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
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| ClinicalTrials.gov Identifier: NCT01338883 |
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Recruitment Status :
Completed
First Posted : April 20, 2011
Last Update Posted : July 10, 2013
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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 |
|---|---|---|
| HIV-1 Infection | Drug: Cenicriviroc 100 mg Drug: Cenicriviroc 200 mg + Truvada Drug: Sustiva + Truvada | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | June 2011 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | June 2013 |
| 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 |
- To determine the percentage of patients who achieve HIV-1 RNA levels below 50 copies/mL at Week 24 [ Time Frame: 24 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Selected Inclusion Criteria:
- Adult male and female, HIV-1-infected patients 18 years old and older.
- Body mass index (BMI) 18 to < 35 kg/m2.
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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.
- HIV-1 CCR5-tropic-only virus.
- Plasma HIV-1 RNA level >/=1,000 copies/mL at first Screening.
- CD4 cell count >/=250 cells/mm3 at first Screening.
Selected Exclusion Criteria:
- Presence of CXCR4- or dual/mixed-tropic HIV-1 virus.
- Presence of primary resistance mutations or phenotypic resistance to TDF, FTC, or EFV and/or mutations associated with multidrug nucleoside/nucleotide 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01338883
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| Responsible Party: | Tobira Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01338883 |
| Other Study ID Numbers: |
TBR-652-2-202 |
| First Posted: | April 20, 2011 Key Record Dates |
| Last Update Posted: | July 10, 2013 |
| Last Verified: | July 2013 |
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HIV-1 Infection CCR5-tropic Anti-retroviral naive |
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Infection Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Efavirenz TAK-652 Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents |
Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers CCR5 Receptor Antagonists |