Phase 2 HIV and AIDS Trial, Recruiting NCT05470491 Sponsor: National Cancer Institute (NCI) Condition: HIV and AIDS
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Phase 2 HIV and AIDS Trial, Recruiting

NCT05470491
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial (recipients/patients):

  • People who have a blood cancer that has been confirmed by laboratory testing and that doctors consider appropriate for a stem cell transplant from a related donor, including certain types of leukemia, lymphoma, myeloma, or related blood conditions (confirm with trial site for your specific diagnosis and whether your disease is at the right stage)
  • People living with HIV whose HIV levels are kept very low (under 400 copies/mL) by a stable anti-HIV medication regimen, and whose medication regimen meets specific requirements depending on which dose group they are assigned to
  • People aged 18 or older
  • People who have at least one close biological relative (such as a parent, child, or sibling) who is a partial tissue-type match and willing to donate
  • People with a general health and activity level rated at 50% or above on a standard medical scale (meaning able to care for themselves, though may need occasional help)
  • People whose heart is pumping adequately (at least 40% efficiency on an ultrasound test)
  • People whose lungs are functioning adequately (meeting minimum thresholds on breathing tests, or showing no breathing problems at rest if testing is not possible)
  • People whose liver is functioning adequately, based on specific blood test results being within acceptable ranges
  • People whose kidneys are filtering at an adequate rate, based on a standard blood test
  • People who are able to understand the study and are willing to sign a consent form
  • People of childbearing potential, or those who can father children, who agree to use reliable contraception before joining and for at least one year after the transplant

Who may not be able to join (recipients/patients):

  • People currently taking part in another experimental treatment study, unless that treatment can be stopped or completed at least two weeks before the conditioning process begins
  • People whose blood cancer is not well enough controlled — for example, leukemia that has not reached remission, lymphoma that has not responded to treatment, or myeloma that has not reached complete remission
  • People with a serious ongoing illness that, in the lead doctor's opinion, would make a transplant unsafe
  • People for whom the study team cannot find a suitable anti-HIV medication plan that keeps the HIV virus sufficiently suppressed and is compatible with the study drugs
  • People who are currently pregnant
  • People who are breastfeeding and are not willing to stop before treatment begins on day 14 of the study schedule
  • People with a serious allergy to any of the medications used in this study (including certain immune-suppressing drugs, chemotherapy agents, and other study medications)
  • People for whom a central intravenous line (a type of tube placed in a large vein, needed for transplant) cannot be safely placed
  • People with an active psychiatric condition that the lead doctor believes would significantly affect their ability to follow the transplant plan and HIV medication schedule
  • People with severe nerve damage affecting movement or sensation (grade 3–4 on a standard medical scale)

Who might be able to join this trial (related donors):

  • Related donors aged 12 or older who are considered medically suitable and willing to donate, following the transplant centre's standard evaluation process, and who are also willing to provide blood and/or stem cell samples for research purposes
  • People (or their parent or legal guardian, if applicable) who are able to understand the study and are willing to sign a consent form

Who may not be able to join (related donors):

  • People who do not meet the transplant centre's standard requirements for donors

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mustafa A Hyder, M.D., National Cancer Institute (NCI)

Phone: (301) 402-0300

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
26 January 2023
Est. completion
30 July 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

In phase II, avoidance rate of grade III-IV acute GVHD at day +100; Determine a safe and recommended phase II dose level regimen

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov