HIVPhase 2NCT00686829

Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)

A Phase 2 study testing Vicriviroc maleate in people with HIV and HIV Infections, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV, HIV Infections
What is being tested?: Vicriviroc maleate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: No sites listed yet
Study dates: 30 Jun 2005to 21 Oct 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Successful completion of ACTG Protocol A5211, or favorable response in A5211 but discontinued due to tropism shift, or screened for A5211 and met inclusion/exclusion criteria but unable to enroll due to protocol closure.
Participants must also be on a ritonavir-containing antiretroviral regimen at entry, and have acceptable hematologic and laboratory parameters.
Female participants of reproductive potential must agree to use 2 reliable methods of contraception, including a barrier method, and must have a negative urine pregnancy test prior to dosing.

Who cannot join

History of seizure or drug use that increases risk of seizure, current use of CYP3A4 inducers, prior history of malignancy, active drug or alcohol use or dependence that would interfere with study requirements
Female participants who are breast-feeding, pregnant, or plan to become pregnant
Participation in a clinical trial with another investigational drug.
Participants with serious illness requiring systemic therapy and/or hospitalization must not begin VCV (if not already on VCV) until participant completes therapy or is clinically stable on therapy for at least 14 days prior to enrollment.

About this study

Official title: Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211

The purpose of this study is to provide open-label vicriviroc (VCV) to human immunodeficiency virus (HIV) treatment-experienced participants who successfully completed 48 weeks of treatment on Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) protocol A5211 (or who responded favorably to treatment but discontinued participation due to viral tropism shifts), and participants who screened for ACTG A5211 and met all inclusion/exclusion criteria, but were unable to enroll due to protocol closure.

Conditions: HIV, HIV Infections
Being tested: Vicriviroc maleate
Keywords: Treatment Experienced
Medical subject headings: HIV Infections

What participants receive

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

Vicriviroc maleateDrug
Also called SCH 417690
VCV 30 mg tablet once daily by mouth.

Study groups in NCT00686829
Study group	Role	What they receive
VCV 30 mg	Experimental	Participants take VCV 30 mg once daily. Receives: Drug: Vicriviroc maleate

What is being measured

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

Percentage of Participants With ≥1 Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
Measured: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Percentage of Participants Discontinuing Study Therapy Due to AEs
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
Measured: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
An SAE is any adverse occurrence that results in death; is life-threatening; results in a persistent disability; requires in-patient hospitalization or prolongs hospitalization; or is a congenital anomaly/birth defect.
Measured: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
The percentage of participants with HIV RNA <50 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Measured: Every 12 months up to 60 months
Percentage of Participants With HIV RNA >50 to <400 Copies/mL
The percentage of participants with HIV RNA >50 to <400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Measured: Every 12 months up to 60 months
Percentage of Participants With HIV RNA ≥400 Copies/mL
The percentage of participants with HIV RNA ≥400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Measured: Every 12 months up to 60 months
Number of Participants With Coreceptor Tropism Shifts From Baseline
The number of participants with non reportable (NR) tropism, CCR5 (R5) tropism, or dual/mixed CCR5/CXCR4 (DM/X4) tropism at baseline, who had NR, R5, or DM/X4 tropism at the time of virologic failure (VF) is reported. The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
Measured: Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 years
Mean Change From Baseline in CD4/CD8 Cell Counts
The mean change from baseline in CD4/CD8 counts throughout P4100 until the time of VF is reported. "Month" was defined as each 28-day period on study treatment. A fluorescent-activated cell sorter (FACS) analysis was used to quantify CD4/CD8 lymphocytes. The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
Measured: Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 years
Number of Participants With Reduced Susceptibility to VCV
The total number of participants with viruses having phenotypic resistance to VCV is reported. Viruses exhibiting both maximum percent inhibition (MPI) plateau values of <85% and relative MPI (R-MPI) values of <0.9 (based on the PhenoSense HIV entry assay) were considered to have phenotypic resistance to VCV.
Measured: Up to time of VF in P4100, assessed up to approximately 5.5 years
Number of Participants With AIDS-defining Events (ADEs)
The number of participants with ADEs is reported. An ADE is an SAE that is expected in the course of disease and not considered related to study intervention. The sponsor identified events that met ADE criteria based on the 1993 Centers for Disease Control (CDC) Revised Classification System.
Measured: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
Number of Participants With New Infections
The number of participants with new infections is reported.
Measured: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)

