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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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-treatment control among treatment-naïve acute HIV-infected adults.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yongtao Sun, MD, PhD
• Collaborators: Beijing YouAn Hospital; China Medical University, China; First Affiliated Hospital of Guangxi Medical University; Guangxi Medical University; National Center for AIDS/STD Control and Prevention, China CDC; Shandong Province Centers for Disease Control and Prevention; Tang-Du Hospital; Tangdu Hospital, the Fourth Military Medical University; Zhejiang University
• Treatments: Lamivudine; Lopinavir; Ritonavir; Tenofovir; Zidovudine

Criteria

Inclusion Criteria:

1. Diagnosis of acute HIV infection (meets one of following criteria)

1. Negative for anti-HIV test formerly, but with an anti-HIV serological conversion within 6 months

2. Detection of plasma HIV RNA by RT-PCR in the absence of HIV antibody

3. Low-level of anti-HIV for BED HIV-1 capture enzyme immuno assay (BED-CEIA), optical density (OD)<0.6, only for B subtype)

4. Uncertain for an anti-HIV test, with an increasing anti-HIV level for repeated test within two weeks

5. 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

2. Ability, willingness to give informed consent

3. Able, willing to adhere to therapy and adherent to ART

4. Able, willing to comply with time requirements for study visits and evaluations

Exclusion Criteria:

1. Chronic HIV - 1 infection

2. Any evidence of an active AIDS-defining opportunistic infection

3. 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

4. A personal history of clinically significant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de points

5. History of chronic kidney disease

6. History of malignancy or transplantation, including skin cancers or Kaposi sarcoma

7. History of Severe peptic ulcer

8. History of alcoholism and drug abuse

9. Receipt of immunomodulating agents, immunization or systemic chemotherapeutic agents within 28 days prior to screening

10. 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

11. Have contraindications to cART

12. Other condition that does not fit to participate in this study