Safety and Efficacy of Allogenic Adoptive Immune Therapy for Immune Reconstitution in Chronic HIV-1 Infected Patients
1 other identifier
interventional
20
1 country
1
Brief Summary
Combination antiretroviral therapy (ART) effectively suppresses viral replication, leading to a significant immune recovery and a dramatic reduction in the incidence of AIDS-defining events. However, approximately 20% of individuals who exhibit stable viral suppression by ART, but fail to achieve sufficient immune reconstitution and are considered immune nonresponders (INRs). These INRs often experience an increased risk of opportunistic infections and shorter life expectancy compared with matched immune responders.Therefore, efficiently treating these immune nonresponders has become one of the most difficult challenges in the clinic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2016
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJune 19, 2019
May 1, 2019
4.8 years
September 8, 2015
June 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The changes of CD4 T cell counts
marker for host immunity
At Baseline and week 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Secondary Outcomes (3)
The changes of HIV-1 DNA
At Baseline and up to week 96
The ratio of CD4 and CD8 T cells
At Baseline and week 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
At Baseline and up to week 96
Study Arms (1)
Conventional plus AAIT
EXPERIMENTALParticipants will receive ART plus a dose of allogenic adoptive immune transfusion (3 times of MNCs transfusions) from day 0 through the week 2 study visit.
Interventions
Participants will receive ART and taken i.v., at a dose of 2-3\*10E8 MNCs/kg body at baseline, week 1 and 2.
Eligibility Criteria
You may qualify if:
- Immune non-responders with chronic HIV-1 infection
- Antiretroviral therapy (ART) for at least 24 months prior to study entry and continue within the 24 months after study entry
- CD4 count less than or equal to 200 cells/mm3 continuously and more than 50 cells/mm3 before entry and at screening, obtained within 30 days prior to study entry
- Viral load less than or equal to 50 copies/mL obtained within 12 months prior to study entry
- Certain specified laboratory values obtained within 30 days prior to study entry. More information on this criterion can be found in the study protocol
- Documentation that pre-entry specimen for the primary immune activation endpoint responses has been obtained
- No history of Centers for Disease Control and Prevention (CDC) category C AIDS-related opportunistic infections
- Karnofsky performance score greater than or equal to 70 within 30 days prior to study entry
- Ability and willingness to provide informed consent
You may not qualify if:
- Coinfection with other virus, including serum hepatitis C virus RNA positive, or one of followings are positive in anti-hepatitis A virus/anti-HDV/anti-hepatitis delta virus plus alanine aminotransferase (ALT) more than 80 IU/L
- History of combination with other severe diseases including renal, circulatory, respiratory, digestive, endocrine, neural and immunological diseases and tumors
- White blood cell (WBC) \<2.5\*10E9/L, platlet counts \<50\*10E9/L, Hb \<80g/L, lactate \>2 mmol/L
- Allergic constitution
- Pregnancy or lactation
- Accepting other immunomodulatory drugs within 6 months prior screening
- Drug addiction
- Other conditions possibly influencing the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing 302 hospital
Beijing, Beijing Municipality, 100069, China
Related Publications (3)
Zhang Z, Fu J, Xu X, Wang S, Xu R, Zhao M, Nie W, Wang X, Zhang J, Li T, Su L, Wang FS. Safety and immunological responses to human mesenchymal stem cell therapy in difficult-to-treat HIV-1-infected patients. AIDS. 2013 May 15;27(8):1283-93. doi: 10.1097/QAD.0b013e32835fab77.
PMID: 23925377BACKGROUNDHutter G. Stem cell transplantation in strategies for curing HIV/AIDS. AIDS Res Ther. 2016 Sep 13;13(1):31. doi: 10.1186/s12981-016-0114-y. eCollection 2016.
PMID: 27625700BACKGROUNDCorbeau P, Reynes J. Immune reconstitution under antiretroviral therapy: the new challenge in HIV-1 infection. Blood. 2011 May 26;117(21):5582-90. doi: 10.1182/blood-2010-12-322453. Epub 2011 Mar 14.
PMID: 21403129BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wang Fu-Sheng
Beijing 302 Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2015
First Posted
January 7, 2016
Study Start
October 1, 2016
Primary Completion
July 1, 2021
Study Completion
December 1, 2022
Last Updated
June 19, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share