Timeline

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

30 Jun 200521 Oct 2010

First posted30 May 2008 (estimated)
Study start30 Jun 2005
Primary completion21 Oct 2010
Study completion21 Oct 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 (3)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00686829
Sponsor's protocol ID: P04100
Other IDs: MK-7690-027
Status last verified: Dec 2020
First submitted: 27 May 2008
Last updated: 3 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Wilkin TJ, Su Z, Krambrink A, Long J, Greaves W, Gross R, Hughes MD, Flexner C, Skolnik PR, Coakley E, Godfrey C, Hirsch M, Kuritzkes DR, Gulick RM. Three-year safety and efficacy of vicriviroc, a CCR5 antagonist, in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2010 Aug;54(5):470-6. doi: 10.1097/qai.0b013e3181e2cba0.
PubMed 20672447
Yeh TM, Evans SR, Gulick RM, Clifford DB. Vicriviroc and peripheral neuropathy: results from AIDS Clinical Trials Group 5211. HIV Clin Trials. 2010 Jan-Feb;11(1):51-8. doi: 10.1310/hct1101-51.
PubMed 20400411
Tsibris AM, Paredes R, Chadburn A, Su Z, Henrich TJ, Krambrink A, Hughes MD, Aberg JA, Currier JS, Tashima K, Godfrey C, Greaves W, Flexner C, Skolnik PR, Wilkin TJ, Gulick RM, Kuritzkes DR. Lymphoma diagnosis and plasma Epstein-Barr virus load during vicriviroc therapy: results of the AIDS Clinical Trials Group A5211. Clin Infect Dis. 2009 Mar 1;48(5):642-9. doi: 10.1086/597007.
PubMed 19191652

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vicriviroc (SCH 417690) Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol A5211
ClinicalTrials.gov ID: NCT00686829
Acronym / sponsor ID: P04100
Conditions: HIV, HIV Infections
Keywords: Treatment Experienced
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 30 Jun 2005 (actual)
Primary completion: 21 Oct 2010 (actual)
Study completion: 21 Oct 2010 (actual)
First posted: 30 May 2008 (estimated)
Results: Posted 3 Dec 2020

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
VCV 30 mg	Experimental	Drug: Vicriviroc maleateParticipants take VCV 30 mg once daily.

Who may qualify

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

Key inclusion criteria (3 listed)

Successful completion of ACTG Protocol A5211, or favorable response in A5211 but discontinued due to tropism shift, or screened for A5211 and met inclusion/exclusion criteria but unable to enroll due to protocol closure.
Participants must also be on a ritonavir-containing antiretroviral regimen at entry, and have acceptable hematologic and laboratory parameters.
Female participants of reproductive potential must agree to use 2 reliable methods of contraception, including a barrier method, and must have a negative urine pregnancy test prior to dosing.

Key exclusion criteria (4 listed)

History of seizure or drug use that increases risk of seizure, current use of CYP3A4 inducers, prior history of malignancy, active drug or alcohol use or dependence that would interfere with study requirements
Female participants who are breast-feeding, pregnant, or plan to become pregnant
Participation in a clinical trial with another investigational drug.
Participants with serious illness requiring systemic therapy and/or hospitalization must not begin VCV (if not already on VCV) until participant completes therapy or is clinically stable on therapy for at least 14 days prior to 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
Vicriviroc maleateAlso: SCH 417690VCV 30 mg tablet once daily by mouth.	Drug	VCV 30 mg

