HIV-1-infectionPhase 2ABLNCT03719664
Albuvirtide and 3BNC117 as Long-Acting Maintenance Therapy in Virologically Suppressed Subjects
A Phase 2 study testing Albuvirtide, 3BNC117 and Baseline ART in people with HIV-1-infection, run by Frontier Biotechnologies Inc. at 7 sites in United States.
Trial summary
The study is an adaptive, phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide (ABT) and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Albuvirtide, 3BNC117 and Baseline ART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesUnited States
- Study dates
- 17 Dec 2018to Dec 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential subjects are required to meet all of the following criteria for enrollment into the study.
- HIV-1 seropositive;
- Males and females, age ≥18 years;
- Receiving oral combination antiretroviral therapy for last 24 weeks;
- No change in antiretroviral regimen within last 4 weeks prior to Screening Visit and in-between Screening Visit and First Treatment Visit with an exception that subjects on NNRTI-containing regimens will be allowed to switch to protease inhibitor- or integrase strand transferase inhibitor-based regimens and such change, if needed, should occur at least 4 weeks prior to cessation of oral antiretroviral therapy;
- Subject has two or more potential alternative antiretroviral drug options available;
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- Plasma HIV-1 RNA <50 copies/mL at Screening Visit as determined by Human Immunodeficiency Virus 1 (HIV-1) Quantitative, RNA (Taqman® Real-Time PCR);
- No documented detectable viral loads (HIV-1 RNA > 50 copies/mL) within the last 24 weeks prior to Screening Visit. An exception for a recorded HIV-1 RNA "blip" (e.g., transient HIV-1 RNA <400 copies/mL) can be considered, although the preceding and following HIV-1 RNA measurements should be <50 copies/mL;
- CD4 cell count of >300 cells/mm3 at Screening Visit;
- Laboratory values at Screening:
- Absolute neutrophil count (ANC) ≥750/ mm3;
- Hemoglobin (Hb) ≥10.5 gm/dL (male) or ≥9.5 gm/dL (female);
- Platelets ≥75,000 /mm3;
- Serum alanine transaminase (SGPT/ALT) <1.25 x upper limit of normal (ULN);
- Serum aspartate transaminase (SGOT/AST) <1.25 x ULN;
- Serum total bilirubin within normal range; and
- Creatinine ≤1.5 x ULN.
- Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically significant by the Principal Investigator;
- Both male and female subjects and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized or who do not have sex with women). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug;
- Willing and able to participate in all aspects of the study, including use of intravenous medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.
- Note: Subjects diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychologic, or psychiatric) may be enrolled if in the opinion of site investigator these circumstances would not interfere with the subject's successful completion of the study requirements.
Who cannot join
- Potential subjects meeting any of the following criteria will be excluded from enrollment.
- Any active infection or malignancy requiring acute therapy;
- Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg);
- Hepatitis C infection as manifest by positive anti-HCV antibody and positive HCV RNA assay at the time of screening;
- Grade 4 DAIDS laboratory abnormality;
- Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study;
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- Unexplained fever or clinically significant illness within 1 week prior to the first study dose;
- Any vaccination within 2 weeks prior to the first study dose;
- Subjects weighing <35kg;
- History of anaphylaxis to any oral or parenteral drugs;
- Use of any fusion inhibitors and broadly neutralizing monoclonal antibody prior to the Screening Visit;
- Participation in an experimental drug trial(s) within 30 days of the Screening Visit;
- Any known allergy or antibodies to the study drug or excipients;
- Treatment with any of the following:
- Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit;
- Immunosuppressants or immunomodulating agents within 60 days prior to the screening visit; or
- Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic steroid therapy > 5 mg/day will be excluded with the following exception:
- Subjects on inhaled, nasal, or topical steroids will not be excluded.
- Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
ABT-3BNC117_201 Investigational Site
Atlanta, Georgia, 30312
- Recruiting
ABT-3BNC117_201 Investigational Site
Ft. Pierce, Florida, 34982
- Recruiting
ABT-3BNC117_201 Investigational Site
Hialeah, Florida, 33016
- Recruiting
ABT-3BNC117_201 Investigational Site
New York, New York, 10029
- Recruiting
ABT-3BNC117_201 Investigational Site
Orlando, Florida, 32803
- Recruiting
ABT-3BNC117_201 Investigational Site
Palm Springs, California, 92262
- Recruiting
ABT-3BNC117_201 Investigational Site
San Francisco, California, 94115
About this study
Official title: A Phase 2, Multicenter, Three-part Study to Establish the Dosage, Safety and Antiviral Activity of Combination Therapy With Albuvirtide and 3BNC117 as Long-Acting Maintenance Therapy in Virologically Suppressed Subjects With HIV-1 Infection
The study is an adaptive, phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide (ABT) and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection.
