Status:
TERMINATED
Investigation of The Effect of Cenicriviroc (CVC) Plus FTC/TDF on Cardiovascular Disease Risk Factors
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Tobira Therapeutics, Inc.
Conditions:
HIV Infection
Eligibility:
All Genders
18+ years
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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:
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01474954
Start Date
September 1 2011
End Date
December 1 2012
Last Update
May 12 2015
Active Locations (1)
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1
University of California, San Francisco; San Francisco General Hospital
San Francisco, California, United States, 94110