HIV InfectionNCT01474954
Investigation of The Effect of Cenicriviroc (CVC) Plus FTC/TDF on Cardiovascular Disease Risk Factors
An observational study of HIV Infection, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a single-site substudy, "Investigation of the Effect of Cenicriviroc (CVC) plus Emtricitabine/Tenofovir (FTC/TDF) on Atherosclerosis Risk Factors", open to all patients enrolled in the primary study, "A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2012
- 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: All primary study participants who received at least one dose of study drug and had data from both a Baseline and at least 1 post-Baseline vis.t
Who may be able to join
- Adult male and female, HIV-1-infected patients 18 years old and older.
- Body mass index (BMI) 18 to <=35 kg/m2
- Antiretroviral treatment-naive (no prior non-nucleoside reverse transcriptase inhibitor, other than in women who received a single dose of perinatal nevirapine who have no K103 viral mutation, no prior CCR5 antagonist therapy, no more than 10 days of any other prior antiretroviral therapy)
- HIV-1 CCR5-tropic-only virus, as determined on both a tropism genotype and the enhanced Trofile assay
- Plasma HIV-1 RNA level >= 1,000 copies/mL at Screening Visit 1
- CD4 count >= 250 cells/mm3 at Screening Visit 1
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- Able and willing to provide written informed consent
- Willing to take appropriate precautions to prevent pregnancy
- Women of child-bearing potential may be enrolled following a negative urine pregnancy test. If participating in activity that could lead to pregnancy, men and women must agree to use two forms of barrier method contraception during the trial and for 3 months after stopping the medication.
- Women who are not of reproductive potential (documented to be surgically sterile or postmenopausal [defined as amenorrhea >= 1 year and follicle stimulating hormone>= 30 mU/mL]) are eligible to be enrolled
- Signed informed consent for participation in the sub-study
Who cannot join
- Presence of CXCR4- or dual/mixed-tropic HIV-1 virus on either the enhanced Trofile assay or a tropism genotype
- Presence of primary resistance mutations or phenotypic resistance to TDF, FTC, or EFV and/or mutations associated with multidrug nucleoside/nucleoside resistance
- An active CDC category C disease (except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial)
- Any historical CD4 count <200 cells/mm3
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value Grade >=2 or total bilirubin greater than the upper limit of normal (ULN) during Screening
- History of HIV-2, hepatitis B and/or C, cirrhosis of the liver, or any known active or chronic liver disease. Hepatitis B vaccinated patients are eligible, as follows:
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- Patients with a recent history of hepatitis B (positive hepatitis B surface antigen [HBsAg]) are excluded.
- Patients with prior exposure to hepatitis B but with no virus present (positive hepatits B surface antibody [HBsAb]) are eligible provided liver function tests (AST and ALT) are within normal ranges, the patient has no signs/symptoms of hepatitis, and all other entry criteria are met.
- Patients with positive hepatitis B core antibody (HBcAb) may be chronic carriers of hepatitis B or have cleared the virus and are eligible provided liver function tests (AST and ALT) are completely normal, the patient has no signs/symptoms of hepatitis, and all other entry criteria are met.
- Patients with positive hepatitis C antibody (HCVAb) are excluded, except those with proof of viral clearance and normal liver function tests (LFTs) may be eligible with Medical Monitor approval.
- A current diagnosis of tuberculosis (TB) infection, any prior untreated TB infection, inadequate treatment of active TB, or inadequate treatment for a positive purified protein derivative (PPD) test. Cases of active infection and latent TB infection with a documented history of adequate treatment may be considered for enrollment provided the subject has a negative chest x-ray following treatment and within 6 months before randomization. Adequate treatment is defined as meeting the current recommendations of the Centers for Disease Control and Prevention (CDC). National Institutes of Health (NIH), and the HIV Medicine Association of the Infectious Diseases Society of America (IDSA) guidelines, or other CDC recommendations if the patient was treated before the current recommendations or before coinfection with HIV. Investigators are encouraged to discuss such cases with the Medical Monitor if in doubt as to patient eligibility.
- Any prior or current diagnosis with other intracellular pathogens.
- Recent history (<30 days) of clinically significant infection or illness.
- Pregnancy or breastfeeding
- Current or anticipated treatment with immunmodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity
- Immunization within 30 days of first dose of investigational study drug.
- Current alcohol or durg use, which in the expert judgment of the Investigator, will interfere with the patient's ability to comply with the protocol requirements.
- Any experimental medication within 30 days prior to Screening or anticipated use during the trial.
- Current (within 5 half-lives or 14 days prior to the first dose of study drug, whichever is longer) or anticipated use of antimetabolites; alkylating agents; or drugs, herbal preparations (including St. John's wort), and foods (including grapefruit) known to affect the cytochrom P450 (CYP) family CYP 3A4 or CYP 2C8 enzymes or P-glycoprotein (P-gp) transporters.
- Use of over-the counter (OTC) medications as follows:
- In the first 25 patients, any systemic OTC preparations, including herbal preparations (e.g. phytotherapeutic, herbal, or plant-derived preparations), within 14 days prior to the first dose of study medication)
- After the first 25 patients, systemic OTC herbal medications (including phytotherapeutic, herbal, or plant-derived preparations) within 14 days prior to the first dose of study medication, unless approved by the Investigator.
- After the first 25 patients, chronically needed OTC medications, unless discussed with and approved by the Medical Monitor
- History of clinically significant metabolic, endocrine, hepatic, renal, hematologic, pulmonary, gastrointestinal, or cardiovascular disorders.
- Uncontrolled hypertension (i.e. systolic blood pressure [BP] >=140 or diastolic BP >= 90)
- Bradycardia, defined as sinus rhythm <50 beats/min (bpm)
- History or presence of an abnormal electrocardiogram (ECG)
- Presence of any condition that would interfere with the absorption, distribution, metabolism, or excretion of the drug.
- After the first 25 patients enrolled, adequately controlled conditions such as gastroesophageal reflux disease (GERD) may be allowed. Investigators are encouraged to discuss such cases with the Medical Monitor if in doubt as to patient eligibility.
- History of malignancy except cured basal or squamous cell carcinoma of the skin
- Patients who have received radiation or cytotoxic chemotherapeutic agents, unless fully recovered by the time of the first dose of study drug, or who may require them during the study period.
- Patients who are, in the opinion of the Investigator, unable to comply with the dosing schedule and protocol evaluations.
- Inability to access the research clinic.
- Inability, in the judgement of the investigator, to comply with the additional requirements of the sub-study.
- Starting, stopping, or changing lipid-lowering antihypertensive medications within the 12 weeks before study entry.
- Persistent resting blood pressure of less than 100/70 mm Hg.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco; San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR-652) or Once-Daily EFV, Each With Open-Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With Only CCR5-Tropic Virus
This is a single-site substudy, "Investigation of the Effect of Cenicriviroc (CVC) plus Emtricitabine/Tenofovir (FTC/TDF) on Atherosclerosis Risk Factors", open to all patients enrolled in the primary study, "A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR-652) or Once-Daily EFV, Each With Open-Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With Only CCR5-Tropic Virus", in the San Francisco Bay area to evaluate changes in brachial flow mediated dilation in patients in one of three treatment groups: 1. Cenicriviroc (CVC) at 100mg (2 tablets, 50mg each) QD + CVC matching placebo (2 tablets) QD + Efavirenz (EFV) matching placebo (1 capsule) QHS + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (1 tablet) QD; 2. CVC at 200mg (4 tablets, 50mg each) QD + EFV matching placebo (1 capsule) QHS + FTC/TDF (1 tablet) QD; 3. CVC matching placebo (4 tablets) QD + EFV 600 mg (1 capsule) QHS + FTC/TDF (1 tablet) QD. The substudy will run for the duration of the primary study. 50 patients of the 150 total enrolled in the primary study will be referred to and enrolled in the cardiovascular substudy.
Patients enrolled in the substudy and substudy protocol staff will be blinded to study treatment. Data obtained on this substudy will be analyzed in conjunction with laboratory data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary study.
The primary study is a randomized, double-blind, double-dummy, 48-week, comparative study in approximately 150 HIV-1-infected, treatment-naïve patients with CCR5-tropic virus. Patients will be stratified by Screening HIV-1 RNA level (≥100,000 copies/mL versus <100,000 copies/mL) and randomized 2:2:1 to one of the three treatment groups. Patients will receive all medications from the primary study, and thus the primary study site will be responsible for any adverse outcomes with the drug.
Read the detailed description
This is a single-site substudy, "Investigation of the Effect of Cenicriviroc (CVC) plus Emtricitabine/Tenofovir (FTC/TDF) on Atherosclerosis Risk Factors", open to all patients enrolled in the primary study, "A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR-652) or Once-Daily EFV, Each With Open-Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With Only CCR5-Tropic Virus", in the San Francisco Bay area to evaluate changes in brachial flow mediated dilation in patients in one of three treatment groups: 1. Cenicriviroc (CVC) at 100mg (2 tablets, 50mg each) QD + CVC matching placebo (2 tablets) QD + Efavirenz (EFV) matching placebo (1 capsule) QHS + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (1 tablet) QD; 2. CVC at 200mg (4 tablets, 50mg each) QD + EFV matching placebo (1 capsule) QHS + FTC/TDF (1 tablet) QD; 3. CVC matching placebo (4 tablets) QD + EFV 600 mg (1 capsule) QHS + FTC/TDF (1 tablet) QD. The substudy will run for the duration of the primary study. 50 patients of the 150 total enrolled in the primary study will be referred to and enrolled in the cardiovascular substudy.
Patients enrolled in the substudy and substudy protocol staff will be blinded to study treatment. Data obtained on this substudy will be analyzed in conjunction with laboratory data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary study.
The primary study is a randomized, double-blind, double-dummy, 48-week, comparative study in approximately 150 HIV-1-infected, treatment-naïve patients with CCR5-tropic virus. Patients will be stratified by Screening HIV-1 RNA level (≥100,000 copies/mL versus <100,000 copies/mL) and randomized 2:2:1 to one of the three treatment groups. Patients will receive all medications from the primary study, and thus the primary study site will be responsible for any adverse outcomes with the drug.
Primary Objective:
- To assess changes from Baseline in brachial artery vascular patency after 24 weeks of treatment with a CVC containing regimen.
Secondary Objectives:
- To compare changes from Baseline in vascular patency and after 48 weeks of treatment with CVC versus EFV.
- To assess changes from Baseline to Weeks 4, 12, 24, and final follow-up in vascular patency.
- To assess changes from Baseline to Week 48 in flow-mediated dilation (FMD) in relation to immunologic and metabolic covariates.
- Conditions
- HIV Infection
- Keywords
- HIV, Antiretroviral Medication, Cardiovascular Disease Risk
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess changes from Baseline in brachial artery vascular patency after 24 weeks of treatment with a CVC containing regimen.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobira Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Priscilla Hsue, MD, Principal investigator, San Francisco General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474954
- Sponsor's protocol ID
- 652-2-202
- Status last verified
- May 2015
- First submitted
- 15 Nov 2011
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR-652) or Once-Daily EFV, Each With Open-Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With Only CCR5-Tropic Virus
- ClinicalTrials.gov ID
- NCT01474954
- Acronym / sponsor ID
- 652-2-202
- Conditions
- HIV Infection
- Keywords
- HIV, Antiretroviral Medication, Cardiovascular Disease Risk
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobira Therapeutics, Inc.
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Nov 2011 (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 a single-site substudy, "Investigation of the Effect of Cenicriviroc (CVC) plus Emtricitabine/Tenofovir (FTC/TDF) on Atherosclerosis Risk Factors", open to all patients enrolled in the primary study, "A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR-652) or Once-Daily EFV, Each With Open-Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With Only CCR5-Tropic Virus", in the San Francisco Bay area to evaluate changes in brachial flow mediated dilation in patients in one of three treatment groups: 1. Cenicriviroc (CVC) at 100mg (2 tablets, 50mg each) QD + CVC matching placebo (2 tablets) QD + Efavirenz (EFV) matching placebo (1 capsule) QHS + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (1 tablet) QD; 2. CVC at 200mg (4 tablets, 50mg each) QD + EFV matching placebo (1 capsule) QHS + FTC/TDF (1 tablet) QD; 3. CVC matching placebo (4 tablets) QD + EFV 600 mg (1 capsule) QHS + FTC/TDF (1 tablet) QD. The substudy will run for the duration of the primary study. 50 patients of the 150 total enrolled in the primary study will be referred to and enrolled in the cardiovascular substudy.
Patients enrolled in the substudy and substudy protocol staff will be blinded to study treatment. Data obtained on this substudy will be analyzed in conjunction with laboratory data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary study.
The primary study is a randomized, double-blind, double-dummy, 48-week, comparative study in approximately 150 HIV-1-infected, treatment-naïve patients with CCR5-tropic virus. Patients will be stratified by Screening HIV-1 RNA level (≥100,000 copies/mL versus <100,000 copies/mL) and randomized 2:2:1 to one of the three treatment groups. Patients will receive all medications from the primary study, and thus the primary study site will be responsible for any adverse outcomes with the drug.
Detailed description
This is a single-site substudy, "Investigation of the Effect of Cenicriviroc (CVC) plus Emtricitabine/Tenofovir (FTC/TDF) on Atherosclerosis Risk Factors", open to all patients enrolled in the primary study, "A Phase 2b Randomized, Double-Blind, Double-Dummy Trial of 100 or 200 mg Once-Daily Doses of Cenicriviroc (CVC, TBR-652) or Once-Daily EFV, Each With Open-Label FTC/TDF, in HIV-1-Infected, Antiretroviral Treatment-Naïve, Adult Patients With Only CCR5-Tropic Virus", in the San Francisco Bay area to evaluate changes in brachial flow mediated dilation in patients in one of three treatment groups: 1. Cenicriviroc (CVC) at 100mg (2 tablets, 50mg each) QD + CVC matching placebo (2 tablets) QD + Efavirenz (EFV) matching placebo (1 capsule) QHS + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (1 tablet) QD; 2. CVC at 200mg (4 tablets, 50mg each) QD + EFV matching placebo (1 capsule) QHS + FTC/TDF (1 tablet) QD; 3. CVC matching placebo (4 tablets) QD + EFV 600 mg (1 capsule) QHS + FTC/TDF (1 tablet) QD. The substudy will run for the duration of the primary study. 50 patients of the 150 total enrolled in the primary study will be referred to and enrolled in the cardiovascular substudy.
Patients enrolled in the substudy and substudy protocol staff will be blinded to study treatment. Data obtained on this substudy will be analyzed in conjunction with laboratory data for cardiovascular disease risk factors and HIV-1 RNA levels obtained on the primary study.
The primary study is a randomized, double-blind, double-dummy, 48-week, comparative study in approximately 150 HIV-1-infected, treatment-naïve patients with CCR5-tropic virus. Patients will be stratified by Screening HIV-1 RNA level (≥100,000 copies/mL versus <100,000 copies/mL) and randomized 2:2:1 to one of the three treatment groups. Patients will receive all medications from the primary study, and thus the primary study site will be responsible for any adverse outcomes with the drug.
Primary Objective:
- To assess changes from Baseline in brachial artery vascular patency after 24 weeks of treatment with a CVC containing regimen.
Secondary Objectives:
- To compare changes from Baseline in vascular patency and after 48 weeks of treatment with CVC versus EFV.
- To assess changes from Baseline to Weeks 4, 12, 24, and final follow-up in vascular patency.
- To assess changes from Baseline to Week 48 in flow-mediated dilation (FMD) in relation to immunologic and metabolic covariates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All primary study participants who received at least one dose of study drug and had data from both a Baseline and at least 1 post-Baseline vis.t
Key inclusion criteria (11 listed)
- Adult male and female, HIV-1-infected patients 18 years old and older.
- Body mass index (BMI) 18 to <=35 kg/m2
- Antiretroviral treatment-naive (no prior non-nucleoside reverse transcriptase inhibitor, other than in women who received a single dose of perinatal nevirapine who have no K103 viral mutation, no prior CCR5 antagonist therapy, no more than 10 days of any other prior antiretroviral therapy)
- HIV-1 CCR5-tropic-only virus, as determined on both a tropism genotype and the enhanced Trofile assay
- Plasma HIV-1 RNA level >= 1,000 copies/mL at Screening Visit 1
Key exclusion criteria (36 listed)
- Presence of CXCR4- or dual/mixed-tropic HIV-1 virus on either the enhanced Trofile assay or a tropism genotype
- Presence of primary resistance mutations or phenotypic resistance to TDF, FTC, or EFV and/or mutations associated with multidrug nucleoside/nucleoside resistance
- An active CDC category C disease (except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial)
- Any historical CD4 count <200 cells/mm3
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value Grade >=2 or total bilirubin greater than the upper limit of normal (ULN) during Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess changes from Baseline in brachial artery vascular patency after 24 weeks of treatment with a CVC containing regimen.
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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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.
Priscilla Hsue, MD principal investigator
San Francisco General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by University of California, San Francisco at 1 site 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 11 inclusion and 36 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: stopped early, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
To assess changes from Baseline in brachial artery vascular patency after 24 weeks of treatment with a CVC containing regimen. (time frame: 24 weeks). 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 12 May 2015.