Suspended

A Pilot Study of HIV Specific Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients With CD4+ T Cells 100-350 Cells/mm3

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections+11

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

With lower CD4 counts, HIV-infected patients may not be able to produce dendritic cells and lymphocytes, special types of immune cells that generate HIV-specific CTLs. Infusion of CTLs generated from the dendritic cells and lymphocytes of an HIV-negative sibling may enable the body to recognize HIV more readily and increase immune response against the virus. Dendritic cells and lymphocytes are obtained from an HIV-negative sibling. HIV-specific CTLs are generated from these cells and then infused into the HIV-infected patient monthly for 6 months. Siblings must be able to donate on multiple occasions, and patients are followed every 2-4 weeks during the study. Patients are screened over 3 months prior to study entry.

Official TitleA Pilot Study of HIV Specific Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients With CD4+ T Cells 100-350 Cells/mm3
NCT00000824
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralHIV InfectionsLentivirus Infections

Criteria

Inclusion Criteria Patients must have: * HLA A2+. * Other HLA matching with sibling. * CD4 count 100-350 cells/mm3. * No active opportunistic infection or malignancy (other than cutaneous Kaposi's sarcoma). * Current stable antiviral regimen. * Normal lab values and chest x-ray. Donor siblings must have: * HLA A2+. * HIV negativity. * Good venous access. * Ability to donate on multiple occasions. * Negative status for hepatitis B and C. Exclusion Criteria Concurrent Medication: Excluded: * Immunomodulators. * Cytokines. * Systemic steroids. * IV pentamidine. * Investigational drugs.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Stanford Univ School of Medicine

Stanford, United StatesOpen Stanford Univ School of Medicine in Google Maps
SuspendedOne Study Center
A Pilot Study of HIV Specific Cytotoxic T Lymphocyte (CTL) Therapy in HIV-Infected Patients With CD4+ T Cells 100-350 Cells/mm3 | PatLynk