Test Albuvirtide in Experienced Patients (TALENT)
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| ClinicalTrials.gov Identifier: NCT02369965 |
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Recruitment Status : Unknown
Verified February 2015 by Frontier Biotechnologies Inc..
Recruitment status was: Recruiting
First Posted : February 24, 2015
Last Update Posted : February 24, 2015
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Sponsor:
Frontier Biotechnologies Inc.
Information provided by (Responsible Party):
Frontier Biotechnologies Inc.
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Brief Summary:
The purpose of this study is to determine the efficacy and safety of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults who failed first-line antiretroviral therapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections AIDS | Drug: albuvirtide Drug: lopinavir-ritonavir Drug: tenofovir Drug: lamivudine | Phase 3 |
This is a 48-week, randomized, controlled, open-label, multicenter study of the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1 infected adults who are failing their first antiretroviral regimen and have HIV-1 RNA levels >= 1000 copies/mL at screening.
Subjects meeting inclusion criteria are randomized in a 1:1 ratio to receive either albuvirtide + lopinavir-ritonavir or lopinavir-ritonavir + TDF + 3TC. If TDF is used in the current regimen or genotypic resistance test shows primary mutation to TDF, zidovudine (AZT) or abacavir will be used. Albuvirtide will be given by weekly intravenous infusion and LPV/r will be given twice daily. The primary end point is the percentage of participants with HIV-1 RNA<50 copies/mL at Week 48, the secondary end points include the change of HIV-1 RNA from baseline through Week 48, the percentage of participants with HIV-1 RNA<400 copies/mL at Week 48, and the change of CD4 count from baseline through Week 48.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 420 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy and Safety of Albuvirtide Plus Lopinavir-ritonavir in HIV-1-infected Adults Failed Standard First-line ART Regimen |
| Study Start Date : | January 2014 |
| Estimated Primary Completion Date : | July 2016 |
| Estimated Study Completion Date : | December 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: albuvirtide, lopinavir-ritonavir
albuvirtide once a week and lopinavir-ritonavir twice daily for 48 weeks
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Drug: albuvirtide
albuvirtide 320mg administered intravenously once a week
Other Name: ABT Drug: lopinavir-ritonavir lopinavir-ritonavir 400/100mg administered orally twice daily
Other Names:
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Active Comparator: lopinavir-ritonavir,tenofovir,lamivudine
lopinavir-ritonavir twice daily, tenofovir once daily and lamivudine once daily for 48 weeks
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Drug: lopinavir-ritonavir
lopinavir-ritonavir 400/100mg administered orally twice daily
Other Names:
Drug: tenofovir tenofovir 300mg administered orally once daily
Other Name: TDF Drug: lamivudine lamivudine 300mg administered orally once daily
Other Name: 3TC |
Primary Outcome Measures :
- Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 [ Time Frame: week 48 ]
Secondary Outcome Measures :
- Change from baseline through Week 48 in HIV-1 RNA [ Time Frame: from baseline to 48 weeks ]
- Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 [ Time Frame: week 48 ]
- Change from baseline through Week 48 in CD4 count [ Time Frame: from baseline to 48 weeks ]
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| Ages Eligible for Study: | 16 Years to 60 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients aged 16 to 60 years old;
- Previously documented HIV infection on standard antibody-based test;
- Previous antiretroviral therapy (ART) with NRTIs/NNRTIs for more than 6 months;
- HIV RNA≥1000 copies/ml;
- In healthy condition by physical examination, biochemistry, hematology and urinalysis test,and electrocardiogram etc., without serious liver and renal damages;
- Fully understand the purpose, characteristics, procedures of the trial, and the potentially adverse events which might occur during study; willing and able to sign informed consent.
