HIV-1-infectionPhase 2/3NCT02489461
Efficacy, Safety and Optimal Dose of VM-1500 in Comparison to Efavirenz Added to Standard-of-care Antiretroviral Therapy
A Phase 2/3 study testing VM-1500, Efavirenz and Antiretroviral therapy (ART) in people with HIV-1-infection, run by Viriom at 13 sites in Russia.
Trial summary
The study is conducted in two stages and open-label stage of the study. At the first stage of the study, the main purpose was to choose the optimal dose of VM-1500 (20 mg or 40 mg per day) in addition to standard-of-care basic antiretroviral therapy consisting of two NRTIs, in terms of reduction of viral load at Week… 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?
- VM-1500, Efavirenz and Antiretroviral therapy (ART)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 13 sitesRussia
- Study dates
- 5 Aug 2014to 18 Sep 2017
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Patient Information and Informed Consent Form.
- Males and females, age ≥ 18 years.
- HIV-1 infection, confirmed serologically in IFA or immunoblot analysis (or documented HIV-1 infection).
- Clinically stable HIV infection (clinical stages 1 or 2 according to the WHO classification).
- Indications (in the Investigator's opinion) for ART, according to the WHO Summary Guideline for use of antiretroviral drugs in HIV prevention and treatment (2013).
- HIV-1 RNA plasma level ≥ 5 000 copies/ml at screening.
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- СD4+ Т-cells number > 200 cells/mm3 at screening.
- Laboratory parameters as follows:
- White blood cells ≥ 2900/mm3 (2,9 x 109 cells/l) Absolute neutrophils ≥ 1500/mm3 (1,5 x 109 cells/l) Platelets ≥ 100000/mm3 (100 x 109 cells/l) Hemoglobin ≥ 9.0 g/dl Total bilirubin ≤ 1.5 x ULN AST and ALT≤ 2.5 x ULN Renal function GFR > 60 ml/min
Who cannot join
- Primary HIV-1 resistance to ART. Viral resistance mutations are defined as any basic mutations of resistance to NNRTIs, according to the updated list of VIH-1 resistance mutations (International AIDS society, 2013), associated with drug resistance in any genotype.
- History of antiretroviral therapy (ART), including for the prevention of vertical transmission of HIV.
- Acute hepatitis or hepatic cirrhosis of any etiology; anti-HCV antibodies or HBsAg at screening.
- Signs of acute infection or positive test result for syphilis, hepatitis A, Toxoplasma gondii, cytomegalovirus, gonorrhea, Chlamydia trachomatis during 30 days before screening.
- Opportunistic infections of the Category C (Centers of Disease Control (CDC), 2008), excluding Kaposi's sarcoma not requiring systemic therapy.
- History of tuberculosis of any localization, or tuberculosis at screening, according to x-ray examination.
- History of malignant tumors (except basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ, eliminated and cured ≥ 5 years ago).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Russia13 sites
Udmurtia Republican hospital for AIDS prevention
Izhevsk, Udmurtia Republic, 426067
Kaluga regional center for AIDS prevention
Kaluga, Kaluga Oblast
Republican hospital for AIDS prevention
Kazan', Tatarstan Republic, 420097
Lipetsk regional center for AIDS prevention
Lipetsk, Lipetsk Oblast, 398043
Central Scientific Research Institute of Epidemiology
Moscow, 105275
Moscow Infectional Clinical Hospital #2
Moscow, 105275
Moscow Prevention AIDS Center
Moscow, 129110
Perm Regional center for AIDS prevention
Perm, Perm Krai, 614088
Ryazan Regional Clinical Dermatovenerologic Dispensary
Ryazan, Ryazan Oblast, 390046
St.Petersburg city center for AIDS prevention
Saint Petersburg, 190103
Clinical infectious diseases hospital n.a. S.P. Botkin"
Saint Petersburg, 191167
City center for AIDS prevention
Tolyatti, Samara Oblast, 445846
Volgograd regional center for AIDS prevention
Volgograd, Volgograd Oblast, 400040
About this study
Official title: International, Multicenter, Randomized, Partially Blind Study to Evaluate Efficacy, Safety and Selection of the Optimal Dose for VM-1500 in Comparison to Efavirenz in Combination With Two NRTIs in Treatment-naïve, HIV-1 Infected Patients
The study is conducted in two stages and open-label stage of the study.
At the first stage of the study, the main purpose was to choose the optimal dose of VM-1500 (20 mg or 40 mg per day) in addition to standard-of-care basic antiretroviral therapy consisting of two NRTIs, in terms of reduction of viral load at Week 12 (<400 copies/ml) in treatment-naïve HIV-1-infected patients.
