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Acute HIV InfectionPhase 3NCT02231281

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

A Phase 3 study testing cART(TDF/AZT+3TC+LPV/r) and CTL infusion in people with Acute HIV Infection, run by Yongtao Sun, MD, PhD at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute HIV Infection
What is being tested?
cART(TDF/AZT+3TC+LPV/r) and CTL infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
7 sitesChina
Study dates
Aug 2014to Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing You'an Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • National Center for STD and AIDS Control and Prevention, Chinese Center for Disease Control and Prevention

    Beijing, Beijing Municipality

  • Zhejiang University

    Hangzhou, Zhejiang

  • Shandong Center for Disease Control and Prevention

    Jinan, Shandong

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • China Medical University

    Shenyang, Liaoning

  • Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical Universit

    Xi'an, Shaanxi, 710038

Other trials in China

About this study

Official title: A Randomized, Open-label Trial to Compare the Efficacy and Safety of Early Initiation of cART With or Without Autologous HIV-1 Specific Cytotoxic T Lymphocyte (CTL) Infusion in Treatment-Naïve Acute HIV-1 Infected Adults

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.

Read the 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 expensive regimens that have potential side effects. Increasing evidence indicates that early antiretroviral therapy for recently HIV-infected patients results in slower progression of HIV disease and represent a unique opportunity to interfere with either the quantities or qualities of persistent reservoirs of replication-competent virus. However, the time course before the interruption of cART is unclear. This study will compare the virological and immunological outcomes and HIV latency of recently infected adults who receive cART or cART in combination with autologous HIV-1 CTL infusion for different periods.

The study will last 120 weeks. Participants will be randomly assigned to either the cART or the cART plus autologous HIV-1 CTL infusion arm of one of three cohorts. The three cohorts will differ in the period of cART given. Cohort 1, Cohort 2 or Cohort 3 will receive cART (Zidovudine (AZT)/Tenofovir disoproxil fumarate (TDF) +Lamivudine (3TC） + Lopinavir / Ritonavir （LPV/r)） for 48, 72 or 96 weeks, respectively. After 48, 72 or 96 weeks, cART will be interrupted respectively. Study visits will occur at study entry, Week 4 and 12, and every 12 weeks thereafter through treatment interruption, then every 4 weeks through 12 weeks later, then every 12 weeks through Week 120. At each study visit, a physical exam, blood collection, and completion of an adherence questionnaire will occur. Clinical, virological, and immunological evaluations and HIV latency examination will be performed at most study visit.

Being tested
cART(TDF/AZT+3TC+LPV/r), CTL infusion
Keywords
HIV Infections, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndromes, Immune System Diseases, Lentivirus Infections, Retroviridae Infections, Virus Diseases, RNA Virus Infections, Sexually Transmitted Diseases, Viral, Slow Virus Diseases, Therapeutic Uses, Pharmacologic Actions, Antiretroviral therapy, Early therapy
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, Immunologic Deficiency Syndromes, Immune System Diseases, Lentivirus Infections, Retroviridae Infections, Virus Diseases, RNA Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cART(TDF/AZT+3TC+LPV/r)Drug

    Also called Tenofovir Disoproxil Fumarate, Zidovudine, Lamivudine, Lopinavir/ritonavir (Kaletra)

    Standard antiretroviral therapy for HIV infection

  • CTL infusionProcedure or surgery

    cART(TDF/AZT+3TC+LPV/r) plus autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion

Study groups in NCT02231281
Study groupRoleWhat they receive
cART(TDF/AZT+3TC+LPV/r)ExperimentalcART(TDF/AZT+3TC+LPV/r)
Receives: Drug: cART(TDF/AZT+3TC+LPV/r)
CTL infusionExperimentalcART plus autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion
Receives: Drug: cART(TDF/AZT+3TC+LPV/r); Procedure: CTL infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in HIV DNA quantification at the interruption of cART

    HIV DNA detection includes total HIV DNA, integrated HIV DNA , 2-long terminal repeat （LTR） HIV DNA in resting CD4+T cell subsets.

    Measured: 48 weeks for Cohort 1, 72 weeks for Cohort 2, 96 weeks for Cohort 3

  2. Number of patients who achieve virological remission

    Virological remission is defined as undetectable of plasma HIV RNA for 24 weeks after the interruption of cART.

    Measured: 72 weeks for Cohort 1, 96 weeks for Cohort 2, 120 weeks for Cohort 3

Secondary outcomes (4)

  1. Number of patients who occur any grade 3 or 4 (clinical or laboratory) adverse events

    Measured: 120 weeks

  2. Number of patients who need to initiate late treatment

    Late treatment is defined cART should be administered according to local HIV treatment guidelines.

    Measured: 120 weeks

  3. Time from cART interruption to virological relapse (plasma viral load more than 50 copies/mL)

    Measured: 120 weeks

  4. HIV-1 specific CD4+ and CD8+ T cell responses at week 120

    Measured: 120 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionAug 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02231281
Sponsor's protocol ID
2014ZX10001002-001
Other IDs
2014ZX10001002-001
Status last verified
Apr 2018
First submitted
26 Aug 2014
Last updated
26 Apr 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cART(TDF/AZT+3TC+LPV/r) and CTL infusion in people with Acute HIV Infection, run by Yongtao Sun, MD, PhD at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in HIV DNA quantification at the interruption of cART (time frame: 48 weeks for Cohort 1, 72 weeks for Cohort 2, 96 weeks for Cohort 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02231281.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.

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