Read the detailed description
This is a three-part, multicenter study that will enroll a total of 80 eligible, HIV-1 subjects who are virologically suppressed and stable on daily oral combination antiretroviral therapy. The study will be conducted in three parts.
Part 1 and Part 2 are the dose-ranging portions of the study. In Part 1, 30 eligible subjects will be randomized in a 1:1:1 ratio to receive 16 weeks of combination treatment with albuvirtide and 3BNC117 or continue on the existing ART regimen under one of the three cohorts as follows:
- Cohort 1: albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks
- Cohort 2: albuvirtide 0.32 g and 3BNC117 2 g every 4 weeks
- Control Arm 1: Subjects continuing on baseline ART
In Part 2 of the study, 20 eligible subjects will be randomized in a 1:1 ratio to receive 16 weeks of combination treatment with albuvirtide and 3BNC117 under one of the two cohorts as follows:
- Cohort 3: albuvirtide 0.32 g and 3BNC117 0.8 g every 4 weeks
- Cohort 4: albuvirtide 0.16 g and 3BNC117 0.8 g every 4 weeks
Part 3 of this study will enroll an additional 30 subjects in a 2:1 ratio to receive up to 28 weeks of combination treatment with optimal dose of albuvirtide and 3BNC117 or continue on the existing ART regimen as follows:
- Optimal Dose: albuvirtide and 3BNC11 every 2 or 4 weeks
- Control Arm 2: Subjects continuing on baseline ART All consenting patients, in Cohort 1 and 2 (Part 1) and Cohort 3 and 4 (Part 2) of the study, will be shifted from daily oral combination antiretroviral regimen to an intravenous infusion of ABT and 3BNC117. The total treatmentduration with the ABT and 3BNC117 combination regimen will be up to 16 weeks (for Part 1 and Part 2) or 28 weeks (for Part 3) with a two week overlap of the baseline oral antiretroviral regimen and the ABT-3BNC117 combination regimen at the beginning of the study treatment and at the end of the treatment phase in subjects who do not experience virologic rebound. During the two week overlap of baseline oral antiretrovirals and ABT-3BNC117 combination regimen at the beginning of the study treatment, subject will receive weekly doses of ABT and 3BNC117 as intravenous infusions. Beyond the overlap period, subjects in Cohort 1 will receive study treatments every two weeks and subjects in Cohort 2, 3, and 4 will receive study treatments every four weeks.
Study participants will be monitored for viral rebound every two weeks following initiation of ABT-3BNC117 combination and will re-initiate an oral antiretroviral regimen if virologic rebound is confirmed with plasma HIV-1 RNA levels above 200 copies/ml on two consecutive blood draws.
Pharmacokinetics of ABT and 3BNC117 will be assessed in this study.
- Conditions
- HIV-1-infection
- Being tested
- Albuvirtide, 3BNC117, Baseline ART
- Keywords
- HIV-1, 3BNC117, Albuvirtide, Broadly neutralizing antibody, Long-Acting HIV-1 Fusion Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuvirtideDrug
Also called Fusion inhibitor
Intravenous infusion of Albuvirtide
3BNC117Drug
Also called Monoclonal antibody
Intravenous infusion of 3BNC117
Baseline ARTDrug
Also called ART
Subjects continuing on baseline ART
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: albuvirtide & 3BNC117 | Experimental | albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks Receives: Drug: Albuvirtide; Drug: 3BNC117 |
| Cohort 2: albuvirtide & 3BNC117 | Experimental | albuvirtide 0.32 g and 3BNC117 2 g every 4 weeks Receives: Drug: Albuvirtide; Drug: 3BNC117 |
| Control Arm 1: Baseline ART | Active comparator | Subjects continuing on baseline ART Receives: Drug: Baseline ART |
| Cohort 3: albuvirtide & 3BNC117 | Experimental | albuvirtide 0.32 g and 3BNC117 0.8 g every 4 weeks Receives: Drug: Albuvirtide; Drug: 3BNC117 |
| Cohort 4: albuvirtide & 3BNC117 | Experimental | albuvirtide 0.16 g and 3BNC117 0.8 g every 4 weeks Receives: Drug: Albuvirtide; Drug: 3BNC117 |
| Optimal Dose: albuvirtide & 3BNC117 | Experimental | albuvirtide and 3BNC117 every 2 or 4 weeks Receives: Drug: Albuvirtide; Drug: 3BNC117 |
| Control Arm 2: Baseline ART | Active comparator | Subjects continuing on baseline ART Receives: Drug: Baseline ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 3 of the study.