Read more
At the second stage of the study, the main purpose was to evaluate efficacy of VM- 1500 (in the optimal dose selected at the first stage of the study) in comparison to Efavirenz added to standard-of-care antiretroviral therapy of two NRTIs, in terms of reduction of viral load at Week 24 to the undetectable level (<50 copies/ml) in treatment-naïve HIV-1 infected patients.
Open-label stage of the study continued evaluation of viral load and immunological and safety parameters in HIV-1 patients receiving VM-1500 up to Week 96 and additional PK up to Week 100.
Read the detailed description
This project is an international, multicenter, randomized, partially blind clinical study to evaluate efficacy and safety of two different doses of VM-1500 in comparison with Efavirenz added to standard antiretroviral therapy including two NRTIs in treatment-naïve HIV-1-infected patients.
- Conditions
- HIV-1-infection
- Being tested
- VM-1500, Efavirenz, Antiretroviral therapy (ART)
- Keywords
- HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VM-1500Drug
Also called Elsulfavirine, Elpida®
VM-1500 up to 96 weeks
EfavirenzDrug
Also called Stocrin®
Efavirenz up to 48 weeks
Antiretroviral therapy (ART)Drug
Also called standard antiretroviral therapy of two NNRTIs
Antiretroviral therapy up to 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| VM-1500 20 mg + ART | Experimental | VM-1500 - 20 mg (Stage I), then optimal dose (Stage II and Open-Label Stage), ART Receives: Drug: VM-1500; Drug: Antiretroviral therapy (ART) |
| VM-1500 40 mg + ART | Experimental | VM-1500 - 40 mg (Stage I), then optimal dose (Stage II and Open-Label Stage), ART Receives: Drug: VM-1500; Drug: Antiretroviral therapy (ART) |
| Efavirenz 600 mg + ART | Active comparator | Efavirenz 600 mg (Stage I and Stage II), ART Receives: Drug: Efavirenz; Drug: Antiretroviral therapy (ART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of HIV-1 RNA level in blood plasma <400 copies/ml
Comparison of the percentage of patients with reduced viral load to < 400 copies/ml at Week 12 in VM-1500 20 mg, VM-1500 40 mg and Efavirenz treatment groups
Measured: 12 weeks
Secondary outcomes (5)
Reduction of HIV-1 RNA level in blood plasma <50 copies/ml
Comparison of the percentage of patients with reduced viral load to an undetectable level (< 50 copies/ml) at Week 24 in VM-1500 group with the selected dose and Efavirenz group.
Measured: 24 weeks
Reduction of HIV-1 RNA level in blood plasma <50 copies/ml
Comparison of the percentage of patients with reduced viral load to an undetectable level (< 50 copies/ml) at Week 48 in VM-1500 group with the selected dose and Efavirenz group.
Measured: 48 weeks
Change in the absolute CD4+ lymphocytes count
Change in the absolute CD4+ lymphocytes count from Baseline to Week 48 in VM-1500 group with the selected dose and Efavirenz group.
Measured: 48 weeks
Change in the absolute CD8+ lymphocytes count
Change in the absolute CD8+ lymphocytes count from Baseline to Week 48 in VM-1500 group with the selected dose and Efavirenz group.
Measured: 48 weeks
The percent of patients with study therapy-resistant HIV-1 development
The proportion of patients who develop study therapy-resistant HIV-1 from Baseline to Week 48 in VM-1500 group with the selected dose and Efavirenz group.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study start5 Aug 2014
- Primary completion5 Apr 2016
- Study completion18 Sep 2017
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viriom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irina Y Tyrnova, Study chair, Viriom,LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489461
- Sponsor's protocol ID
- HIV-VM1500-04
- Status last verified
- Sep 2018
- First submitted
- 18 Jun 2015
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Multicenter, Randomized, Partially Blind Study to Evaluate Efficacy, Safety and Selection of the Optimal Dose for VM-1500 in Comparison to Efavirenz in Combination With Two NRTIs in Treatment-naïve, HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT02489461
- Acronym / sponsor ID
- HIV-VM1500-04
- Conditions
- HIV-1-infection
- Keywords
- HIV
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- ViriomIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2014 (actual)
- Primary completion
- 5 Apr 2016 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 3 Jul 2015 (estimated)
- 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 conducted in two stages and open-label stage of the study.
At the first stage of the study, the main purpose was to choose the optimal dose of VM-1500 (20 mg or 40 mg per day) in addition to standard-of-care basic antiretroviral therapy consisting of two NRTIs, in terms of reduction of viral load at Week 12 (<400 copies/ml) in treatment-naïve HIV-1-infected patients.
