Acquired Immunodeficiency SyndromePhase 3NCT00478231

Multicenter, Safety Study Of Maraviroc

A Phase 3 study testing Maraviroc in people with Acquired Immunodeficiency Syndrome and HIV Infection, run by ViiV Healthcare at 16 sites in Brazil.

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

To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acquired Immunodeficiency Syndrome, HIV Infection
What is being tested?: Maraviroc
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 209 participants
Where: 16 sitesBrazil
Study dates: Jul 2007to Sep 2010
Phase: Phase 3
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

Subjects with limited or no approved treatment options available to them due to resistance or intolerance;
Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA ≥ 1000 copies/ml, at screening.
Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay.

Who cannot join

Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trials or having previously discontinued Maraviroc in trials
Potentially life threatening (Grade 4) laboratory abnormality or medical condition (according to the Division of AIDS table for grading severity of adult adverse experiences) still under investigation unless a diagnosis has been established and felt not to affect risk/benefit assessment or eventual interpretation of safety results, based on discussion between the investigator and Pfizer.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

Brazil16 sites

Pfizer Investigational Site
Belo Horizonte, Minas Gerais, 30130-100
Pfizer Investigational Site
Brasília, Federal District, 70351-580
Pfizer Investigational Site
Campinas, São Paulo, 13059-900
Pfizer Investigational Site
Campinas, São Paulo, 13083-887
Pfizer Investigational Site
Curitiba, Paraná, 80240-280
Pfizer Investigational Site
Florianópolis, Santa Catarina, 88025-301
Pfizer Investigational Site
Nova Iguaçu, Rio de Janeiro, 26030-380
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90110-270
Pfizer Investigational Site
Ribeirão Preto, São Paulo, 14048900
Pfizer Investigational Site
Salvador, Estado de Bahia, 40110-160
Pfizer Investigational Site
Santo André, São Paulo, 09060-650
Pfizer Investigational Site
São Paulo, São Paulo, 01246-900
Pfizer Investigational Site
São Paulo, São Paulo, 01307-001
Pfizer Investigational Site
São Paulo, São Paulo, 04040-002
Pfizer Investigational Site
São Paulo, São Paulo, 04121-000
Pfizer Investigational Site
São Paulo, São Paulo, 04231-030

Other trials in Brazil

About this study

Official title: A Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc

To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.

Conditions: Acquired Immunodeficiency Syndrome, HIV Infection
Being tested: Maraviroc
Keywords: Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc, Treatment Experienced
Medical subject headings: Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

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

MaravirocDrug
Maraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the presence of maraviroc.

Study groups in NCT00478231
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Maraviroc

What is being measured

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

Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death.
Measured: Baseline to 30 days post-week 96 or early termination (ET)
Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities
Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death.
Measured: Baseline to 30 days post-week 96 or ET
Number of Participants With Treatment Emergent Malignancies
Measured: Baseline to 30 days post-week 96 or ET
Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections
Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System.
Measured: Baseline to 30 days post-week 96 or ET
Number of Participants With Laboratory Test Abnormalities
Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality.
Measured: Baseline to 30 days post-week 96 or ET

Secondary outcomes (8)

Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)
Measured: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT)
Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA
Measured: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification
Below limit of quantification was defined as less than 400 copies/milliliter (mL)
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Measured: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status
Virus tropism was done by the Monogram Biosciences Trofile assay.
Measured: Time of virologic failure (VF) and Week 96 or EOT

Timeline

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

Jul 2007Sep 2010

First posted24 May 2007 (estimated)
Study startJul 2007
Primary completionAug 2010
Study completionSep 2010

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 Acquired Immunodeficiency SyndromeStudies 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 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 209 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00478231
Sponsor's protocol ID: A4001063
Status last verified: Sep 2011
First submitted: 22 May 2007
Last updated: 9 Sep 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Furtado J, Madruga JV, Bicudo EL, da Eira M, Lopes MI, Netto EM, Santini-Oliveira M, Leite OH, Machado AA, Tupinambas U, de Andrade Neto JL, Lima MP, Pedro Rde J, Miranda AF, Lewi DS, Santos BR, Portsmouth S, Wajsbrot DB, Cassoli LM. Safety and immunovirologic outcomes with maraviroc combination regimens in patients with a history of past treatment failures and virologic resistance in Brazil: an open-label, multicenter phase 3b study. AIDS Res Hum Retroviruses. 2013 Sep;29(9):1203-10. doi: 10.1089/AID.2012.0330. Epub 2013 Jun 25.
PubMed 23731330

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 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc
ClinicalTrials.gov ID: NCT00478231
Acronym / sponsor ID: A4001063
Conditions: Acquired Immunodeficiency Syndrome, HIV Infection
Keywords: Multicenter, Open Label, Non-Comparative Safety Study Of Maraviroc, Treatment Experienced
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 209 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Jul 2007
Primary completion: Aug 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 24 May 2007 (estimated)
Results: Posted 8 Aug 2011

Clinical summary

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

To collect safety and tolerability data in a more diverse patient population of patients with HIV/Aids, who have limited therapeutic options.

Study design

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

Arm	Type	Receives
1	Experimental	Drug: Maraviroc

Who may qualify

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

Key inclusion criteria (3 listed)

Subjects with limited or no approved treatment options available to them due to resistance or intolerance;
Subjects must be failing to achieve adequate virologic suppression on their current regimen and have HIV-1 RNA ≥ 1000 copies/ml, at screening.
Have only R5 HIV-1 at Screening as verified by the Monogram Biosciences Trofile assay.

