohort studies is permitted.
  • Parental/legal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7- 17 years of age
  • At or beyond the Week 24 visit in Step 1
  • Susceptible to at least 2 of the 3 bNAbs under study at or prior to Step 1 entry OR Negative EIA and negative qualitative DNA result at last available evaluation in Step 1 in the absence of available susceptibility data
  • No confirmed HIV-1 RNA ≥40 copies/mL throughout Step 1 and for at least 24 weeks prior to Step 1 entry
  • If entering from Step 1:
  • At or beyond the Week 24 visit in Step 1, with no confirmed HIV-1 RNA ≥40 copies/mL throughout Step 1
  • Not eligible for Step 2
  • No confirmed HIV-1 RNA ≥40 copies/mL for at least 96 weeks prior to Step 3 entry (or since 24 weeks of age if 96-120 weeks of age)
  • Detection of ≥60% of intact proviruses in heterochromatin DNA regions (i.e. non-genic DNA, satellite DNA, ZNF genes) from any PBMC sample analyzed by MIP-seq, and no recorded viremia (>40 copies/mL) after this evaluation OR Negative EIA and negative Qualitative HIV DNA result within 12 weeks prior to Step 3 entry
  • Approved for entry by Clinical Management Committee (CMC)
  • Willingness and ability to provide independent written informed consent for participation or parental/legal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7-17 years of age
  • If entering from Step 2:
  • At or beyond the Week 24 visit of Step 2, with HIV-1 RNA <40 copies/mL throughout Steps 1 and 2
  • No confirmed HIV-1 RNA ≥40 copies/mL for at least 96 weeks prior to Step 3 entry (or since 24 weeks of age if 96-120 weeks of age)
  • Negative EIA and negative qualitative DNA result within 12 weeks prior to Step 3 entry OR Detection of ≥60% of intact proviruses in heterochromatin DNA regions (i.e. non-genic DNA, satellite DNA, ZNF genes) from any PBMC sample analyzed by MIP-seq, and no recorded viremia (>40 copies/mL) after this evaluation entry AND approved for entry by CMC
  • For Moso participants, not currently being breastfed
  • Willingness and ability to provide independent written informed consent for participation or parental/legal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7-17 years of age
  • If entering Step 3 directly upon enrollment:
  • Previously enrolled in the EIT/Tatelo, Moso, or BHP Adolescent Cohort Study
  • 96 weeks to 25 years of age at enrollment, inclusive
  • "Non-encoding" virus: Detection of ≥60% of intact proviruses in heterochromatin DNA regions (i.e. non-genic DNA, satellite DNA, ZNF genes) from any PBMC sample analyzed by MIP-seq, and no recorded viremia (>40 copies/mL) after this evaluation OR "No intact virus": adolescent (13-25 years) with no intact HIV detected in at least 20 million PBMCs sampled within the prior 4 years
  • For "non-encoding" virus: Receiving prescribed ART prior to Step 3 entry, with HIV-1 RNA <40 copies/mL for at least 96 weeks prior to entry (or since 24 weeks of age if 96-120 weeks of age), including documented suppression to <40 copies/mL within 30 days of Step 3 entry
  • For "no intact virus": Receiving prescribed ART prior to Step 3 entry, with HIV-1 RNA <40 copies/mL for at least 10 years prior to entry, including documented suppression to <40 copies/mL within 30 days of Step 3 entry
  • Approved for entry by CMC
  • For Moso participants, not currently being breastfed
  • For female participants who are able to become pregnant (defined as having experienced menarche and not having undergone surgical sterilization), not pregnant based on testing performed from a specimen collected within 5 days prior to enrollment)
  • For female participants who are able to become pregnant (defined as having reached menarche and not having undergone surgical sterilization) and report sexual activity that could lead to pregnancy, willing to use two methods of contraception while on study. One of the two methods must be highly effective; highly effective methods include the following:
  • Contraceptive intrauterine device or intrauterine system
  • Subdermal contraceptive implant
  • Progestogen injections
  • Combined estrogen and progestogen oral contraceptive pills
  • Percutaneous contraceptive patch
  • Contraceptive vaginal ring The highly effective method must be initiated prior to enrollment. The second method must be a barrier method for dual protection against pregnancy and to avoid transmission of HIV during the ATI and other sexually transmitted infections.
  • For female participants who are able to become pregnant, not currently breastfeeding an infant, and not intending to breastfeed an infant for the duration of the study, based on participant/parent/guardian report at entry
  • For participants who report sexual activity, willing to receive counseling and to use condoms to avoid transmission of HIV
  • Expected to be available for the duration of participation and expected to comply with the visit schedule and other requirements as determined by the site investigator based on participant/parent/guardian report at entry
  • Not currently participating in another study of an investigational agent and is not expected to participate in any such study for the duration of participation, as determined by the site investigator based on participant/parent/guardian report at entry. Prior or current participation in the EIT/Tatelo, Moso, or BHP Adolescent cohort studies is permitted.
  • Willingness and ability to provide independent written informed consent for participation or parental/legal guardian is willing and able to provide written permission for child's participation and, child is willing and able to provide written assent for participation if 7-17 years of age
  • Previously entered the study in Step 1 or Step 3. All participants will enter Step 4 upon completing a prior study step. Participants ending Step 1a or Step 1b who, for any reason, do not proceed to Step 2 or to Step 3 will be eligible to proceed to Step 4. Participants ending Step 2 who, for any reason, do not proceed to Step 3 will be eligible to proceed to Step 4. Participants ending Step 3 for any reason will be eligible to proceed to Step 4.

Who cannot join

  • Active tuberculosis (either suspected or proven) or malignancy.
  • Hepatitis B surface antigen (HBsAg) positive
  • Received within 30 days prior to study entry, or is identified as requiring, any of the following:
  • Any immunoglobulin-based treatment
  • Chronic (more than 14 days) systemic steroid treatment
  • Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
  • For participants entering Step 1 and Step 2: <5 kg or >115kg.
  • For participants entering Step 3 directly: Received NNRTI-based ART (including efavirenz, nevirapine, rilpivirine) within 14 days of Step 3 entry

Trial locations and contacts

2 sites in 1 country.

Botswana2 sites

  • Francistown CRS (CRS #31891)

    Francistown

  • Botswana Harvard Health Partnership CRS (CRS #31833)

    Gaborone

Other trials in Botswana

About this study

Official title: Phase I/II Trial to Evaluate the Impact of Three Broadly Neutralizing Antibodies or Analytic Treatment Interruption on Viral Reservoir, Immune Function, and Maintenance of HIV Suppression in Early Treated Children in Botswana

The purpose of this study is to advance pediatric HIV treatment and cure research by evaluating the impact of a combination of three anti-HIV-1 broadly neutralizing antibodies (bNAbs) or analytic treatment interruption (ATI) on viral reservoir, immune function, and maintenance of HIV suppression in early-treated children.

Conditions
HIV, HIV Infections
Being tested
PGDM1400LS, VRC07-523LS, PGT121.414.LS, ART Regimen prior to enrolling in Step 1a, ART Regimen prior to enrolling in Step 1b
Medical subject headings
HIV Infections

What participants receive

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

  • PGDM1400LSDrug

    IV Antibody Infusion based on subject's weight

  • VRC07-523LSDrug

    IV Antibody Infusion based on subject's weight

  • PGT121.414.LSDrug

    IV Antibody Infusion based on subject's weight

  • ART Regimen prior to enrolling in Step 1aDrug

    Antiviral drugs are not study product. However, participants will continue to receive the ART regimen they were receiving prior to enrolling in the study during Step 1a.

  • ART Regimen prior to enrolling in Step 1bDrug

    Antiviral drugs are not study product. However, participants will continue to receive the ART regimen they were receiving prior to enrolling in the study during Step 1b.

  • Analytic Treatment InterruptionOther

    (all anti-HIV agents are discontinued)

Study groups in NCT06508749
Study groupRoleWhat they receive
Group 1-Step 1a EntryExperimentalReceiving PGDM1400LS first Step 1a includes a single-agent safety lead-in period for PGDM1400LS (Group 1), followed by three bNAbs administered on a rotating schedule while participants continue to receive ART. A pharmacokinetic assessment will be conducted for the three bNAbs.
Receives: Drug: PGDM1400LS; Drug: VRC07-523LS; Drug: PGT121.414.LS; Drug: ART Regimen prior to enrolling in Step 1a
Group 2-Step 1a EntryExperimentalReceiving PGT121.414.LS first Step 1a includes a single-agent safety lead-in period for PGT121.414.LS (Group 2), followed by three bNAbs administered on a rotating schedule while participants continue to receive ART. A pharmacokinetic assessment will be conducted for the three bNAbs.
Receives: Drug: PGDM1400LS; Drug: VRC07-523LS; Drug: PGT121.414.LS; Drug: ART Regimen prior to enrolling in Step 1a
Step 1b EntryExperimentalATI Only. For anyone directly enrolling in the Step 3 ATI and not participating in Steps 1 or 2 In Step 1b participants receive three bNAbs administered on a rotating schedule while continuing to receive ART.
Receives: Drug: PGDM1400LS; Drug: VRC07-523LS; Drug: PGT121.414.LS; Drug: ART Regimen prior to enrolling in Step 1b
Step 2aExperimentalIn Step 2a participants discontinue ART and receive three bNAbs administered on a rotating schedule.
Receives: Drug: PGDM1400LS; Drug: VRC07-523LS; Drug: PGT121.414.LS
Step 2bExperimentalIn Step 2b participants remain off ART and continue to receive three bNAbs administered on a rotating schedule.
Receives: Drug: PGDM1400LS; Drug: VRC07-523LS; Drug: PGT121.414.LS
Step 3 progressionExperimentalATI Only. Participants discontinue ART and bNAbs. For participants progressing to Step 3 after participating in Steps 1 and 2
Receives: Other: Analytic Treatment Interruption
Group 3- Step 3 Direct EntryExperimentalATI Only. Participants discontinue ART. For anyone directly enrolling in the Step 3 ATI and not participating in Steps 1 or 2
Receives: Other: Analytic Treatment Interruption

What is being measured

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

  1. To describe the safety and pharmacokinetics of bNAb immunotherapy with VRC07-523LS, PGDM1400LS and PGT121.414.LS when added to existing effective ART in early-treated children living with HIV-1 in Botswana

    Occurrence of Grade 3 or higher adverse events Occurrence of Grade 1 or higher bNAb-related adverse events Occurrence of any SAE Permanent discontinuation of study product Pre-dose trough concentrations of VRC07-523LS, PGDM1400LS and PGT121.414.LS at Week 16 Pre-dose trough concentrations of VRC07-523LS, PGDM1400LS and PGT121.414.LS through 32 weeks

    Measured: Through week 32

  2. To describe the safety of up to 24 weeks of bNAb immunotherapy with VRC07-523LS, PGDM1400LS and PGT121.414.LS when added on a rotating schedule to existing effective ART in early-treated children living with HIV-1 in Botswana

    Occurrence of Grade 3 or higher adverse events Occurrence of Grade 1 or higher bNAb-related adverse events Occurrence of any SAE Permanent discontinuation of study product

    Measured: Through week 24

  3. To determine the safety of 24 weeks of maintenance VRC07-523LS, PGDM1400LS and PGT121.414.LS immunotherapy alone, following the discontinuation of ART

    Occurrence of Grade 3 or higher adverse events Occurrence of Grade 1 or higher bNAb-related adverse events

    Measured: Through Week 24

  4. To determine the maintenance of virologic suppression of 24 weeks of maintenance VRC07-523LS, PGDM1400LS and PGT121.414.LS immunotherapy alone, following the discontinuation of ART

    Viral rebound defined as plasma HIV-1 RNA ≥400 copies/mL at or prior to 24 weeks of bNAb-only treatment.

    Measured: Through Week 24

  5. To determine the CD4 cell count preservation of 24 weeks of maintenance VRC07-523LS, PGDM1400LS and PGT121.414.LS immunotherapy alone, following the discontinuation of ART

    Change in absolute CD4 cell count

    Measured: Through Week 24

  6. To describe the safety, maintenance of virologic suppression, and CD4 cell count preservation of up to 48 weeks of ATI (with no ART or bNAbs) among participants who meet specified criteria for an ATI

    Occurrence of Grade 3 or higher adverse events Occurrence of Grade 1 or higher ATI-related adverse events Viral rebound defined as plasma HIV-1 RNA ≥400 copies/mL at or prior to 48 weeks of ATI Change in absolute CD4 cell count

    Measured: Through Week 48

Secondary outcomes (3)

  1. To measure the proportion of participants with viral rebound defined as a single plasma HIV-1 RNA ≥400 copies/mL at or prior to 48 weeks of bNAb-only treatment (for those who continue bNAb-only treatment beyond 24 weeks)

    Viral rebound defined as plasma HIV-1 RNA ≥400 copies/mL at or prior to 48 weeks of bNAb-only treatment (among participants who continue beyond 24 weeks on bNAb-only treatment)

    Measured: Through week 48

  2. To monitor and report time to re-suppression of plasma HIV-1 RNA following re-initiation of ART, for participants who experience viral rebound on bNAbs alone or during ATI

    Time to viral re-suppression defined as first HIV-1 RNA <40 copies/mL following ART resumption

    Measured: Through week 48

  3. To measure the size of residual viral reservoirs, during each step of the study. Comparisons will include change during triple bNAbs + ART; change during triple bNAbs alone; change during ATI; and change during entire study

    Change in total, intact, and defective provirus between entry and end of triple bNAbs + ART Change in total, intact, and defective provirus between start of bNAb-only treatment and end of bNAb-only treatment Change in total, intact, and defective provirus between start of ATI and end of ATI.

    Change in total, intact, and defective provirus between study entry and end of ATI.

    Measured: Through week 48

Timeline

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

  1. First posted18 Jul 2024
  2. Study start11 Nov 2024
  3. Primary completion3 Sep 2027 (estimated)
  4. Study completion18 Feb 2028 (estimated)

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06508749
Sponsor's protocol ID
IMPAACT 2042
Status last verified
Sep 2026
First submitted
26 Jun 2024
Last updated
10 Sep 2026
Results posted
No
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 1/2 study testing PGDM1400LS, VRC07-523LS and PGT121.414.LS in people with HIV and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Botswana.

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 55 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

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?

To describe the safety and pharmacokinetics of bNAb immunotherapy with VRC07-523LS, PGDM1400LS and PGT121.414.LS when added to existing effective ART in early-treated children living with HIV-1 in Botswana (time frame: Through week 32). The study lists 6 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 NCT06508749.

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 10 Sep 2026.

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The Tatelo Plus Study (NCT06508749) | AzTrials