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HIV-1 InfectionPhase 2NCT01338883

Efficacy, Safety, and Tolerability of Cenicriviroc (CVC) in Combination With Truvada or Sustiva Plus Truvada in HIV 1-infected, Antiretroviral Treatment-naïve, Adult Patients Infected With Only CCR5-tropic Virus

A Phase 2 study testing Cenicriviroc 100 mg, Cenicriviroc 200 mg + Truvada and Sustiva + Truvada in people with HIV-1 Infection, run by Tobira Therapeutics, Inc. at 48 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a randomized, double-blind, double-dummy, 48-week, comparative study. Approximately 150 HIV-infected, treatment-naïve patients with CCR5-tropic virus will be stratified by HIV-1 RNA: ≥100,000 copies/mL versus <100,000 copies/mL and will be randomized 2:2:1 to receive: Arm A: CVC 100 mg (2 tablets, 50 mg each)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
Cenicriviroc 100 mg, Cenicriviroc 200 mg + Truvada and Sustiva + Truvada
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
48 sitesin 2 countries
Study dates
Jun 2011to Jun 2013
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

Selected Inclusion Criteria:

  1. Adult male and female, HIV-1-infected patients 18 years old and older.
  2. Body mass index (BMI) 18 to < 35 kg/m2.
  3. Antiretroviral treatment-naïve. Treatment-naïve is defined as:
  • No prior nonnucleoside 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.
  1. HIV-1 CCR5-tropic-only virus.
  2. Plasma HIV-1 RNA level >/=1,000 copies/mL at first Screening.
  3. CD4 cell count >/=250 cells/mm3 at first Screening.

Selected Exclusion Criteria:

  1. Presence of CXCR4- or dual/mixed-tropic HIV-1 virus.
  2. Presence of primary resistance mutations or phenotypic resistance to TDF, FTC, or EFV and/or mutations associated with multidrug nucleoside/nucleotide resistance.
  3. An active CDC category C disease (except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial).
  4. Any historical CD4 count < 200 cells/mm3.
  5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value Grade > 2 or total bilirubin greater than the upper limit of normal (ULN).
  6. 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.

Trial locations and contacts

48 sites in 2 countries.

48 sites in 2 countries

United States45 sites

  • AIDS Research Consortium of Atlanta, Inc.

    Atlanta, Georgia, 30308

  • AIDS Healthcare Foundation Research Center

    Beverly Hills, California, 90211

  • Pacific Oaks Medical Group

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Community Research Initiative of New England

    Boston, Massachusetts, 02215

  • Synergy First Medical PLLC

    Brooklyn, New York, 11230

  • Erie County Medical Center Corporation

    Buffalo, New York, 14215

  • Providence Clinical Research

    Burbank, California, 91505

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0405

  • North Texas Infectious Diesease Consultants

    Dallas, Texas, 75246

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Gary Richmond

    Fort Lauderdale, Florida, 33316

  • Midway Immunology and Research Center

    Ft. Pierce, Florida, 34982

  • ID Care

    Hillsborough, New Jersey, 08844

  • Therapeutic Concepts

    Houston, Texas, 77004

  • The University of Texas Health Science Center at Houston Medical School

    Houston, Texas, 77030

  • Rosedale Infectious Disease

    Huntersville, North Carolina, 28078

  • AIDS Research Alliance

    Los Angeles, California, 90015

  • Peter J Ruane MD Incorporated

    Los Angeles, California, 90036

  • Oasis Clinic

    Los Angeles, California, 90059

  • Anthony Mills

    Los Angeles, California, 90069

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Care Resource Inc.

    Miami, Florida, 33137

  • Kinder Medical Group

    Miami, Florida, 33137

  • Wohlfeiler, Piperato & Associates, LLC

    Miami Beach, Florida, 33139

  • Bisher Akil, M.D., A Medical Corporation

    New York, New York, 10011

  • Aaron Diamond AIDS Research Center

    New York, New York, 10016

  • ACRIA

    New York, New York, 10018

  • Jacobi Medical Center

    New York, New York, 10461

  • Orange Coast Medical Group

    Newport Beach, California, 92663

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Stanford University ACTU

    Palo Alto, California, 94304

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Southwest Center for HIV / AIDS

    Phoenix, Arizona, 85006

  • AIDS Care

    Rochester, New York, 14607

  • Health Positive

    Safety Harbor, Florida, 34695

  • University of California at San Francisco

    San Francisco, California, 94110

  • Quest Clinical Research

    San Francisco, California, 94115

  • Chatham County Health Department

    Savannah, Georgia, 31410

  • Treasure Coast Infectious Disease Consultants

    Vero Beach, Florida, 32960

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Whitman-Walker Clinic

    Washington D.C., District of Columbia, 20009

  • Triple O Research Institute, PA

    West Palm Beach, Florida, 33401

Other trials in United States

Puerto Rico3 sites

  • Univ. of Puerto Rico - ACTU

    San Juan, PR, 935

  • University of Puerto Rico, School of Medicine, CEMI

    San Juan, PR, 935

  • Clinical Research P.R., Inc.

    Santurce, Puerto Rico, 909

Other trials in Puerto Rico

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 randomized, double-blind, double-dummy, 48-week, comparative study. Approximately 150 HIV-infected, treatment-naïve patients with CCR5-tropic virus will be stratified by HIV-1 RNA: ≥100,000 copies/mL versus <100,000 copies/mL and will be randomized 2:2:1 to receive:

  • Arm A: CVC 100 mg (2 tablets, 50 mg each) QD + CVC matching placebo (2 tablets) QD + EFV matching placebo (1 tablet) QHS + FTC/TDF (1 tablet) QD.
  • Arm B: CVC 200 mg (4 tablets, 50 mg each) QD + EFV matching placebo (1 tablet) QHS + FTC/TDF (1 tablet) QD.
  • Arm C: CVC matching placebo (4 tablets) QD + EFV 600 mg (1 tablet) QHS + FTC/TDF (1 tablet) QD.
Read more

Doses of both CVC/placebo and EFV/ placebo will be administered as double-blinded study drug. FTC/TDF will be administered as open-label study drug in a fixed-dose combination formulation (Truvada). CVC/placebo should be taken following breakfast; EFV should be taken on an empty stomach at bedtime.

HIV-1 RNA levels and CD4+ and CD8+ cell counts, percentages, and ratios will be measured at every visit. Samples for viral tropism and resistance testing in case of virologic failure will be collected at Screening and each on-treatment visit.

Biomarkers associated with inflammation and immune activation will be measured at Baseline (predose) and each study visit thereafter, with flow cytometry obtained at weeks 4, 12, 24, 48, and 52.

Fasting metabolic indicators of glucose control (glucose and insulin for HOMA-IR, HbA1c) and fasting lipid profiles (HDL, LDL, total cholesterol, and triglycerides) will be measured at Baseline (predose) and Weeks 4, 12, 24, 48, and 52. Waist-to-hip ratios will be measured at Baseline and Weeks 24 and 48.

Plasma samples will be collected and stored for possible future studies at Baseline (predose) and every visit thereafter.

Conditions
HIV-1 Infection
Being tested
Cenicriviroc 100 mg, Cenicriviroc 200 mg + Truvada, Sustiva + Truvada
Keywords
HIV-1 Infection, CCR5-tropic, Anti-retroviral naive

What participants receive

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

  • Cenicriviroc 100 mgDrug

    100 mg CVC plus Truvada

  • Cenicriviroc 200 mg + TruvadaDrug

    200 mg CVC plus Truvada

  • Sustiva + TruvadaDrug

    Sustiva plus Truvada

Study groups in NCT01338883
Study groupRoleWhat they receive
CVC 100 mg + TruvadaExperimentalNot described
Receives: Drug: Cenicriviroc 100 mg
CVC 200 mg + TruvadaExperimentalNot described
Receives: Drug: Cenicriviroc 200 mg + Truvada
Sustiva + TruvadaActive comparatorNot described
Receives: Drug: Sustiva + Truvada

What is being measured

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

  1. To determine the percentage of patients who achieve HIV-1 RNA levels below 50 copies/mL at Week 24

    Measured: 24 weeks

Timeline

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

  1. First posted20 Apr 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionDec 2012
  4. Study completionJun 2013

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01338883
Sponsor's protocol ID
TBR-652-2-202
Status last verified
Jul 2013
First submitted
18 Apr 2011
Last updated
10 Jul 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Sherman KE, Abdel-Hameed E, Rouster SD, Shata MTM, Blackard JT, Safaie P, Kroner B, Preiss L, Horn PS, Kottilil S. Improvement in Hepatic Fibrosis Biomarkers Associated With Chemokine Receptor Inactivation Through Mutation or Therapeutic Blockade. Clin Infect Dis. 2019 May 17;68(11):1911-1918. doi: 10.1093/cid/ciy807.

    PubMed 30239650

  • Thompson M, Saag M, DeJesus E, Gathe J, Lalezari J, Landay AL, Cade J, Enejosa J, Lefebvre E, Feinberg J. A 48-week randomized phase 2b study evaluating cenicriviroc versus efavirenz in treatment-naive HIV-infected adults with C-C chemokine receptor type 5-tropic virus. AIDS. 2016 Mar 27;30(6):869-78. doi: 10.1097/QAD.0000000000000988.

    PubMed 26636929

  • Kagan RM, Johnson EP, Siaw MF, Van Baelen B, Ogden R, Platt JL, Pesano RL, Lefebvre E. Comparison of genotypic and phenotypic HIV type 1 tropism assay: results from the screening samples of Cenicriviroc Study 202, a randomized phase II trial in treatment-naive subjects. AIDS Res Hum Retroviruses. 2014 Feb;30(2):151-9. doi: 10.1089/AID.2013.0123. Epub 2013 Aug 14.

    PubMed 23875707

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cenicriviroc 100 mg, Cenicriviroc 200 mg + Truvada and Sustiva + Truvada in people with HIV-1 Infection, run by Tobira Therapeutics, Inc. at 48 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 10 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, Puerto Rico. 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.

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?

To determine the percentage of patients who achieve HIV-1 RNA levels below 50 copies/mL at Week 24 (time frame: 24 weeks). 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 NCT01338883, 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 10 Jul 2013.

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