Status:
COMPLETED
Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV/AIDS
Antiviral Toxicity
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Increased comorbidities such as cardiovascular disease (CVD), are emerging problems in HIV infection but the mechanisms are unclear. Understanding how antiretrovirals can minimize morbidity in treated...
Detailed Description
Increased comorbidities such as cardiovascular disease (CVD), bone and kidney disease are emerging problems in HIV infection but the mechanisms are unclear. Understanding how antiretrovirals can minim...
Eligibility Criteria
Inclusion
- Inclusion criteria for HIV negative participants
- All HIV negative participants must meet the following criteria:
- 18 years of age or older
- Understands and agrees to local STI reporting requirements
- HIV negative at screening by self-report, with no significant medical diagnoses
- HIV negative by both HIV antibody and HIV PCR in blood (samples obtained during Visit 1)
- Able and willing to communicate in English
- Able and willing to provide written informed consent to take part in the study
- Able and willing to provide adequate information for locator purposes
- Able and willing to provide medical/surgical history
- Availability to return for all study visits, barring unforeseen circumstances
- Willing to abstain from insertion of anything (drug, enema, penis or sex toy) in rectum for 12 hours before and 72 hours after each flexible sigmoidoscopy
- In addition to the criteria listed above, female participants must meet the following criteria
- Negative pregnancy test
- Post-menopausal or using and acceptable form of contraception (e.g. barrier method, IUD, hormonal contraception, or surgical sterilization).
- HIV participant inclusion criteria
- Specific enrollment inclusion criteria include:
- 18 years of age or older
- Cases: Chronically infected and on anti-retroviral therapy with suppressed viremia (viral RNA \<50 copies per ml)
- On stable antiretroviral therapy for 6 months with either a) Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg; E/C/F/TDF)
- Adequate renal function determined by the Cockcroft-Gault formula for creatinine clearance (\>60 mL/min/1.73 m2
- Controls: HIV negative as documented in prior tests and willing to undergo repeat HIV testing
- Able and willing to communicate in English
- Able and willing to provide written informed consent to take part in the study
Exclusion
- Exclusion criteria for all study participants:
- Participants who meet any of the following criteria at screening will be excluded from the study:
- History of chronic inflammatory bowel disease, radiation proctitis or other chronic gastrointestinal disease, exclusive of functional bowel disease (irritable bowel syndrome)
- History of significant gastrointestinal bleeding
- History of a bleeding disorder
- History of colostomy
- History of auto-immune diseases
- Chronic viral hepatitis
- History of diabetes
- History of chemotherapy (for cancer or organ transplantation)
- The chronic or recent (\~2 weeks) use of antimitotic drugs, sulfonamides or antibiotics
- History of or current coagulopathy and/or on anticoagulant therapy
- Anticipated use or unwillingness to abstain from use of aspirin, NSAIDS or any other drugs (including over the counter products) that are associated with the increased likelihood of bleeding
- Active rectal infection (gonorrhea, chlamydia trachomatis, or HSV)
- Positive STI at screening (urine NAAT)
- o Participants will be allowed one re-screening visit after appropriate STI treatment
- History of underlying cardiac arrhythmia or renal disease
- History of severe recent cardiac or pulmonary event
- \> Grade 2 laboratory abnormality at baseline that can not be documented as stable /chronic for that individual
- Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological or cerebral disease.
- Pregnancy
- Breastfeeding
- Female of child-bearing potential unwilling to use acceptable form of contraception
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03251144
Start Date
April 1 2019
End Date
July 1 2021
Last Update
May 10 2022
Active Locations (1)
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1
UCLA CARE Center
Los Angeles, California, United States, 90035