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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

Sponsor
Tobira Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01338883
Collaborator
(none)
143
Enrollment
48
Locations
3
Arms
24
Duration (Months)
3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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) 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.

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Cenicriviroc 100 mg
  • Drug: Cenicriviroc 200 mg + Truvada
  • Drug: Sustiva + Truvada
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
143 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: CVC 100 mg + Truvada

Drug: Cenicriviroc 100 mg
100 mg CVC plus Truvada
Experimental: CVC 200 mg + Truvada

Drug: Cenicriviroc 200 mg + Truvada
200 mg CVC plus Truvada
Active Comparator: Sustiva + Truvada

Drug: Sustiva + Truvada
Sustiva plus Truvada

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294
2 Southwest Center for HIV / AIDS Phoenix Arizona United States 85006
3 AIDS Healthcare Foundation Research Center Beverly Hills California United States 90211
4 Pacific Oaks Medical Group Beverly Hills California United States 90211
5 Providence Clinical Research Burbank California United States 91505
6 AIDS Research Alliance Los Angeles California United States 90015
7 Peter J Ruane MD Incorporated Los Angeles California United States 90036
8 Oasis Clinic Los Angeles California United States 90059
9 Anthony Mills Los Angeles California United States 90069
10 Orange Coast Medical Group Newport Beach California United States 92663
11 Stanford University ACTU Palo Alto California United States 94304
12 University of California at San Francisco San Francisco California United States 94110
13 Quest Clinical Research San Francisco California United States 94115
14 Georgetown University Hospital Washington District of Columbia United States 20007
15 Whitman-Walker Clinic Washington District of Columbia United States 20009
16 Midway Immunology and Research Center Fort Pierce Florida United States 34982
17 Therafirst Medical Center Ft. Lauderdale Florida United States 33308
18 Gary Richmond Ft. Lauderdale Florida United States 33316
19 Wohlfeiler, Piperato & Associates, LLC Miami Beach Florida United States 33139
20 University of Miami School of Medicine Miami Florida United States 33136
21 Care Resource Inc. Miami Florida United States 33137
22 Kinder Medical Group Miami Florida United States 33137
23 Orlando Immunology Center Orlando Florida United States 32803
24 Health Positive Safety Harbor Florida United States 34695
25 Treasure Coast Infectious Disease Consultants Vero Beach Florida United States 32960
26 Triple O Research Institute, PA West Palm Beach Florida United States 33401
27 AIDS Research Consortium of Atlanta, Inc. Atlanta Georgia United States 30308
28 Chatham County Health Department Savannah Georgia United States 31410
29 Community Research Initiative of New England Boston Massachusetts United States 02215
30 Henry Ford Health System Detroit Michigan United States 48202
31 ID Care Hillsborough New Jersey United States 08844
32 Synergy First Medical PLLC Brooklyn New York United States 11230
33 Erie County Medical Center Corporation Buffalo New York United States 14215
34 Jacobi Medical Center New York City New York United States 10461
35 Bisher Akil, M.D., A Medical Corporation New York New York United States 10011
36 Aaron Diamond AIDS Research Center New York New York United States 10016
37 ACRIA New York New York United States 10018
38 AIDS Care Rochester New York United States 14607
39 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
40 Rosedale Infectious Disease Huntersville North Carolina United States 28078
41 University of Cincinnati Cincinnati Ohio United States 45267-0405
42 University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104
43 North Texas Infectious Diesease Consultants Dallas Texas United States 75246
44 Therapeutic Concepts Houston Texas United States 77004
45 The University of Texas Health Science Center at Houston Medical School Houston Texas United States 77030
46 Univ. of Puerto Rico - ACTU San Juan Puerto Rico 935
47 University of Puerto Rico, School of Medicine, CEMI San Juan Puerto Rico 935
48 Clinical Research P.R., Inc. Santurce Puerto Rico 909

Sponsors and Collaborators

  • Tobira Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tobira Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01338883
Other Study ID Numbers:
  • TBR-652-2-202
First Posted:
Apr 20, 2011
Last Update Posted:
Jul 10, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Tobira Therapeutics, Inc.
HIV-1 Infection
CCR5-tropic
Anti-retroviral naive
Additional relevant MeSH terms:
Infections
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Efavirenz
Cenicriviroc

Study Results

No Results Posted as of Jul 10, 2013