Key exclusion criteria (2 listed)

Failed prior treatment with any CCR5 antagonist, in any ongoing CCR5 trials or having previously discontinued Maraviroc in trials
Potentially life threatening (Grade 4) laboratory abnormality or medical condition (according to the Division of AIDS table for grading severity of adult adverse experiences) still under investigation unless a diagnosis has been established and felt not to affect risk/benefit assessment or eventual interpretation of safety results, based on discussion between the investigator and Pfizer.

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
MaravirocMaraviroc should be dosed BID with total dose adjusted according to the other drugs the patient is taking. Maraviroc may be taken with or without food. The subject should only take missed doses if it is not within 6 hours prior to the planned next dose. No dose adjustment of OBT is required due to the presence of maraviroc.	Drug	1

Primary outcome

Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline to 30 days post-week 96 or early termination (ET)
AEs: any untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was congenital anomaly. Grade 3: Events that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4: Events which were unacceptable and intolerable or which were irreversible or caused participant to be in imminent danger of death.
Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities
Time frame: Baseline to 30 days post-week 96 or ET
Grade 3 or severe events included those that interrupted participant's usual daily activity and traditionally required systemic drug therapy or other treatment. Grade 4 or very severe events included those that were unacceptable and intolerable or which were irreversible or caused the participant to be in imminent danger of death.
Number of Participants With Treatment Emergent Malignancies
Time frame: Baseline to 30 days post-week 96 or ET
Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections
Time frame: Baseline to 30 days post-week 96 or ET
Number of participants with AIDS-related infections based on investigator classification guided by a predefined list of clinical Category C AEs per Center for Disease Control (CDC) HIV Classification System.
Number of Participants With Laboratory Test Abnormalities
Time frame: Baseline to 30 days post-week 96 or ET
Pre-defined criteria based on upper limit normal (ULN) and lower limit normal (LLN) were established for each laboratory test to define the values that would be identified as laboratory test abnormality.

8 secondary outcomes

Percentage of Participants With at Least 0.5 Log 10 Reduction in Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA)
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or end of treatment (EOT)
Percentage of Participants With at Least 1.0 Log 10 Reduction in HIV-1 RNA
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Percentage of Participants Achieving HIV-1 RNA Below Limit of Quantification
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in CD4 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Change From Baseline in CD8 Percent at Week 4, 8, 12, 24, 36, 48, 60, 72, 84 and Week 96 or EOT
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84 and Week 96 or EOT
Number of Participants With C-X-C Chemokine Receptor Type 4 {CXCR4} [X4] Tropism Status
Time frame: Time of virologic failure (VF) and Week 96 or EOT

Results and safety

Results posted to the registry on 8 Aug 2011, 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	209	125

Primary outcome: Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Baseline to 30 days post-week 96 or early termination (ET). Number. Unit: Participants

Measure	Maraviroc n = 206
Grade 3 AEs	40
Grade 4 AEs	9
SAEs	34

Population analysed: The safety analysis set composed of all participants who received at least one dose of study medication.

Primary outcome: Number of Participants With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 and Grade 4 Laboratory Abnormalities

Time frame: Baseline to 30 days post-week 96 or ET. Number. Unit: Participants

Measure	Maraviroc n = 206
Grade 3: Alanine aminotransferase (ALT)	0
Grade 3: Aspartate aminotransferase (AST)	4
Grade 3: Absolute neutrophil count (ANC)	7
Grade 3: Alkaline phosphatase	1
Grade 3: Gamma-glutamyl transpeptidase (GGT)	15
Grade 3: Hyperbilirubinemia	17
Grade 3: Hyperuricemia	3
Grade 3: Lipase (n= 101)	8

Population analysed: The safety analysis set composed of all participants who received at least one dose of study medication. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the time point for each group respectively.

Primary outcome: Number of Participants With Treatment Emergent Malignancies

Time frame: Baseline to 30 days post-week 96 or ET. Number. Unit: Participants

Measure	Maraviroc n = 206
Carcinoma in situ	1
Hodgkin's disease	1
Intestinal T-cell lymphoma	1
Neoplasm of appendix	1

Population analysed: The safety analysis set composed of all participants who received at least one dose of study medication.

Primary outcome: Number of Participants With Category C Acquired Immunodeficiency Syndrome (AIDS) Related Infections

Time frame: Baseline to 30 days post-week 96 or ET. Number. Unit: Participants

Measure	Maraviroc n = 206
Cerebral toxoplasmosis	2
Disseminated cryptococcosis	1
Oesophageal candidiasis	3
Pneumocystis jiroveci pneumonia	3
Leukoencephalopathy	1

Population analysed: The safety analysis set composed of all participants who received at least one dose of study medication.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Maraviroc	34 of 206 (16.5%)	185 of 206 (89.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23731330Furtado J, Madruga JV, Bicudo EL, da Eira M, Lopes MI, Netto EM, Santini-Oliveira M, Leite OH, Machado AA, Tupinambas U, de Andrade Neto JL, Lima MP, Pedro Rde J, Miranda AF, Lewi DS, Santos BR, Portsmouth S, Wajsbrot DB, Cassoli LM. Safety and immunovirologic outcomes with maraviroc combination regimens in patients with a history of past treatment failures and virologic resistance in Brazil: an open-label, multicenter phase 3b study. AIDS Res Hum Retroviruses. 2013 Sep;29(9):1203-10. doi: 10.1089/AID.2012.0330. Epub 2013 Jun 25.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maraviroc in people with Acquired Immunodeficiency Syndrome and HIV Infection, run by ViiV Healthcare at 16 sites in Brazil.

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 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 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Brazil. 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 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?

Yes. Results are posted in the registry (first posted 8 Aug 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?

Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline to 30 days post-week 96 or early termination (ET)). The study lists 5 primary outcomes in all. 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 NCT00478231, 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 9 Sep 2011.