HIV InfectionsCOVERNCT00705419
Registry to Assess Long-term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999)
An observational study of HIV Infections, run by Merck Sharp & Dohme LLC.
Trial summary
Nonrandomized, prospective, observational, multi-site registry to assess long-term safety, clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects will be followed for up to 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Vicriviroc maleate and Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Sep 2010
- Phase
- Observational
- 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
Study population: The registry will enroll subjects who received vicriviroc or control in a Phase 2 or 3 clinical trial (with the exception of P03802 and ACTG A5211 [and its rollover P04100]), and are no longer receiving study medication.
Who may be able to join
- Subjects must have participated in a Phase 2 or 3 study involving vicriviroc, and must have received, but are no longer receiving study medication.
Who cannot join
- Unwillingness to participate in the registry or give informed consent.
About this study
Official title: COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry
Nonrandomized, prospective, observational, multi-site registry to assess long-term safety, clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects will be followed for up to 5 years.
Read the detailed description
A non-probability sampling method will be used. Subjects will be requested to enroll in the registry after having completed or discontinued participation in a Phase 2 or 3 study involving vicriviroc.
- Conditions
- HIV Infections
- Being tested
- Vicriviroc maleate, Placebo, Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg
- 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
Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol.
Vicriviroc maleateDrug
Also called SCH 417690
Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.
PlaceboDrug
Follow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol.
Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mgDrug
Also called Truvada
Follow-up for subjects who previously received active control consisting of emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg combination tablet administered once daily according to the parent protocol.
| Study group | Role | What they receive |
|---|---|---|
| Previous vicriviroc 30 mg QD | Subjects who previously received vicriviroc 30 mg daily in a Phase 2 or 3 clinical trial. Receives: Drug: Vicriviroc maleate | |
| Previous vicriviroc 20 mg QD | Subjects who previously received vicriviroc 20 mg daily in a Phase 2 or 3 clinical trial. Receives: Drug: Vicriviroc maleate | |
| Control Group | Subjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc. Receives: Drug: Placebo; Drug: Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death.
Measured: Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis.
Secondary outcomes (1)
Incidence of change in plasma viral tropism, time to change in plasma viral tropism, and change in HIV RNA and CD4+ counts, if available.
Measured: Every 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startJul 2007
- Primary completionSep 2010
- Study completionSep 2010
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 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
- NCT00705419
- Sponsor's protocol ID
- P04999
- Acronym
- COVER
- Status last verified
- Feb 2015
- First submitted
- 23 Jun 2008
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry
- ClinicalTrials.gov ID
- NCT00705419
- Acronym / sponsor ID
- COVER / P04999
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Jun 2008 (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.
Nonrandomized, prospective, observational, multi-site registry to assess long-term safety, clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects will be followed for up to 5 years.
Detailed description
A non-probability sampling method will be used. Subjects will be requested to enroll in the registry after having completed or discontinued participation in a Phase 2 or 3 study involving vicriviroc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Previous vicriviroc 30 mg QD | – | Drug: Vicriviroc maleateSubjects who previously received vicriviroc 30 mg daily in a Phase 2 or 3 clinical trial. |
| Previous vicriviroc 20 mg QD | – | Drug: Vicriviroc maleateSubjects who previously received vicriviroc 20 mg daily in a Phase 2 or 3 clinical trial. |
| Control Group | – | Drug: Placebo, Drug: Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mgSubjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry will enroll subjects who received vicriviroc or control in a Phase 2 or 3 clinical trial (with the exception of P03802 and ACTG A5211 [and its rollover P04100]), and are no longer receiving study medication.
Key inclusion criteria (1 listed)
- Subjects must have participated in a Phase 2 or 3 study involving vicriviroc, and must have received, but are no longer receiving study medication.
Key exclusion criteria (1 listed)
- Unwillingness to participate in the registry or give informed consent.
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 417690Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol. | Drug | Previous vicriviroc 30 mg QD |
| Vicriviroc maleateAlso: SCH 417690Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol. | Drug | Previous vicriviroc 20 mg QD |
| PlaceboFollow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol. | Drug | Control Group |
| Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mgAlso: TruvadaFollow-up for subjects who previously received active control consisting of emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg combination tablet administered once daily according to the parent protocol. | Drug | Control Group |
Primary outcome
Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death.
Time frame: Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis.
1 secondary outcome
Incidence of change in plasma viral tropism, time to change in plasma viral tropism, and change in HIV RNA and CD4+ counts, if available.
Time frame: Every 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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?
An observational study of 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 1 inclusion and 1 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 5 Feb 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death. (time frame: Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis.). It is what the study was designed to measure, not a finding.
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 5 Feb 2015.