At the second stage of the study, the main purpose was to evaluate efficacy of VM- 1500 (in the optimal dose selected at the first stage of the study) in comparison to Efavirenz added to standard-of-care antiretroviral therapy of two NRTIs, in terms of reduction of viral load at Week 24 to the undetectable level (<50 copies/ml) in treatment-naïve HIV-1 infected patients.
Open-label stage of the study continued evaluation of viral load and immunological and safety parameters in HIV-1 patients receiving VM-1500 up to Week 96 and additional PK up to Week 100.
Detailed description
This project is an international, multicenter, randomized, partially blind clinical study to evaluate efficacy and safety of two different doses of VM-1500 in comparison with Efavirenz added to standard antiretroviral therapy including two NRTIs in treatment-naïve HIV-1-infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VM-1500 20 mg + ART | Experimental | Drug: VM-1500, Drug: Antiretroviral therapy (ART)VM-1500 - 20 mg (Stage I), then optimal dose (Stage II and Open-Label Stage), ART |
| VM-1500 40 mg + ART | Experimental | Drug: VM-1500, Drug: Antiretroviral therapy (ART)VM-1500 - 40 mg (Stage I), then optimal dose (Stage II and Open-Label Stage), ART |
| Efavirenz 600 mg + ART | Active comparator | Drug: Efavirenz, Drug: Antiretroviral therapy (ART)Efavirenz 600 mg (Stage I and Stage II), ART |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed Patient Information and Informed Consent Form.
- Males and females, age ≥ 18 years.
- HIV-1 infection, confirmed serologically in IFA or immunoblot analysis (or documented HIV-1 infection).
- Clinically stable HIV infection (clinical stages 1 or 2 according to the WHO classification).
- Indications (in the Investigator's opinion) for ART, according to the WHO Summary Guideline for use of antiretroviral drugs in HIV prevention and treatment (2013).
Key exclusion criteria (7 listed)
- Primary HIV-1 resistance to ART. Viral resistance mutations are defined as any basic mutations of resistance to NNRTIs, according to the updated list of VIH-1 resistance mutations (International AIDS society, 2013), associated with drug resistance in any genotype.
- History of antiretroviral therapy (ART), including for the prevention of vertical transmission of HIV.
- Acute hepatitis or hepatic cirrhosis of any etiology; anti-HCV antibodies or HBsAg at screening.
- Signs of acute infection or positive test result for syphilis, hepatitis A, Toxoplasma gondii, cytomegalovirus, gonorrhea, Chlamydia trachomatis during 30 days before screening.
- Opportunistic infections of the Category C (Centers of Disease Control (CDC), 2008), excluding Kaposi's sarcoma not requiring systemic therapy.
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 |
|---|---|---|
| VM-1500Also: Elsulfavirine, Elpida®VM-1500 up to 96 weeks | Drug | VM-1500 20 mg + ART, VM-1500 40 mg + ART |
| EfavirenzAlso: Stocrin®Efavirenz up to 48 weeks | Drug | Efavirenz 600 mg + ART |
| Antiretroviral therapy (ART)Also: standard antiretroviral therapy of two NNRTIsAntiretroviral therapy up to 96 weeks | Drug | Efavirenz 600 mg + ART, VM-1500 20 mg + ART, VM-1500 40 mg + ART |
Primary outcome
Reduction of HIV-1 RNA level in blood plasma <400 copies/ml
Time frame: 12 weeks
Comparison of the percentage of patients with reduced viral load to < 400 copies/ml at Week 12 in VM-1500 20 mg, VM-1500 40 mg and Efavirenz treatment groups
5 secondary outcomes
Reduction of HIV-1 RNA level in blood plasma <50 copies/ml
Time frame: 24 weeks
Reduction of HIV-1 RNA level in blood plasma <50 copies/ml
Time frame: 48 weeks
Change in the absolute CD4+ lymphocytes count
Time frame: 48 weeks
Change in the absolute CD8+ lymphocytes count
Time frame: 48 weeks
The percent of patients with study therapy-resistant HIV-1 development
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- 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.
Irina Y Tyrnova study chair
Viriom,LLC
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VM-1500, Efavirenz and Antiretroviral therapy (ART) in people with HIV-1-infection, run by Viriom at 13 sites in Russia.
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 7 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 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Russia. 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 combined 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.
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?
Reduction of HIV-1 RNA level in blood plasma <400 copies/ml (time frame: 12 weeks). 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 25 Sep 2018.