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HIV InfectionsPhase 3TALENTNCT02369965

Test Albuvirtide in Experienced Patients

A Phase 3 study testing albuvirtide, lopinavir-ritonavir and tenofovir in people with HIV Infections and AIDS, run by Frontier Biotechnologies Inc. at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of albuvirtide combined with lopinavir-ritonavir (LPV/r) in HIV-1-infected patients who failed first-line antiretroviral therapy (ART). Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
HIV Infections, AIDS
What is being tested?
albuvirtide, lopinavir-ritonavir and tenofovir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
418 participants
Where
12 sitesChina
Study dates
19 Feb 2014to 2 Apr 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 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 16-60 years old, male or female.
  • Those who meet the Diagnostic Criteria of AIDS and HIV Infection, the Health Industry Standard of the People's Republic of China (WS 293-2008).
  • Those who have been undergoing antiretroviral treatment with nucleosides and non-nucleoside reverse transcriptase inhibitors (NRTIs+NNRTIs) for at least 6 months.
  • HIV-RNA ≥ 1000 copies/mL.
  • Those who have no serious hepatic or renal functional impairment and other parameters are generally in the normal ranges according to the comprehensive physical examinations (including general physical examination, routine blood and urine tests, blood chemistry tests, ECG, etc.).
  • The subjects should have a full understanding of the objective, nature, methods of the trial and the possible reactions. He/She should participate in the trial voluntarily and should sign the informed consent form.

Who cannot join

  • Those who are in an acute stage of infection, or have suffered from AIDS-related diseases (e.g. opportunistic infections or malignant tumors, etc.) at enrollment; or have suffered from opportunistic infections within 3 months prior to enrollment and the conditions have not reached a stable state within 2 weeks prior to enrollment.
  • Those who have used protease inhibitors or HIV fusion inhibitors for antiretroviral treatment, and who have participated in HIV vaccine clinical trials or have participated in other drug trials within recent 3 months.
  • Those who have been co-administered antiviral treatment for hepatitis.
  • Those whose screening test results meet one of the following: hemoglobin < 9 g/dL, WBC count <2×109/L, neutrophil count < 1×109/L, PLT count < 75×109/L, transaminase > 3×ULN, total bilirubin > 2×ULN, creatinine > 1×ULN, serum creatine phosphokinase > 2×ULN.
  • Those with allergic constitution or known allergic to ingredients of the investigational drug or ART drugs prescribed in the protocol.
  • Currently suffering from serious chronic diseases, metabolic diseases (such as diabetes mellitus), neurological and psychiatric disorders.
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  • Patients with hemophilia A or B.
  • Those with suspected or confirmed history of alcohol or drug abuse.
  • Pregnant or lactating women; or women of childbearing age who refuse to take contraceptive measures during the trial.
  • Those for whom the possibility of being enrolled is low according to the judgment of the investigator (e.g. weak physical condition, poor compliance, etc.).

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • 302 Hospital People's Liberation Army Of China

    Beijing, Beijing Municipality

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Beijing Youan Hospital, Capital medical university

    Beijing, Beijing Municipality

  • The First Hospital of Changsha

    Changsha, Hunan

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Guangzhou Eighth People's Hospital

    Guangzhou, Guangdong

  • Affiliated Hangzhou Xixi Hospital,Zhejiang University School Of Medicine

    Hangzhou, Zhejiang

  • The First Affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality

  • The Third People'S Hospital Of Shenzhen

    Shenzhen, Guangdong

  • Tangdu Hospital, Fourth Military Medical University

    Xi’an, Shanxi

  • Henan Infectious Disease Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Efficacy and Safety of Albuvirtide for Injection Combined With LPV/r for Treatment of HIV-1-Infected Patients Failed First-line Antiretroviral Therapy

The purpose of this study is to evaluate the efficacy and safety of albuvirtide combined with lopinavir-ritonavir (LPV/r) in HIV-1-infected patients who failed first-line antiretroviral therapy (ART).