Exclusion Criteria:
- Patients with acute HIV infection,or with AIDS-related disease, such as severe opportunistic infection or tumors;
- Previously received any protease inhibitors, HIV fusion inhibitors, HIV vaccines, or received other investigational drugs within 3 months;
- Co-treatment against hepatitis virus;
- Having abnormal values at screening as follows: Hemoglobin<9g/dL, White blood count <2×10^9/L, Neutrophil <1×10^9/L, Platelet count <75×10^9/L, Aminopherase >3-fold upper limit of normal value, Total bilirubin >2-fold upper limit of normal value, Creatinine >upper limit of normal value, Creatine phosphokinase >2-fold upper limit of normal value;
- With allergic constitution, or allergic history of the investigational drug and ART drugs;
- With serious chronic disease, metabolic disease (such as diabetes), mental disorder and nervous disease;
- Had a history of hemophilia A or B;
- Alcohol abuse or drug abuse;
- Pregnant women, breast feeding women, and women in child-bearing age disagreed with use of birth control;
- Unsuitable to participate in this study in the opinion of the site investigator.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369965
Contacts
| Contact: Cheng Yao | +86 025 87158168 | yaocheng@frontierbiotech.com |
Locations
| China, Beijing | |
| 302 Military Hospital of China | Recruiting |
| Beijing, Beijing, China | |
| Contact: Min Zhao | |
| Principal Investigator: Min Zhao | |
| Beijing Ditan Hospital, Capital medical university | Recruiting |
| Beijing, Beijing, China | |
| Contact: Hongxing Zhao | |
| Principal Investigator: Hongxing Zhao | |
| Beijing YouAn Hospital, Capital medical university | Recruiting |
| Beijing, Beijing, China | |
| Contact: Hao Wu | |
| Principal Investigator: Hao Wu | |
| China, Guangdong | |
| Guangzhou Eighth People's Hospital | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Weiping Cai | |
| Principal Investigator: Weiping Cai | |
| Shenzhen Third People's Hospital | Not yet recruiting |
| Shenzhen, Guangdong, China | |
| Contact: Hui Wang | |
| Principal Investigator: Hui Wang | |
| China, Henan | |
| Henan Infectious Disease Hospital | Recruiting |
| Zhengzhou, Henan, China | |
| Contact: Qingxia Zhao | |
| Principal Investigator: Qingxia Zhao | |
| China, Hunan | |
| The First Hospital of Changsha | Recruiting |
| Changsha, Hunan, China | |
| Contact: Min Wang | |
| Principal Investigator: Min Wang | |
| The Second Xiangya Hospital of Central South University | Not yet recruiting |
| Changsha, Hunan, China | |
| Contact: Yuhuang Zheng | |
| Principal Investigator: Yuhuang Zheng | |
| China, Liaoning | |
| Dalian Sixth People's Hospital | Not yet recruiting |
| Dalian, Liaoning, China | |
| Contact: Zhenxing Cui | |
| Principal Investigator: Zhenxing Cui | |
| China, Shanghai | |
| Shanghai Public Health Clinical Center | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: Hongzhou Lu | |
| Principal Investigator: Hongzhou Lu | |
| China, Shanxi | |
| Tangdu Hospital of the Forth Military Medical University | Recruiting |
| Xi'an, Shanxi, China | |
| Contact: Yongtao Sun | |
| Principal Investigator: Yongtao Sun | |
| China, Zhejiang | |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Not yet recruiting |
| Hangzhou, Zhejiang, China | |
| Contact: Jifang Sheng | |
| Principal Investigator: Jifang Sheng | |
Sponsors and Collaborators
Frontier Biotechnologies Inc.
Investigators
| Study Director: | Dong Xie | Frontier Biotechnologies Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Frontier Biotechnologies Inc. |
| ClinicalTrials.gov Identifier: | NCT02369965 |
| Other Study ID Numbers: |
FB-ABWT-Ⅲ-301 ChiCTR-TRC-14004276 ( Registry Identifier: Chinese Clinical Trial Registry ) |
| First Posted: | February 24, 2015 Key Record Dates |
| Last Update Posted: | February 24, 2015 |
| Last Verified: | February 2015 |
Keywords provided by Frontier Biotechnologies Inc.:
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HIV-1 AIDS Albuvirtide Treatment-experienced Fusion inhibitor |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Lopinavir Tenofovir Lamivudine |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |