HIV InfectionsPhase 2NCT00082498
Safety and Effectiveness of the Oral HIV Entry Inhibitor Vicriviroc in HIV Infected Patients
A Phase 2 study testing SCH-D (vicriviroc) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 30 sites in United States.
Trial summary
New treatment options are critical for treatment-experienced HIV infected patients with drug resistance. HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV drugs. 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?
- SCH-D (vicriviroc)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 30 sitesUnited States
- Study dates
- May 2004to Jan 2011
- Phase
- Phase 2
- 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
- HIV infected
- Experiencing virologic failure on current ART regimen
- Current ART regimen contains ritonavir (100 to 800 mg/day) and has been stable for at least 8 weeks prior to study entry. If amprenavir or fosamprenavir is part of the regimen, 200 to 800 mg/day ritonavir must be used for at least 2 weeks prior to study entry.
- Experienced virologic failure on at least one ART regimen containing 3 or more drugs prior to current failing regimen
- CD4 count of 50 cells/mm3 or more within 6 weeks prior to study entry
- HIV viral load of 5,000 copies/ml or more within 6 weeks prior to study entry
Show all 12Show fewer
- HIV strain of R5-only phenotype within 6 weeks prior to study entry
- Willing to use acceptable forms of contraception
- Able and willing to adhere to study dose and visit schedules
- HIV viral load not suppressed by at least 1log10 below baseline viral load by Week 16 or after
- QTc interval on EKG less than 500 msec, and less than 60 msec increase from baseline within 14 days of Step 2 entry
- Use of vicriviroc in Step 1 or 2 of this study or the Schering rollover study. Participants who are currently not taking vicriviroc are eligible.
Who cannot join
- Hepatitis C antibody and RNA positive
- Hepatitis B surface antigen positive
- Efavirenz or nevirapine use within 8 weeks of study entry
- Vaccination within 2 weeks prior to study screening
- Investigational agents within 30 days prior to study entry
- Systemic cancer chemotherapy or other systemic cytotoxic agents within 30 days prior to study entry
Show all 20Show fewer
- Immunosuppressants within 30 days prior to study entry. Systemic corticosteroids at replacement doses (10 mg/day prednisone or less) are not excluded.
- Immunomodulators within 30 days prior to study entry
- Considered at risk for seizure: history of seizure, recent history of head trauma with loss of consciousness, central nervous system (CNS) tumors, or other CNS problems that, in the opinion of the investigator, pose increased risk for seizure
- Medications to prevent seizures or with the potential to cause seizures within 30 days prior to study entry
- Allergy to SCH 417690 or its components
- Alcohol or drug abuse that, in the opinion of the investigator, would interfere with the study
- Serious illness requiring systemic treatment or hospitalization. A patient who is clinically stable on therapy is not excluded.
- Any clinically significant disease or condition that, in the opinion of the investigator, may interfere with the study
- Require certain medications
- Pregnancy or breastfeeding
- Have X4 or X4/R5 tropic virus, as determined by the HIV-1 coreceptor tropism assay
- Intend to use efavirenz or nevirapine in background ART regimen
- Allergy to vicriviroc or its formulations
- Pregnancy
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
The Ponce de Leon Center CRS
Atlanta, Georgia, 30308-2012
University of Colorado Hospital CRS
Aurora, Colorado, 80045
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, 02114
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
Boston, Massachusetts, 02115
Bmc Actg Crs
Boston, Massachusetts, 02118
Chapel Hill CRS
Chapel Hill, North Carolina, 27514
Rush University CRS
Chicago, Illinois, 60612
Case CRS
Cleveland, Ohio, 44106
MetroHealth CRS
Cleveland, Ohio, 44109
Ohio State University CRS
Columbus, Ohio, 43210
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, 77555-0435
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
UCLA CARE Center CRS
Los Angeles, California, 90035
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, 37204
Beth Israel Med. Ctr., ACTU
New York, New York, 10003
Weill Cornell Chelsea CRS
New York, New York, 10011
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Weill Cornell Uptown CRS
New York, New York, 10065
Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, 94304-5350
Penn Therapeutics, CRS
Philadelphia, Pennsylvania, 19104
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213-2582
The Miriam Hospital Clinical Research Site (TMH CRS) CRS
Providence, Rhode Island, 02906
Trillium Health ACTG CRS
Rochester, New York, 14607
Univ. of Rochester ACTG CRS
Rochester, New York, 14642
UCSD Antiviral Research Center CRS
San Diego, California, 92103
Ucsf Hiv/Aids Crs
San Francisco, California, 94110
Santa Clara Valley Med. Ctr.
San Jose, California, 95128
University of Washington AIDS CRS
Seattle, Washington, 98104
Washington University Therapeutics (WT) CRS
St Louis, Missouri, 63110
Georgetown University CRS (GU CRS)
Washington D.C., District of Columbia, 20007
About this study
Official title: Phase II, Randomized, Double-Blind Study of the Safety and Efficacy of Vicriviroc (An Orally Administered HIV-1 Entry Inhibitor) in HIV-Infected, Treatment-Experienced Subjects
New treatment options are critical for treatment-experienced HIV infected patients with drug resistance. HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV drugs. This study will test the safety and effectiveness of three different doses of vicriviroc (formerly known as Schering D, SCH-D, or SCH 417690) in HIV infected patients.
Read the detailed description
Vicriviroc is an oral HIV-1 entry inhibitor that targets the CCR5 receptor of T cells. Vicriviroc has been shown safe, well-tolerated, and active in Phase I clinical trials in treatment-naive HIV infected patients. The goal of this study is to evaluate the antiretroviral activity of three dose levels of vicriviroc in HIV infected, treatment-experienced patients who are failing their current ritonavir-containing antiretroviral therapy (ART).
The study will last at least 48 weeks, but no more than 5 years. There are 3 steps in this study. Patients will be randomly assigned to one of 4 groups. Group 1 will receive placebo; Group 2 will receive 5 mg vicriviroc daily; Group 3 will receive 10 mg vicriviroc daily; and Group 4 will receive 15 mg vicriviroc daily. If at or after Week 16 a participant's viral load has not met certain criteria, a dose increase of vicriviroc may occur and the participant will enter Step 2. As of 10/12/05, patients in Group 2 and any patients who entered Step 2 following virologic failure in Step 1 will be unblinded and offered either 15 mg vicriviroc daily through this study or the option of seeking alternative treatment. All patients will continue their current ART (not provided by the study). After two weeks, patients will receive ART optimized by the results of genotypic/phenotypic testing performed at study screening. All participants who have received or are receiving vicriviroc will enter Step 3 and be followed for an additional 4 years. Participants who complete the study may be eligible to receive vicriviroc through a rollover study sponsored by Schering-Plough, the drug's manufacturer.
Physical exams and blood collection will occur at study entry, Day 4, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Additionally, blood will be drawn twice, at least 2 hours apart, at both Weeks 2 and 8 for vicriviroc pharmacokinetic analysis. Patients will undergo an electrocardiogram (EKG) at Weeks 2, 8, 24, and 48. Patients will be assessed for peripheral neuropathy at study entry and Weeks 24 and 48, and will be asked to complete an adherence questionnaire at entry and Weeks 2, 8, 16, 24, 32, 40, and 48. For Step 3 participants undergoing follow-up, physical exams and blood work will occur every 6 months for 4 years.
Five participants currently enrolled at four sites that are no longer receiving funding and who will not be transferred or redirected to a site within their proximity will be subject to the following changes. There will no longer be follow-up visits per the schedule of events described in the protocol. Instead, participants will have their follow-up limited to self-report through telephone interviews to ascertain vital status, occurrence of malignancies (if any), and collection of information such as HIV-1 RNA and CD4 cell count. For these participants only, the HIV-1 RNA and CD4 cell count will be done as part of the participant's clinical care and will not be paid for by the study. The follow-up telephone interviews will be conducted at six-month intervals using the script provided by the study team.
- Conditions
- HIV Infections
- Being tested
- SCH-D (vicriviroc), Placebo
- Keywords
- SCH-D, Schering D, Treatment Experienced, Entry Inhibitors, Fusion Inhibitors, Vicriviroc
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH-D (vicriviroc)Drug
Group 2 will receive 5 mg vicriviroc daily; Group 3 will receive 10 mg vicriviroc daily; and Group 4 will receive 15 mg vicriviroc daily. If at or after Week 16 a participant's viral load has not met certain criteria, a dose increase of vicriviroc may occur and the participant will enter Step 2. As of 10/12/05, patients in Group 2 and any patients who entered Step 2 following virologic failure in Step 1 will be unblinded and offered either 15 mg vicriviroc daily through this study or the option of seeking alternative treatment.
PlaceboDrug
Patients in Group 1 will receive placebo.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Group 1 will receive placebo Receives: Drug: Placebo |
| 2 | Experimental | Group 2 will receive 5 mg vicriviroc daily Receives: Drug: SCH-D (vicriviroc) |
| 3 | Experimental | Group 3 will receive 10 mg vicriviroc daily Receives: Drug: SCH-D (vicriviroc) |
| 4 | Experimental | Group 4 will receive 15 mg vicriviroc daily Receives: Drug: SCH-D (vicriviroc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HIV-1 viral load
Measured: From baseline to Day 14
Secondary outcomes (6)
Safety and tolerability
Measured: Throughout the study
Virologic and immunologic outcomes
Measured: Throughout the study
Clinical outcomes
Measured: Throughout the study
Pharmacokinetic outcomes
Measured: At Weeks 2 and 8
Viral coreceptor phenotype
Measured: At study entry, Day 4, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Adherence measures
Measured: At study entry and Weeks 2, 8, 16, 24, 32, 40, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2004 (estimated)
- Study startMay 2004
- Primary completionDec 2005
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Responsible party
- Sponsor
- Investigators
- Roy M. Gulick, MD, MPH, Study chair, Cornell HIV Clinical Trials UnitCharles Flexner, MD, Study chair, Johns Hopkins University HospitalDaniel Kuritzkes, MD, Study chair, Harvard Medical School, Partners AIDS Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082498
- Sponsor's protocol ID
- A5211
- Other IDs
- 10097, ACTG A5211, 5K24AI051966-03
- Status last verified
- Oct 2021
- First submitted
- 11 May 2004
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Marks K, Gulick RM. New antiretroviral agents for the treatment of HIV infection. Curr HIV/AIDS Rep. 2004 Jun;1(2):82-8. doi: 10.1007/s11904-004-0012-0.
PubMed 16091227Meanwell NA, Kadow JF. Inhibitors of the entry of HIV into host cells. Curr Opin Drug Discov Devel. 2003 Jul;6(4):451-61.
PubMed 12951808Reeves JD, Piefer AJ. Emerging drug targets for antiretroviral therapy. Drugs. 2005;65(13):1747-66. doi: 10.2165/00003495-200565130-00002.
PubMed 16114975Schurmann D et al. SCH D: Antiviral activity of a CCR5 receptor antagonist. 11th Conf Retro and Opportun Infect. 2004 Feb 8-11 (abstract no 140LB).
Shaheen F, Collman RG. Co-receptor antagonists as HIV-1 entry inhibitors. Curr Opin Infect Dis. 2004 Feb;17(1):7-16. doi: 10.1097/00001432-200402000-00003.
PubMed 15090884Strizki JM, Tremblay C, Xu S, Wojcik L, Wagner N, Gonsiorek W, Hipkin RW, Chou CC, Pugliese-Sivo C, Xiao Y, Tagat JR, Cox K, Priestley T, Sorota S, Huang W, Hirsch M, Reyes GR, Baroudy BM. Discovery and characterization of vicriviroc (SCH 417690), a CCR5 antagonist with potent activity against human immunodeficiency virus type 1. Antimicrob Agents Chemother. 2005 Dec;49(12):4911-9. doi: 10.1128/AAC.49.12.4911-4919.2005.
PubMed 16304152Wilkin TJ, Su Z, Kuritzkes DR, Hughes M, Flexner C, Gross R, Coakley E, Greaves W, Godfrey C, Skolnik PR, Timpone J, Rodriguez B, Gulick RM. HIV type 1 chemokine coreceptor use among antiretroviral-experienced patients screened for a clinical trial of a CCR5 inhibitor: AIDS Clinical Trial Group A5211. Clin Infect Dis. 2007 Feb 15;44(4):591-5. doi: 10.1086/511035. Epub 2007 Jan 17.
PubMed 17243065Wilkin 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 20672447Tsibris 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Randomized, Double-Blind Study of the Safety and Efficacy of Vicriviroc (An Orally Administered HIV-1 Entry Inhibitor) in HIV-Infected, Treatment-Experienced Subjects
- ClinicalTrials.gov ID
- NCT00082498
- Acronym / sponsor ID
- A5211
- Conditions
- HIV Infections
- Keywords
- SCH-D, Schering D, Treatment Experienced, Entry Inhibitors, Fusion Inhibitors, Vicriviroc
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Study start
- May 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 12 May 2004 (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.
New treatment options are critical for treatment-experienced HIV infected patients with drug resistance. HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV drugs. This study will test the safety and effectiveness of three different doses of vicriviroc (formerly known as Schering D, SCH-D, or SCH 417690) in HIV infected patients.
Detailed description
Vicriviroc is an oral HIV-1 entry inhibitor that targets the CCR5 receptor of T cells. Vicriviroc has been shown safe, well-tolerated, and active in Phase I clinical trials in treatment-naive HIV infected patients. The goal of this study is to evaluate the antiretroviral activity of three dose levels of vicriviroc in HIV infected, treatment-experienced patients who are failing their current ritonavir-containing antiretroviral therapy (ART).
The study will last at least 48 weeks, but no more than 5 years. There are 3 steps in this study. Patients will be randomly assigned to one of 4 groups. Group 1 will receive placebo; Group 2 will receive 5 mg vicriviroc daily; Group 3 will receive 10 mg vicriviroc daily; and Group 4 will receive 15 mg vicriviroc daily. If at or after Week 16 a participant's viral load has not met certain criteria, a dose increase of vicriviroc may occur and the participant will enter Step 2. As of 10/12/05, patients in Group 2 and any patients who entered Step 2 following virologic failure in Step 1 will be unblinded and offered either 15 mg vicriviroc daily through this study or the option of seeking alternative treatment. All patients will continue their current ART (not provided by the study). After two weeks, patients will receive ART optimized by the results of genotypic/phenotypic testing performed at study screening. All participants who have received or are receiving vicriviroc will enter Step 3 and be followed for an additional 4 years. Participants who complete the study may be eligible to receive vicriviroc through a rollover study sponsored by Schering-Plough, the drug's manufacturer.
Physical exams and blood collection will occur at study entry, Day 4, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Additionally, blood will be drawn twice, at least 2 hours apart, at both Weeks 2 and 8 for vicriviroc pharmacokinetic analysis. Patients will undergo an electrocardiogram (EKG) at Weeks 2, 8, 24, and 48. Patients will be assessed for peripheral neuropathy at study entry and Weeks 24 and 48, and will be asked to complete an adherence questionnaire at entry and Weeks 2, 8, 16, 24, 32, 40, and 48. For Step 3 participants undergoing follow-up, physical exams and blood work will occur every 6 months for 4 years.
Five participants currently enrolled at four sites that are no longer receiving funding and who will not be transferred or redirected to a site within their proximity will be subject to the following changes. There will no longer be follow-up visits per the schedule of events described in the protocol. Instead, participants will have their follow-up limited to self-report through telephone interviews to ascertain vital status, occurrence of malignancies (if any), and collection of information such as HIV-1 RNA and CD4 cell count. For these participants only, the HIV-1 RNA and CD4 cell count will be done as part of the participant's clinical care and will not be paid for by the study. The follow-up telephone interviews will be conducted at six-month intervals using the script provided by the study team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboGroup 1 will receive placebo |
| 2 | Experimental | Drug: SCH-D (vicriviroc)Group 2 will receive 5 mg vicriviroc daily |
| 3 | Experimental | Drug: SCH-D (vicriviroc)Group 3 will receive 10 mg vicriviroc daily |
| 4 | Experimental | Drug: SCH-D (vicriviroc)Group 4 will receive 15 mg vicriviroc daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- HIV infected
- Experiencing virologic failure on current ART regimen
- Current ART regimen contains ritonavir (100 to 800 mg/day) and has been stable for at least 8 weeks prior to study entry. If amprenavir or fosamprenavir is part of the regimen, 200 to 800 mg/day ritonavir must be used for at least 2 weeks prior to study entry.
- Experienced virologic failure on at least one ART regimen containing 3 or more drugs prior to current failing regimen
- CD4 count of 50 cells/mm3 or more within 6 weeks prior to study entry
Key exclusion criteria (20 listed)
- Hepatitis C antibody and RNA positive
- Hepatitis B surface antigen positive
- Efavirenz or nevirapine use within 8 weeks of study entry
- Vaccination within 2 weeks prior to study screening
- Investigational agents within 30 days prior to study entry
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 |
|---|---|---|
| SCH-D (vicriviroc)Group 2 will receive 5 mg vicriviroc daily; Group 3 will receive 10 mg vicriviroc daily; and Group 4 will receive 15 mg vicriviroc daily. If at or after Week 16 a participant's viral load has not met certain criteria, a dose increase of vicriviroc may occur and the participant will enter Step 2. As of 10/12/05, patients in Group 2 and any patients who entered Step 2 following virologic failure in Step 1 will be unblinded and offered either 15 mg vicriviroc daily through this study or the option of seeking alternative treatment. | Drug | 2, 3, 4 |
| PlaceboPatients in Group 1 will receive placebo. | Drug | 1 |
Primary outcome
Change in HIV-1 viral load
Time frame: From baseline to Day 14
6 secondary outcomes
Safety and tolerability
Time frame: Throughout the study
Virologic and immunologic outcomes
Time frame: Throughout the study
Clinical outcomes
Time frame: Throughout the study
Pharmacokinetic outcomes
Time frame: At Weeks 2 and 8
Viral coreceptor phenotype
Time frame: At study entry, Day 4, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Adherence measures
Time frame: At study entry and Weeks 2, 8, 16, 24, 32, 40, and 48
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 1 Nov 2021.
- Background: PubMed 16091227Marks K, Gulick RM. New antiretroviral agents for the treatment of HIV infection. Curr HIV/AIDS Rep. 2004 Jun;1(2):82-8. doi: 10.1007/s11904-004-0012-0.
- Background: PubMed 12951808Meanwell NA, Kadow JF. Inhibitors of the entry of HIV into host cells. Curr Opin Drug Discov Devel. 2003 Jul;6(4):451-61.
- Background: PubMed 16114975Reeves JD, Piefer AJ. Emerging drug targets for antiretroviral therapy. Drugs. 2005;65(13):1747-66. doi: 10.2165/00003495-200565130-00002.
- BackgroundSchurmann D et al. SCH D: Antiviral activity of a CCR5 receptor antagonist. 11th Conf Retro and Opportun Infect. 2004 Feb 8-11 (abstract no 140LB).
- Background: PubMed 15090884Shaheen F, Collman RG. Co-receptor antagonists as HIV-1 entry inhibitors. Curr Opin Infect Dis. 2004 Feb;17(1):7-16. doi: 10.1097/00001432-200402000-00003.
- Background: PubMed 16304152Strizki JM, Tremblay C, Xu S, Wojcik L, Wagner N, Gonsiorek W, Hipkin RW, Chou CC, Pugliese-Sivo C, Xiao Y, Tagat JR, Cox K, Priestley T, Sorota S, Huang W, Hirsch M, Reyes GR, Baroudy BM. Discovery and characterization of vicriviroc (SCH 417690), a CCR5 antagonist with potent activity against human immunodeficiency virus type 1. Antimicrob Agents Chemother. 2005 Dec;49(12):4911-9. doi: 10.1128/AAC.49.12.4911-4919.2005.
- Results publication: PubMed 17243065Wilkin TJ, Su Z, Kuritzkes DR, Hughes M, Flexner C, Gross R, Coakley E, Greaves W, Godfrey C, Skolnik PR, Timpone J, Rodriguez B, Gulick RM. HIV type 1 chemokine coreceptor use among antiretroviral-experienced patients screened for a clinical trial of a CCR5 inhibitor: AIDS Clinical Trial Group A5211. Clin Infect Dis. 2007 Feb 15;44(4):591-5. doi: 10.1086/511035. Epub 2007 Jan 17.
- Derived from this study: 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.
- Derived from this study: 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.
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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.
Roy M. Gulick, MD, MPH study chair
Cornell HIV Clinical Trials Unit
Charles Flexner, MD study chair
Johns Hopkins University Hospital
Daniel Kuritzkes, MD study chair
Harvard Medical School, Partners AIDS Research Center
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCH-D (vicriviroc) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 30 sites in United States.
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 12 inclusion and 20 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. 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. Some participants in this study may receive a placebo. 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?
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?
Change in HIV-1 viral load (time frame: From baseline to Day 14). 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 NCT00082498, which also lists 9 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 1 Nov 2021.