Status:
UNKNOWN
Early cART and cART in Combination With Autologous HIV-1 Specific Cytotoxic T Lymphocyte (CTL) Infusion in The Treatment of Acute HIV-1 Infected Adults
Lead Sponsor:
Yongtao Sun, MD, PhD
Collaborating Sponsors:
Tang-Du Hospital
National Center for AIDS/STD Control and Prevention, China CDC
Conditions:
Acute HIV Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the ability of the early initiation of cART or cART in combination with autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion to achieve a post-treatme...
Detailed Description
Although combined antiretroviral therapy (cART) can suppress HIV-1 replication to a very low level in the blood, but it cannot eliminate latent viral reservoirs, and need lifelong adherence to expensi...
Eligibility Criteria
Inclusion
- Diagnosis of acute HIV infection (meets one of following criteria)
- Negative for anti-HIV test formerly, but with an anti-HIV serological conversion within 6 months
- Detection of plasma HIV RNA by RT-PCR in the absence of HIV antibody
- Low-level of anti-HIV for BED HIV-1 capture enzyme immuno assay (BED-CEIA), optical density (OD)\<0.6, only for B subtype)
- Uncertain for an anti-HIV test, with an increasing anti-HIV level for repeated test within two weeks
- A patient with a report of recent risk behavior in association with symptoms and signs of the acute retroviral syndrome, as well as a positive for HIV antigen detection and less than 4 bands in a Western blot assay
- Ability, willingness to give informed consent
- Able, willing to adhere to therapy and adherent to ART
- Able, willing to comply with time requirements for study visits and evaluations
Exclusion
- Chronic HIV - 1 infection
- Any evidence of an active AIDS-defining opportunistic infection
- Screening detects the following results:HGB\<90g/L、WBC\< 2 x 10E9/L、PLT\< 75 x 10E9/L、hemodiastase\>2 x ULN、Scr\>1.5 x ULN、ALT/AST/ALP\> 3 xULN、TbiL\>2 xULN、CK\>2 xULN、CCr\<60ml/min
- A personal history of clinically significant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de points
- History of chronic kidney disease
- History of malignancy or transplantation, including skin cancers or Kaposi sarcoma
- History of Severe peptic ulcer
- History of alcoholism and drug abuse
- Receipt of immunomodulating agents, immunization or systemic chemotherapeutic agents within 28 days prior to screening
- Women who are pregnant or breastfeeding, or with a positive pregnancy test during screening or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period
- Have contraindications to cART
- Other condition that does not fit to participate in this study
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02231281
Start Date
August 1 2014
End Date
December 1 2018
Last Update
April 26 2018
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China
2
National Center for STD and AIDS Control and Prevention, Chinese Center for Disease Control and Prevention
Beijing, Beijing Municipality, China
3
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
4
China Medical University
Shenyang, Liaoning, China