Measured: 28 weeks in Part 3
Secondary outcomes (10)
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 1 of the study
Measured: 16 weeks in Part 1
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 2 of the study
Measured: 16 weeks in Part 2
Time to virologic rebound after discontinuation of baseline ART regimen
Note: Virologic rebound is defined as two consecutive HIV-1 RNA levels of > 200 copies/ml.
Measured: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Proportion of participants achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
Measured: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Time to achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
Measured: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Mean change in HIV-1 RNA, at each visit within the treatment phase
Measured: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Mean change in CD4 cell count, at each visit within the treatment phase
Measured: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Mean change in CD4:CD8 ratio, at each visit within the treatment phase
Measured: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Emergence of new resistance mutations to antiretroviral drugs as evaluated by GenoSure Archive or PhenoSense GT Assay
Measured: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Measurement of treatment adherence to the ABT and 3BNC117 combination regimen
Measured: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start17 Dec 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frontier Biotechnologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frontier clinical team, Study director, Frontier Biotechnologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719664
- Sponsor's protocol ID
- ABT-3BNC117_201
- Acronym
- ABL
- Status last verified
- Sep 2021
- First submitted
- 22 Oct 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Three-part Study to Establish the Dosage, Safety and Antiviral Activity of Combination Therapy With Albuvirtide and 3BNC117 as Long-Acting Maintenance Therapy in Virologically Suppressed Subjects With HIV-1 Infection
- ClinicalTrials.gov ID
- NCT03719664
- Acronym / sponsor ID
- ABL / ABT-3BNC117_201
- Conditions
- HIV-1-infection
- Keywords
- HIV-1, 3BNC117, Albuvirtide, Broadly neutralizing antibody, Long-Acting HIV-1 Fusion Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Frontier Biotechnologies Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is an adaptive, phase 2, multicenter, three-part study to establish the dosage, safety and antiviral activity of combination therapy with albuvirtide (ABT) and 3BNC117 as long-acting maintenance therapy in virologically suppressed subjects with HIV-1 infection.
Detailed description
This is a three-part, multicenter study that will enroll a total of 80 eligible, HIV-1 subjects who are virologically suppressed and stable on daily oral combination antiretroviral therapy. The study will be conducted in three parts.
Part 1 and Part 2 are the dose-ranging portions of the study. In Part 1, 30 eligible subjects will be randomized in a 1:1:1 ratio to receive 16 weeks of combination treatment with albuvirtide and 3BNC117 or continue on the existing ART regimen under one of the three cohorts as follows:
- Cohort 1: albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks
- Cohort 2: albuvirtide 0.32 g and 3BNC117 2 g every 4 weeks
- Control Arm 1: Subjects continuing on baseline ART
In Part 2 of the study, 20 eligible subjects will be randomized in a 1:1 ratio to receive 16 weeks of combination treatment with albuvirtide and 3BNC117 under one of the two cohorts as follows:
- Cohort 3: albuvirtide 0.32 g and 3BNC117 0.8 g every 4 weeks
- Cohort 4: albuvirtide 0.16 g and 3BNC117 0.8 g every 4 weeks
Part 3 of this study will enroll an additional 30 subjects in a 2:1 ratio to receive up to 28 weeks of combination treatment with optimal dose of albuvirtide and 3BNC117 or continue on the existing ART regimen as follows:
- Optimal Dose: albuvirtide and 3BNC11 every 2 or 4 weeks
- Control Arm 2: Subjects continuing on baseline ART All consenting patients, in Cohort 1 and 2 (Part 1) and Cohort 3 and 4 (Part 2) of the study, will be shifted from daily oral combination antiretroviral regimen to an intravenous infusion of ABT and 3BNC117. The total treatmentduration with the ABT and 3BNC117 combination regimen will be up to 16 weeks (for Part 1 and Part 2) or 28 weeks (for Part 3) with a two week overlap of the baseline oral antiretroviral regimen and the ABT-3BNC117 combination regimen at the beginning of the study treatment and at the end of the treatment phase in subjects who do not experience virologic rebound. During the two week overlap of baseline oral antiretrovirals and ABT-3BNC117 combination regimen at the beginning of the study treatment, subject will receive weekly doses of ABT and 3BNC117 as intravenous infusions. Beyond the overlap period, subjects in Cohort 1 will receive study treatments every two weeks and subjects in Cohort 2, 3, and 4 will receive study treatments every four weeks.