Read the detailed description

This was a 48-week, multi-center, open-label, randomized and controlled, non-inferiority phase 3 clinical trial to evaluate the safety and efficacy of albuvirtide combined with LPV/r in HIV-1 infected patients who failed their first-line ART and had HIV-1 RNA levels ≥ 1000 copies/mL at screening.

The trial was conducted in 12 sites in China. Subjects meeting inclusion criteria were randomized in a 1:1 ratio to ABT group and NRTI group, in which the ABT group received albuvirtide and LPV/r combination therapy, and NRTI group received the standard 3-drug regimen of LPV/r + Lamivudine (3TC) + Tenofovir (TDF). If TDF was used in the previous regimen or genotypic resistance histories showed primary mutation to TDF, zidovudine (AZT) or abacavir (ABC) would be used. Albuvirtide was given by weekly intravenous infusion and LPV/r was given twice daily orally. A total of 418 subjects were randomized, of whom 401 received at least one treatment.

Conditions
HIV Infections, AIDS
Being tested
albuvirtide, lopinavir-ritonavir, tenofovir, lamivudine
Keywords
HIV-1, AIDS, Albuvirtide, Treatment-experienced, Fusion inhibitor
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

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

  • albuvirtideDrug

    Also called ABT

    albuvirtide 320mg administered intravenously once a week

  • lopinavir-ritonavirDrug

    Also called Kaletra, LPV/r

    lopinavir-ritonavir 400/100mg administered orally twice daily

  • tenofovirDrug

    Also called TDF

    tenofovir 300mg administered orally once daily

  • lamivudineDrug

    Also called 3TC

    lamivudine 300mg administered orally once daily

Study groups in NCT02369965
Study groupRoleWhat they receive
albuvirtide, lopinavir-ritonavirExperimentalalbuvirtide once a week and lopinavir-ritonavir twice daily for 48 weeks
Receives: Drug: albuvirtide; Drug: lopinavir-ritonavir
lopinavir-ritonavir,tenofovir,lamivudineActive comparatorlopinavir-ritonavir twice daily, tenofovir once daily and lamivudine once daily for 48 weeks
Receives: Drug: lopinavir-ritonavir; Drug: tenofovir; Drug: lamivudine

What is being measured

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

  1. Percentage of participants of virological suppression at Week 48

    Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48

    Measured: Through Week 48

Secondary outcomes (3)

  1. Changes of viral load

    Changes of HIV-1 RNA relative to baseline at Week 48

    Measured: Baseline to Week 48

  2. Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48

    Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48

    Measured: Through Week 48

  3. Changes of CD4 cell count

    Changes of CD4 cell count relative to baseline at Week 48

    Measured: Baseline to Week 48

Timeline

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

  1. First posted24 Feb 2015 (estimated)
  2. Study start19 Feb 2014
  3. Primary completion2 Apr 2018
  4. Study completion2 Apr 2018

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
418 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02369965
Sponsor's protocol ID
FB-ABWT-Ⅲ-301
Other IDs
ChiCTR-TRC-14004276
Acronym
TALENT
Status last verified
Sep 2021
First submitted
18 Feb 2015
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Su B, Yao C, Zhao QX, Cai WP, Wang M, Lu HZ, Chen YY, Liu L, Wang H, He Y, Zheng YH, Li LH, Chen JF, Yu JH, Zhu B, Zhao M, Sun YT, Lun WH, Xia W, Sun LJ, Dai LL, Jiang TY, Wang MX, Zheng QS, Peng HY, Wang Y, Lu RJ, Hu JH, Xing H, Shao YM, Xie D, Zhang T, Zhang FJ, Wu H; TALENT Study Team. Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1: interim analysis of the randomized, controlled, phase 3, non-inferiority TALENT study. Chin Med J (Engl). 2020 Nov 25;133(24):2919-2927. doi: 10.1097/CM9.0000000000001273.

    PubMed 33252379

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing albuvirtide, lopinavir-ritonavir and tenofovir in people with HIV Infections and AIDS, run by Frontier Biotechnologies Inc. at 12 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of participants of virological suppression at Week 48 (time frame: Through Week 48). 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 NCT02369965, which also lists 1 linked publication.

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 6 Oct 2021.

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