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Human Immunodeficiency Virus-1Phase 2NCT00827112

A Pilot Study Of A Novel Treatment Regimen, Maraviroc + Ritonavir Boosted Atazanavir, In Treatment Naive HIV-Infected Patients

A Phase 2 study testing maraviroc in people with Human Immunodeficiency Virus-1, run by ViiV Healthcare at 39 sites in 3 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Human Immunodeficiency Virus-1
What is being tested?
maraviroc
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
39 sitesin 3 countries
Study dates
Mar 2009to Jul 2011
Phase
Phase 2
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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • HIV-1 RNA viral load of ≥1,000 copies/mL measured at the Screening Visit.
  • CD4 count ≥100 cells/mm3 at Screening.
  • Have only R5 HIV-1 at Screening as verified by the Monogram Bioscience Trofile® assay with enhanced sensitivity.

Who cannot join

  • Prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
  • Any evidence of resistance to atazanavir, tenofovir, and emtricitabine.
  • X4-or dual/mixed-tropic virus by enhanced Trofile assay or repeated assay failure or not reportable results.

Trial locations and contacts

39 sites in 3 countries.

39 sites in 3 countries

United States27 sites

  • Pfizer Investigational Site

    Addison, Texas, 75001

  • Pfizer Investigational Site

    Ann Arbor, Michigan, 48109

  • Pfizer Investigational Site

    Atlanta, Georgia, 30312

  • Pfizer Investigational Site

    Chicago, Illinois, 60657

  • Pfizer Investigational Site

    Dallas, Texas, 75204

  • Pfizer Investigational Site

    Dallas, Texas, 75390

  • Pfizer Investigational Site

    Houston, Texas, 77098

  • Pfizer Investigational Site

    Huntersville, North Carolina, 28078

  • Pfizer Investigational Site

    Los Angeles, California, 90027

  • Pfizer Investigational Site

    Los Angeles, California, 90028

  • Pfizer Investigational Site

    Los Angeles, California, 90048

  • Pfizer Investigational Site

    Los Angeles, California, 90069

  • Pfizer Investigational Site

    Miami, Florida, 33133

  • Pfizer Investigational Site

    Miami, Florida, 33136

  • Pfizer Investigational Site

    Miami, Florida, 33137

  • Pfizer Investigational Site

    New York, New York, 10003

  • Pfizer Investigational Site

    Norwalk, Connecticut, 06851

  • Pfizer Investigational Site

    Omaha, Nebraska, 68106

  • Pfizer Investigational Site

    Orlando, Florida, 32803

  • Pfizer Investigational Site

    Pensacola, Florida, 32504

  • Pfizer Investigational Site

    Spokane, Washington, 99204

  • Pfizer Investigational Site

    Springfield, Massachusetts, 01107

  • Pfizer Investigational Site

    Springfield, Massachusetts, 01199

  • Pfizer Investigational Site

    St. Petersburg, Florida, 33713

  • Pfizer Investigational Site

    Tampa, Florida, 33602

  • Pfizer Investigational Site

    Tampa, Florida, 33614

  • Pfizer Investigational Site

    Washington D.C., District of Columbia, 20009

Other trials in United States

Germany6 sites

  • Pfizer Investigational Site

    Berlin, 10243

  • Pfizer Investigational Site

    Berlin, 12157

  • Pfizer Investigational Site

    Cologne, 50937

  • Pfizer Investigational Site

    Frankfurt am Main, 60590

  • Pfizer Investigational Site

    Hamburg, 20146

  • Pfizer Investigational Site

    München, 80335

Other trials in Germany

Spain6 sites

  • Pfizer Investigational Site

    Alicante, Alicante, 03010

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08036

  • Pfizer Investigational Site

    Córdoba, Cordoba, 14004

  • Pfizer Investigational Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Pfizer Investigational Site

    Madrid, Madrid, 28046

  • Pfizer Investigational Site

    Seville, Sevilla, 41013

Other trials in Spain

About this study

Official title: Pilot Study Of Novel Combination Of Maraviroc + Atazanavir/Ritonavir vs. Atazanavir/Ritonavir + Emtricitabine/Tenofovir For The Treatment Of Naïve HIV-Infected Patients With R5 HIV-1

This is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive HIV infected patients. Based on the results from this study, a confirmatory phase 3 study may be conducted.

Being tested
maraviroc
Keywords
CCR5-tropic HIV-1 virus

What participants receive

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

  • maravirocDrug

    Also called maraviroc =Celsentri, Selzentry; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia; darunavir=Prezista

    maraviroc (Selzentry, Celsentri) 150mg QD + atazanavir (Reyataz) /ritonavir (Norvir) (300/100mg) QD OR maraviroc (Selzentry, Celsentri) 150mg QD+ darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR maraviroc (Selzentry, Celsentri) 150mg QD+ lopinavir/ritonavir (Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))

  • maravirocDrug

    Also called maraviroc=Celsentri, Selzentry; emtricitabine/tenofovir=Truvada; atazanavir =Reyataz; ritonavir =Norvir; lopinavir/ritonavir=Kaletra, Aluvia

    emtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + darunavir (Prezista)/ritonavir (Norvir) (800/100 mg) QD (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by darunavir (Prezista)/ritonavir (Norvir)) OR emtricitabine/tenofovir (Truvada) 200/300 mg QD + lopinavir/ritonavir(Kaletra, Aluvia) (400/100 mg) BID (if atazanavir (Reyataz) /ritonavir (Norvir) is replaced by lopinavir/ritonavir (Kaletra, Aluvia))

