HIVPhase 4NCT01275625

Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia

A Phase 4 study testing HIV therapy in people with HIV, run by ViiV Healthcare at 8 sites in Russia.

Completed

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

Trial summary

One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the efficacy and safety of this combination in a Russian population of patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV
What is being tested?: HIV therapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 8 sitesRussia
Study dates: Jun 2011to Jul 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Over 18 years of age.
R5 HIV infection on screening tropism test.
Viral load >1,000 copies/mL.
Never previously treated with anti-HIV medicines.

Who cannot join

Previously treated with anti-HIV medicines.
Hepatitis B co-infection.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Russia8 sites

Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
Krasnoyarsk, 660049
Federal scientific and methodological center on AIDS prophylaxis and control
Moscow, 105275
Moscow regional center on AIDS and infectious diseases prophylaxis and control
Moscow, 129110
Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
Nizhny Novgorod, 603005
Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control
Saint Petersburg, 190103
Federal State Institution Republican clinical infectious hospital of Roszdrav
Saint Petersburg, 196645
Smolensk Center on AIDS and infectious diseases prophylaxis and control
Smolensk, 214006
Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
Volgograd, 400040

Other trials in Russia

About this study

Official title: A Multicenter, Open Label Study Of Maraviroc, Zidovudine And Lamivudine Twice Daily For The Treatment Of Antiretroviral Naïve HIV-Infected Patients With R5 HIV-1 In Russia

Conditions: HIV
Being tested: HIV therapy
Keywords: maraviroc, naive, hiv, zidovudine, lamivudine, combivir, Clade A
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

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

HIV therapyDrug
Also called Selzentry, Celsentri
Combivir one tablet BD with maraviroc 300mg BD for 48 weeks

Study groups in NCT01275625
Study group	Role	What they receive
Treatment	Experimental	Single arm study of combivir and maraviroc for 48 weeks Receives: Drug: HIV therapy

What is being measured

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

Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.
Participants' responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
Measured: 48 weeks

Secondary outcomes (10)

Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
Measured: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
Participants' responder status at Week 48 was assessed according to MDF algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
Measured: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
Virologic Response: Rate of Virologic Failure at Week 48.
Virologic failure defined as: failure to achieve a reduction from baseline in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ. Participants with Time to loss of virologic response (defined by level of <50 copies/mL) failure were classified as rebounders or non-responders.
Measured: 48 weeks
Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count
Measured: Week 48
Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count
Measured: Week 48
Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.
Measured: Week 48
Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count.
Measured: Week 48
Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.
Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.
Measured: Week 48
Number of Participants With Genotypic Resistance.
The viral genotypes were captured at Baseline and at treatment failure or Early termination and any resistance-associated mutations summarized descriptively at Week 48 for the Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs)drug classes.
Measured: Screening to Week 48 or Time of treatment Failure
Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.
Change in tropism were summarized at the time of treatment failure or Early Termination (note: this was performed for participants with viral load > 400 copies/mL only).
Measured: Screening to Week 48 or Time of treatment Failure

Timeline

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

Jun 2011Jul 2013

First posted12 Jan 2011 (estimated)
Study startJun 2011
Primary completionOct 2012
Study completionJul 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01275625
Sponsor's protocol ID: A4001101
Status last verified: Jan 2014
First submitted: 11 Jan 2011
Last updated: 3 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lewis ME, Jubb B, Simpson P, Lopatukhin A, Kireev D, Bobkova M, Craig C, van der Ryst E, Westby M, Butler SL. Highly prevalent Russian HIV-1 V3-loop sequence variants are susceptible to maraviroc. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211025156. doi: 10.1177/20402066211025156.
PubMed 34160290

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open Label Study Of Maraviroc, Zidovudine And Lamivudine Twice Daily For The Treatment Of Antiretroviral Naïve HIV-Infected Patients With R5 HIV-1 In Russia
ClinicalTrials.gov ID: NCT01275625
Acronym / sponsor ID: A4001101
Conditions: HIV
Keywords: maraviroc, naive, hiv, zidovudine, lamivudine, combivir, Clade A
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Jun 2011
Primary completion: Oct 2012 (actual)
Study completion: Jul 2013 (actual)
First posted: 12 Jan 2011 (estimated)
Results: Posted 3 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment	Experimental	Drug: HIV therapySingle arm study of combivir and maraviroc for 48 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Over 18 years of age.
R5 HIV infection on screening tropism test.
Viral load >1,000 copies/mL.
Never previously treated with anti-HIV medicines.

Key exclusion criteria (2 listed)

Previously treated with anti-HIV medicines.
Hepatitis B co-infection.

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
HIV therapyAlso: Selzentry, CelsentriCombivir one tablet BD with maraviroc 300mg BD for 48 weeks	Drug	Treatment

Primary outcome

Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.
Time frame: 48 weeks
Participants' responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm. This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.

10 secondary outcomes

Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
Virologic Response: Rate of Virologic Failure at Week 48.
Time frame: 48 weeks
Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
Time frame: Week 48
Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
Time frame: Week 48
Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
Time frame: Week 48
Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
Time frame: Week 48
Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.
Time frame: Week 48
Number of Participants With Genotypic Resistance.
Time frame: Screening to Week 48 or Time of treatment Failure
Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.
Time frame: Screening to Week 48 or Time of treatment Failure

Results and safety

Results posted to the registry on 3 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Maraviroc+Combivir	77	64

Primary outcome: Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.

Time frame: 48 weeks. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Maraviroc+Combivir n = 77
Value	77.92 (68.01 to 87.84)

Population analysed: Full Analysis Set (FAS) Population included those participants who had taken at least 1 dose of the study drug.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to follow-up period (28 days after the last dose of study). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Maraviroc+Combivir	2 of 77 (2.6%)	51 of 77 (66.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34160290Lewis ME, Jubb B, Simpson P, Lopatukhin A, Kireev D, Bobkova M, Craig C, van der Ryst E, Westby M, Butler SL. Highly prevalent Russian HIV-1 V3-loop sequence variants are susceptible to maraviroc. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211025156. doi: 10.1177/20402066211025156.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing HIV therapy in people with HIV, run by ViiV Healthcare at 8 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 4 inclusion and 2 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 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks. (time frame: 48 weeks). 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 NCT01275625, 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 3 Mar 2014.