HIV InfectionsPhase 3NCT00243568
Vicriviroc, a CCR5 Inhibitor, Added to an Optimized Antiretroviral Therapy for Previously Treated HIV (VICTOR-E2) (Study P04285
A Phase 3 study testing Vicriviroc in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by Merck Sharp & Dohme LLC.
Trial summary
This is an international study of vicriviroc in 500 adult HIV-infected subjects who are failing standard antiretroviral therapy (ART). HIV must be of a certain type known as R5/X4-mixed tropic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Acquired Immunodeficiency Syndrome
- What is being tested?
- Vicriviroc
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2005to not given
- Phase
- Phase 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
- Adult subjects with documented R5/X4 mixed-tropic HIV infection
- Prior therapy for greater than or equal to 3 months with greater than or equal to 3 classes of currently marketed antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening
- HIV RNA greater than or equal to 5000 copies/mL on a stable ART regimen of at least 3 months of duration
- Greater than or equal to 1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and greater than or equal to 1 primary resistance mutation to a PI
- Acceptable hematologic, renal, and hepatic laboratory parameters.
Who cannot join
- No history of recurrent seizure or CNS condition predisposing to seizure
- No active AIDS-defining opportunistic infection
- Subjects who have previously used a CCR5 inhibitor for greater than 4 weeks and/or within 30 days of the screening visit
- Use of any drugs that predispose to seizures.
About this study
Official title: Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E2)
This is an international study of vicriviroc in 500 adult HIV-infected subjects who are failing standard antiretroviral therapy (ART). HIV must be of a certain type known as R5/X4-mixed tropic. Subjects allowed into the trial will be randomly assigned to treatment with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to other antiretrovirals (selected by the investigator to be optimal for the specific subject) containing at least 3 drugs, including a protease inhibitor (PI) boosted with at least 100 mg ritonavir QD. Subjects will be continued for up to 48 weeks of dosing.
Read the detailed description
This is a randomized, placebo-controlled, multi-site, parallel-group, double-blind study of vicriviroc (SCH 417690) in 500 adult HIV-infected subjects with R5/X4 mixed viral tropism who have at least 5000 copies/mL HIV RNA despite standard antiretroviral therapy (ART) that the subject has been receiving continuously for at least 3 months. Eligible subjects will be randomized to treatment with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to an individually optimized PI-containing ART regimen containing at least 3 drugs, including a PI, boosted by at least 100 mg ritonavir QD prescribed by the investigator. The vicriviroc dose and placebo will be double-blind, and the optimized background therapy will be open-label. Treatment visits after Day 1 are scheduled for Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. A planned interim analysis will be conducted when 100 subjects have completed 12 weeks of dosing. After completion of the primary analysis (24-week virologic response of all subjects), subjects will be given the optimal dose of vicriviroc and follow-up will be continued to at least 48 weeks. Safety will be monitored by standard laboratory tests, assessment of adverse events, and emergence of complicating medical conditions. Cardiac safety will be monitored periodically by ECG, and plasma samples will be collected from all subjects through the study for population pharmacokinetic analyses.
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Being tested
- Vicriviroc
- Keywords
- HIV Infections, Acquired Immunodeficiency Syndrome, CCR5/CXCR4 mixed tropism, R5/X4 mixed tropism, CCR5 inhibitor, vicriviroc, treatment-experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VicrivirocDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study start1 Sep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243568
- Sponsor's protocol ID
- P04285
- Other IDs
- EudraCT number 2005-001058-26
- Status last verified
- Sep 2019
- First submitted
- 20 Oct 2005
- Last updated
- 12 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E2)
- ClinicalTrials.gov ID
- NCT00243568
- Acronym / sponsor ID
- P04285
- Conditions
- HIV Infections, Acquired Immunodeficiency Syndrome
- Keywords
- HIV Infections, Acquired Immunodeficiency Syndrome, CCR5/CXCR4 mixed tropism, R5/X4 mixed tropism, CCR5 inhibitor, vicriviroc, treatment-experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2005 (actual)
- First posted
- 24 Oct 2005 (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.
This is an international study of vicriviroc in 500 adult HIV-infected subjects who are failing standard antiretroviral therapy (ART). HIV must be of a certain type known as R5/X4-mixed tropic. Subjects allowed into the trial will be randomly assigned to treatment with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to other antiretrovirals (selected by the investigator to be optimal for the specific subject) containing at least 3 drugs, including a protease inhibitor (PI) boosted with at least 100 mg ritonavir QD. Subjects will be continued for up to 48 weeks of dosing.
Detailed description
This is a randomized, placebo-controlled, multi-site, parallel-group, double-blind study of vicriviroc (SCH 417690) in 500 adult HIV-infected subjects with R5/X4 mixed viral tropism who have at least 5000 copies/mL HIV RNA despite standard antiretroviral therapy (ART) that the subject has been receiving continuously for at least 3 months. Eligible subjects will be randomized to treatment with vicriviroc 10 mg QD, vicriviroc 15 mg QD, or placebo in addition to an individually optimized PI-containing ART regimen containing at least 3 drugs, including a PI, boosted by at least 100 mg ritonavir QD prescribed by the investigator. The vicriviroc dose and placebo will be double-blind, and the optimized background therapy will be open-label. Treatment visits after Day 1 are scheduled for Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. A planned interim analysis will be conducted when 100 subjects have completed 12 weeks of dosing. After completion of the primary analysis (24-week virologic response of all subjects), subjects will be given the optimal dose of vicriviroc and follow-up will be continued to at least 48 weeks. Safety will be monitored by standard laboratory tests, assessment of adverse events, and emergence of complicating medical conditions. Cardiac safety will be monitored periodically by ECG, and plasma samples will be collected from all subjects through the study for population pharmacokinetic analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects with documented R5/X4 mixed-tropic HIV infection
- Prior therapy for greater than or equal to 3 months with greater than or equal to 3 classes of currently marketed antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening
- HIV RNA greater than or equal to 5000 copies/mL on a stable ART regimen of at least 3 months of duration
- Greater than or equal to 1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and greater than or equal to 1 primary resistance mutation to a PI
- Acceptable hematologic, renal, and hepatic laboratory parameters.
Key exclusion criteria (4 listed)
- No history of recurrent seizure or CNS condition predisposing to seizure
- No active AIDS-defining opportunistic infection
- Subjects who have previously used a CCR5 inhibitor for greater than 4 weeks and/or within 30 days of the screening visit
- Use of any drugs that predispose to seizures.
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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vicriviroc in people with HIV Infections and Acquired Immunodeficiency Syndrome, 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 5 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: withdrawn, as of the sponsor's last update on 12 Sep 2019. 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 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 was withdrawn before enrolling participants, so there are no results.
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.
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 12 Sep 2019.