Study groups in NCT00827112
Study groupRoleWhat they receive
Arm AExperimentalmaraviroc (Selzentry, Celsentri) 150 mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir (Reyataz) in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir (Prezista)/ritonavir (Norvir)((800/100 mg) QD or lopinavir/ritonavir (Kaletra, Aluvia)(400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir (Prezista)/ritonavir (Norvir) or lopinavir/ritonavir (Kaletra, Aluvia)(, then the subject must be discontinued from the study.
Receives: Drug: maraviroc
Arm BExperimentalemtricitabine/tenofovir (Truvada) 200/300mg QD + atazanavir (Reyataz) /ritonavir (Norvir) 300/100 mg QD Subjects experiencing unconjugated hyperbilirubinemia attributable to atazanavir (Reyataz) /ritonavir (Norvir) without any other etiology of hyperbilirubinemia, responding to the therapy without virologic failure, but expressing cosmetic concerns because of the jaundice or scleral icterus (associated with bilirubin elevations) and wish to discontinue atazanavir in spite of reassurances by the investigator, will be permitted on a single occasion only to switch to another protease inhibitor either darunavir/ritonavir (800/100 mg) QD or lopinavir/ritonavir (400/100mg) BID and remain in the study. If the investigator decides to switch to a protease inhibitor other than darunavir/ritonavir or lopinavir/ritonavir, then the subject must be discontinued from the study.
Receives: Drug: maraviroc

What is being measured

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

  1. Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than 50 Copies/Milliliter (mL)

    Measured: Week 48

Secondary outcomes (15)

  1. HIV-1 RNA Levels at Baseline

    Measured: Baseline

  2. Change From Baseline in HIV-1 RNA Levels of First 15 Participants at Days 4, 7, 10 and 14

    Plasma HIV-1 RNA levels were evaluated for first 15 participants enrolled at United States (U.S) sites only.

    Measured: Baseline , Days 4, 7, 10 and 14

  3. Maximum Observed Plasma Concentration (Cmax) of Maraviroc

    Measured: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)

  4. Minimum Observed Plasma Concentration (Cmin) of Maraviroc

    Measured: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)

  5. Average Observed Plasma Concentration (Cavg) of Maraviroc

    Cavg was described as area under the plasma concentration-time profile from time zero to time 24 hours (AUC24) divided by the dosing interval (AUC24/ 24).

    Measured: Day 14 (0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose)

  6. Change From Baseline in Plasma log10 Viral Load at Weeks 16, 24, 48 and 96

    Measured: Baseline, Week 16, Week 24, Week 48, Week 96

  7. Percentage of Participants With Less Than 50 Copies/mL of HIV-1 RNA

    Measured: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96

  8. Percentage of Participants With Less Than 400 Copies/mL of HIV-1 RNA

    Measured: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, Week 96

  9. Time to Loss of Virological Response (TLOVR)

    TLOVR (virological failure) was defined as the time from first dose of study treatment (Day 1) until the time of virologic failure using the time to loss of virologic response algorithm.

    Measured: Baseline through Week 96

  10. Time-Averaged Difference (TAD) in log10 Viral Load

    TAD was calculated as area under the curve of HIV divided by time period minus baseline HIV where HIV was denoted as HIV-1 RNA (log10 copies/mL).

    Measured: Week 16, Week 24, Week 48, Week 96

  11. Change From Baseline in Cluster of Differentiation 4+T Lymphocyte (CD4) Cell Counts at Weeks 16, 24, 48 and 96

    Measured: Baseline, Week 16, Week 24, Week 48, Week 96

  12. Change From Baseline in Cluster of Differentiation 8+T Lymphocyte (CD8) Cell Count at Weeks 16, 24, 48 and 96

    Measured: Baseline, Week 16, Week 24, Week 48, Week 96

  13. Number of Participants With Genotypic Resistance

    Genotypic resistance was assessed for all participants at screening and was evaluated for protease inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs) using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.

    Measured: Week 96 or Time of treatment failure

  14. Number of Participants With Phenotypic Resistance

    Phenotypic resistance was assessed for all participants at screening and was evaluated for PIs, NRTIs, and NNRTIs using Monogram GenoSeq and/or PhenoSenseGT assays. This was then repeated for all participants with HIV-1 viral load more than 500 copies/mL either at treatment failure or at early termination, up to Week 96.

    Measured: Week 96 or Time of treatment failure

  15. Number of Participants With HIV-1 RNA Tropism Status Using Trofile Assay

    Viral tropism was determined using the trofile assay with enhanced sensitivity for participants with HIV-1 RNA greater than equal to 1000 copies/mL. The enhanced trofile assay had the sensitivity to detect 100 percent of spiked samples when C-X-C chemokine receptor type 4 {CXCR4} [X4]-using HIV-1 RNA represented 0.3 percent of the total viral population.

    Measured: Baseline to Week 96 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.

  1. First posted22 Jan 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionJul 2010
  4. Study completionJul 2011

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00827112
Sponsor's protocol ID
A4001078
Status last verified
Jun 2012
First submitted
21 Jan 2009
Last updated
15 Jun 2012
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing maraviroc in people with Human Immunodeficiency Virus-1, run by ViiV Healthcare at 39 sites in 3 countries.

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 3 inclusion and 3 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 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Germany, Spain. 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?

Yes. Results are posted in the registry (first posted 24 Nov 2011). 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) Levels Less Than 50 Copies/Milliliter (mL) (time frame: 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 NCT00827112.

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 15 Jun 2012.

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