Phase 2 HIV and AIDS Trial, Recruiting NCT01419561 Sponsor: National Cancer Institute (NCI) Condition: HIV and AIDS
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Phase 2 HIV and AIDS Trial, Recruiting

NCT01419561
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:

  • People aged 18 or older
  • People with any HIV status (either HIV positive or HIV negative)
  • People who have at least two symptoms, lab results, or scan findings from at least two different categories that may be linked to a condition called KICS (Kaposi sarcoma herpesvirus inflammatory cytokine syndrome), and that cannot be easily explained by another known medical condition. These categories include:
    • Symptoms (such as fever above 38°C, chills, fatigue, fluid swelling, cough, shortness of breath, nausea, loss of appetite, abdominal pain, joint or muscle pain, confusion, or nerve pain)
    • Abnormal blood test results (such as low red blood cells, low platelets, low white blood cells, low protein levels, low sodium, or abnormal blood clotting)
    • Abnormal scan findings (such as enlarged lymph nodes, an enlarged spleen or liver, or fluid buildup in body cavities not caused by certain specific lymphoma-related conditions)
  • People with a C-reactive protein (CRP) blood level above 3mg/L — this is a marker of inflammation measured by a blood test
  • People who have a known risk of exposure to a virus called KSHV (for example, people who are first or second generation immigrants from a region where KSHV is common, or men who have sex with men), OR people who have laboratory or tissue evidence confirming KSHV infection, OR people with a confirmed KSHV-related cancer such as Kaposi sarcoma or primary effusion lymphoma
  • Women who could become pregnant and men must agree to use reliable contraception during and after the study period, as required by the study drugs. If a woman becomes pregnant or suspects pregnancy during the study, the treating doctor must be informed immediately

Who may not be able to join:

  • People who have a confirmed diagnosis of a condition called KSHV-associated Multicentric Castleman Disease (MCD), proven by biopsy and confirmed by a specific pathology laboratory (including a newly recognised form where MCD-like cells are found in fluid or blood rather than tissue)
  • People who are pregnant
  • People who have a severe (Grade 4) medical abnormality that is unrelated to HIV, HIV treatment, or KICS, and that would prevent them from safely receiving any of the study treatments or being safely monitored
  • People who have any other condition or circumstances that, in the opinion of the research team, would make joining the study unsafe or unsuitable for that individual

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 9 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: Robert Yarchoan, M.D., National Cancer Institute (NCI)

Phone: (240) 760-6074

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
8 September 2011
Est. completion
31 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Natural history of KICS

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: 9 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