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Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T

A Phase I, Open-Label Study to Assess the Effect of Escalating Doses of Cyclophosphamide on the Engraftment of SB-728-T in Aviremic HIV-Infected Subjects on HAART

NCT01543152•Sangamo Therapeutics

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate the safety, tolerability and effect on HIV viral load, of escalating doses of cyclophosphamide administered 1 day prior to SB-728-T infusion.

Detailed Description

The objectives of the study are to augment HIV-specific T-cells and to reverse or decrease the progressive destruction of CD4+ T-cells that leads to clinical AIDS. Levels of engraftment vary from negligible to about 10% of the CD4+ T-cells in the vascular compartment. Preliminary analyses of HAART TI suggest that an anti-HIV effect may correlate with the level of SB-728-T engraftment. Concurrently, non-myeloablative lymphodepletion with cyclophosphamide has been demonstrated to enhance engraftment of adoptively transferred T-cells through a variety of mechanisms. The study is being undertaken to increase SB-728-T engraftment through the administration of low non-myeloablative doses of cyclophosphamide.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female, 18 years of age or older with documented HIV diagnosis within 10 years of screening.
•Must be willing to comply with study-mandated evaluations; including discontinuation of current antiretroviral therapy during the treatment interruption.
•Must have received at least 6 months of continuous HAART therapy and have had undetectable VLs for the preceding 3 months.
•On stable antiretroviral medication (no changes to treatment within 4 weeks of screening.
•CD4+ T-cell count ≥500 cells/µL.
•Undetectable HIV-1 RNA obtained at screening.
•ANC ≥2500/µL
•Platelet count ≥200,000/µL

Exclusion Criteria

•Acute or chronic hepatitis B or hepatitis C infection.
•Active or recent (in prior 6 months) AIDS defining complication.
•Any cancer or malignancy within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin or low grade (0 or 1) anal or cervical dysplasia.
•Current diagnosis of NYHA grade 3 or 4 CHF, uncontrolled angina or arrhythmias.
•History or any features on physical examination indicative of a bleeding diathesis.
•Received HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector.
•Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents within 30 days prior to screening.
•Use of Aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2 week period prior to leukapheresis.
•Currently participating in another clinical trial or participation in such a trial within 30 days prior to screening visit.
•Subjects who are currently taking maraviroc or have received maraviroc within 6 months prior to screening.

Locations (11)

UCLA Care Center

Los Angeles, California, United States

Quest Clinical Research

San Francisco, California, United States

Circle CARE Center, LLC

Norwalk, Connecticut, United States

Orlando Immunology Center

Orlando, Florida, United States

Central West Clinical Research, Inc.

St Louis, Missouri, United States

Southwest CARE Center

Santa Fe, New Mexico, United States

Ricky K Hsu, MD, PC

New York, New York, United States

Central Texas Clinical Research

Austin, Texas, United States

North Texas Infectious Diseases Consultants

Dallas, Texas, United States

Gordon Crofoot, MD, PA

Houston, Texas, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

July 7, 2017

Completion Date

July 7, 2017

Last Updated

May 24, 2021

Enrollment

ACTUAL participants

Conditions

HIV

Interventions

SB-728-T

GENETIC

SB-728-T

GENETIC

SB-728-T

GENETIC

SB-728-T

GENETIC

SB-728-T

GENETIC

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

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RECRUITINGPHASE3

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

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RECRUITINGPHASE2

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T

Inclusion Criteria

Exclusion Criteria

Thinking and Memory Problems in People With HIV

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption