CompletedPhase 1/2

CCR5-modified CD4+ T Cells for HIV Infection

United States30 participantsStarted 2019-06-12

Plain-language summary

A Comparative Study of Autologous CD4+ T Cells Genetically Modified at the CCR5 Gene by Zinc Finger Nucleases SB-728 versus ex vivo Expanded Unmodified Autologous CD4+ T Cells in Treated HIV-1 Infected Subjects

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent signed and dated by study subject.
. Men or women, including trans men or women, ≥18 and ≤70 years of age.
. For persons born male who have not been surgically sterilized, willingness to abstain from sexual activity that could result in conception for 90 days after the cyclophosphamide administration visit.
. HIV-1 infection, documented by any FDA-approved ELISA, EIA, or rapid antibody detection method, and confirmed by a second FDA-approved antibody-based test or by a positive FDA-approved HIV RNA detection assay. FDA-approved HIV-1 RNA detection assay alone constitutes proof of HIV-1 infection assuming there is documentation of \>199 copies/mL of HIV-1 RNA in the absence of antiretroviral therapy.
. Adequate venous access for leukapheresis, as documented by standard clinical procedures at each site.
. The following laboratory values at screening:
. Absolute neutrophil count (ANC) \> 1500/mm3
. Hemoglobin level ≥11 g/dL

Exclusion criteria

. Women and persons born female regardless of gender identity with childbearing potential. These participants are considered to be of childbearing potential if they are postmenarchial, have an intact uterus and at least one ovary, and have had at least one menstrual period in the past two years. Participants who have had a documented bilateral tubal ligation or a hysterectomy are not considered to be of childbearing potential.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in the magnitude of change in intact provirus from before infusion to 96 weeks after infusion between the two study arms.

Timeframe: 96 weeks

Difference in the proportion of participants who experience a grade ≥3 adverse event that is considered possibly, probably, or definitely related to study treatment between the two study arms.

Timeframe: 96 weeks

Proportion of participants who experience a grade ≥3 adverse event that is considered possibly, probably, or definitely related to study treatment in each of the study arms.

Timeframe: 24 months

Trial details

NCT IDNCT03666871

SponsorUniversity of Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-31

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Written informed consent signed and dated by study subject.
. Men or women, including trans men or women, ≥18 and ≤70 years of age.
. For persons born male who have not been surgically sterilized, willingness to abstain from sexual activity that could result in conception for 90 days after the cyclophosphamide administration visit.
. HIV-1 infection, documented by any FDA-approved ELISA, EIA, or rapid antibody detection method, and confirmed by a second FDA-approved antibody-based test or by a positive FDA-approved HIV RNA detection assay. FDA-approved HIV-1 RNA detection assay alone constitutes proof of HIV-1 infection assuming there is documentation of \>199 copies/mL of HIV-1 RNA in the absence of antiretroviral therapy.
. Adequate venous access for leukapheresis, as documented by standard clinical procedures at each site.
. The following laboratory values at screening:
. Absolute neutrophil count (ANC) \> 1500/mm3
. Hemoglobin level ≥11 g/dL

Exclusion criteria

. Women and persons born female regardless of gender identity with childbearing potential. These participants are considered to be of childbearing potential if they are postmenarchial, have an intact uterus and at least one ovary, and have had at least one menstrual period in the past two years. Participants who have had a documented bilateral tubal ligation or a hysterectomy are not considered to be of childbearing potential.

What they're measuring

Difference in the magnitude of change in intact provirus from before infusion to 96 weeks after infusion between the two study arms.

Timeframe: 96 weeks

Difference in the proportion of participants who experience a grade ≥3 adverse event that is considered possibly, probably, or definitely related to study treatment between the two study arms.

Timeframe: 96 weeks

Proportion of participants who experience a grade ≥3 adverse event that is considered possibly, probably, or definitely related to study treatment in each of the study arms.

Timeframe: 24 months