Primary outcome

Percentage of Participants With ≥1 Adverse Events (AEs)
Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
Percentage of Participants Discontinuing Study Therapy Due to AEs
Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, biologic (at any dose), or medical device, which does not necessarily have a causal relationship with the treatment.
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
An SAE is any adverse occurrence that results in death; is life-threatening; results in a persistent disability; requires in-patient hospitalization or prolongs hospitalization; or is a congenital anomaly/birth defect.
Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL
Time frame: Every 12 months up to 60 months
The percentage of participants with HIV RNA <50 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Percentage of Participants With HIV RNA >50 to <400 Copies/mL
Time frame: Every 12 months up to 60 months
The percentage of participants with HIV RNA >50 to <400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Percentage of Participants With HIV RNA ≥400 Copies/mL
Time frame: Every 12 months up to 60 months
The percentage of participants with HIV RNA ≥400 copies/mL at each time point is reported. For this measure, "month" was defined as each 28-day period on study treatment. The Roche Amplicor® HIV-1 monitor test was used to quantify HIV RNA.
Number of Participants With Coreceptor Tropism Shifts From Baseline
Time frame: Baseline (Week 48 of ACTG study A5211) and time of VF in P4100, assessed up to approximately 5.5 years
The number of participants with non reportable (NR) tropism, CCR5 (R5) tropism, or dual/mixed CCR5/CXCR4 (DM/X4) tropism at baseline, who had NR, R5, or DM/X4 tropism at the time of virologic failure (VF) is reported. The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
Mean Change From Baseline in CD4/CD8 Cell Counts
Time frame: Baseline (Week 48 of ACTG study A5211) and up to time of VF in P4100, assessed up to approximately 5.5 years
The mean change from baseline in CD4/CD8 counts throughout P4100 until the time of VF is reported. "Month" was defined as each 28-day period on study treatment. A fluorescent-activated cell sorter (FACS) analysis was used to quantify CD4/CD8 lymphocytes. The definition of VF is an increase in HIV RNA level >0.5 log10 copies/mL compared to the baseline HIV RNA level.
Number of Participants With Reduced Susceptibility to VCV
Time frame: Up to time of VF in P4100, assessed up to approximately 5.5 years
The total number of participants with viruses having phenotypic resistance to VCV is reported. Viruses exhibiting both maximum percent inhibition (MPI) plateau values of <85% and relative MPI (R-MPI) values of <0.9 (based on the PhenoSense HIV entry assay) were considered to have phenotypic resistance to VCV.
Number of Participants With AIDS-defining Events (ADEs)
Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
The number of participants with ADEs is reported. An ADE is an SAE that is expected in the course of disease and not considered related to study intervention. The sponsor identified events that met ADE criteria based on the 1993 Centers for Disease Control (CDC) Revised Classification System.
Number of Participants With New Infections
Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)
The number of participants with new infections is reported.

Results and safety

Results posted to the registry on 3 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VCV 30 mg	79	0

Primary outcome: Percentage of Participants With ≥1 Adverse Events (AEs)

Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years). Number. Unit: Percentage of Participants

Measure	VCV 30 mg n = 79
Value	91

Population analysed: All treated participants are included.

Primary outcome: Percentage of Participants Discontinuing Study Therapy Due to AEs

Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years). Number. Unit: Percentage of Participants

Measure	VCV 30 mg n = 79
Value	6

Population analysed: All treated participants are included.

Primary outcome: Percentage of Participants With ≥1 Serious Adverse Events (SAEs)

Time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years). Number. Unit: Percentage of Participants

Measure	VCV 30 mg n = 79
Value	48

Population analysed: All treated participants are included.

Primary outcome: Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL

Time frame: Every 12 months up to 60 months. Number. Unit: Percentage of Participants

Measure	VCV 30 mg n = 79
Month 12	52
Month 24	64
Month 36	80
Month 48	89
Month 60	80

Population analysed: All treated participants with HIV RNA data available are included.

Adverse events

Time frame: Up to approximately 5.5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VCV 30 mg	38 of 79 (48.1%)	70 of 79 (88.6%)	3 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20672447Wilkin TJ, Su Z, Krambrink A, Long J, Greaves W, Gross R, Hughes MD, Flexner C, Skolnik PR, Coakley E, Godfrey C, Hirsch M, Kuritzkes DR, Gulick RM. Three-year safety and efficacy of vicriviroc, a CCR5 antagonist, in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2010 Aug;54(5):470-6. doi: 10.1097/qai.0b013e3181e2cba0.
Results publication: PubMed 20400411Yeh TM, Evans SR, Gulick RM, Clifford DB. Vicriviroc and peripheral neuropathy: results from AIDS Clinical Trials Group 5211. HIV Clin Trials. 2010 Jan-Feb;11(1):51-8. doi: 10.1310/hct1101-51.
Results publication: PubMed 19191652Tsibris AM, Paredes R, Chadburn A, Su Z, Henrich TJ, Krambrink A, Hughes MD, Aberg JA, Currier JS, Tashima K, Godfrey C, Greaves W, Flexner C, Skolnik PR, Wilkin TJ, Gulick RM, Kuritzkes DR. Lymphoma diagnosis and plasma Epstein-Barr virus load during vicriviroc therapy: results of the AIDS Clinical Trials Group A5211. Clin Infect Dis. 2009 Mar 1;48(5):642-9. doi: 10.1086/597007.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vicriviroc maleate in people with HIV and HIV Infections, run by Merck Sharp & Dohme LLC.

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 4 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 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

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 3 Dec 2020). 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 ≥1 Adverse Events (AEs) (time frame: Up to discontinuation of commercial VCV availability (up to approximately 5.5 years)). The study lists 11 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 NCT00686829, which also lists 3 linked publications.

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 Dec 2020.