Study participants will be monitored for viral rebound every two weeks following initiation of ABT-3BNC117 combination and will re-initiate an oral antiretroviral regimen if virologic rebound is confirmed with plasma HIV-1 RNA levels above 200 copies/ml on two consecutive blood draws.
Pharmacokinetics of ABT and 3BNC117 will be assessed in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: albuvirtide & 3BNC117 | Experimental | Drug: Albuvirtide, Drug: 3BNC117albuvirtide 0.32 g and 3BNC117 2 g every 2 weeks |
| Cohort 2: albuvirtide & 3BNC117 | Experimental | Drug: Albuvirtide, Drug: 3BNC117albuvirtide 0.32 g and 3BNC117 2 g every 4 weeks |
| Control Arm 1: Baseline ART | Active comparator | Drug: Baseline ARTSubjects continuing on baseline ART |
| Cohort 3: albuvirtide & 3BNC117 | Experimental | Drug: Albuvirtide, Drug: 3BNC117albuvirtide 0.32 g and 3BNC117 0.8 g every 4 weeks |
| Cohort 4: albuvirtide & 3BNC117 | Experimental | Drug: Albuvirtide, Drug: 3BNC117albuvirtide 0.16 g and 3BNC117 0.8 g every 4 weeks |
| Optimal Dose: albuvirtide & 3BNC117 | Experimental | Drug: Albuvirtide, Drug: 3BNC117albuvirtide and 3BNC117 every 2 or 4 weeks |
| Control Arm 2: Baseline ART | Active comparator | Drug: Baseline ARTSubjects continuing on baseline ART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Potential subjects are required to meet all of the following criteria for enrollment into the study.
- Note: Subjects diagnosed with either substance dependence or substance abuse or any history of a concomitant condition (e.g., medical, psychologic, or psychiatric) may be enrolled if in the opinion of site investigator these circumstances would not interfere with the subject's successful completion of the study requirements.
Key exclusion criteria (19 listed)
- Potential subjects meeting any of the following criteria will be excluded from enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlbuvirtideAlso: Fusion inhibitorIntravenous infusion of Albuvirtide | Drug | Cohort 1: albuvirtide & 3BNC117, Cohort 2: albuvirtide & 3BNC117, Cohort 3: albuvirtide & 3BNC117, Cohort 4: albuvirtide & 3BNC117, Optimal Dose: albuvirtide & 3BNC117 |
| 3BNC117Also: Monoclonal antibodyIntravenous infusion of 3BNC117 | Drug | Cohort 1: albuvirtide & 3BNC117, Cohort 2: albuvirtide & 3BNC117, Cohort 3: albuvirtide & 3BNC117, Cohort 4: albuvirtide & 3BNC117, Optimal Dose: albuvirtide & 3BNC117 |
| Baseline ARTAlso: ARTSubjects continuing on baseline ART | Drug | Control Arm 1: Baseline ART, Control Arm 2: Baseline ART |
Primary outcome
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 3 of the study.
Time frame: 28 weeks in Part 3
10 secondary outcomes
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 1 of the study
Time frame: 16 weeks in Part 1
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 2 of the study
Time frame: 16 weeks in Part 2
Time to virologic rebound after discontinuation of baseline ART regimen
Time frame: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Proportion of participants achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
Time frame: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Time to achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
Time frame: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Mean change in HIV-1 RNA, at each visit within the treatment phase
Time frame: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Mean change in CD4 cell count, at each visit within the treatment phase
Time frame: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Mean change in CD4:CD8 ratio, at each visit within the treatment phase
Time frame: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Emergence of new resistance mutations to antiretroviral drugs as evaluated by GenoSure Archive or PhenoSense GT Assay
Time frame: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Measurement of treatment adherence to the ABT and 3BNC117 combination regimen
Time frame: 16 weeks in Part 1 and part 2, 28 weeks in part 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frontier clinical team study director
Frontier Biotechnologies Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albuvirtide, 3BNC117 and Baseline ART in people with HIV-1-infection, run by Frontier Biotechnologies Inc. at 7 sites in United States.
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 21 inclusion and 19 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 29 Sep 2021. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Cheng Yao, M.D. ((+86)025-69648387, yaocheng@frontierbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with HIV-1 RNA < 50 copies/mL at the end of treatment phase in Part 3 of the study. (time frame: 28 weeks in Part 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2021.