BridgeMD
New treatment option for HIV
Official title The Tatelo Plus Study
ClinicalTrials.gov ID: NCT06508749
What this study is testing
What is PGDM1400LS?
PGDM1400LS is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 24 to 25
You may be able to join if
- , Step 1
- 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...
- 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...
You likely can't join if
- 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...
See the full eligibility criteria
Who can join
- , Step 1
- 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...
- 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...
- 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...
- 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 , Step 2
- 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 , Step 3
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- For participants entering Step 1 and Step 2: \ 115kg.
- For participants entering Step 3 directly: Received NNRTI-based ART (including efavirenz, nevirapine, rilpivirine) within 14 days of Step 3 entry
The study team makes the final eligibility decision.
Where it's taking place
- Francistown, Botswana
- Gaborone, Botswana
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 24 weeks to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Francistown, Botswana; Gaborone, Botswana. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.