Evaluation of the Cellular Pharmacology of Tenofovir and Emtricitabine According to HIV Infection Status
NCT ID: NCT01040091
Last Updated: 2016-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
34 participants
INTERVENTIONAL
2009-12-31
2014-04-30
Brief Summary
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Detailed Description
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The study duration is 60 days. Study visits will occur at baseline and on Days 1, 3, 7, 20, 30, and 60. At most study visits, participants will undergo blood and urine collection for pharmacology studies, a medication history review, and an adverse effects questionnaire. HIV-uninfected participants will also attend two additional study visits at Days 35 and 45 - while off study medication - for blood and urine collection, adverse effects questionnaires, and a medication history review. At varying study visits during the first 30 days, all participants will undergo one rectal biopsy, female participants will undergo one cervical cell and fluid sampling procedure, and male participants will provide one semen sample. In addition to the collections from enrolled participants, study researchers will also analyze previously collected and stored blood samples from participants in the "Chemoprophylaxis for HIV Prevention in Men (iPrEx)" study, which examined the use of TDF and FTC for the prevention of HIV in men who have sex with men (MSM).
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HIV-Infected Participants
HIV-infected participants will receive FTC, TDF, and EFV for 60 days by prescription from their physicians. Participants will receive Truvada (FTC/TDF) and EFV for the first 30 days. After Day 30, participants may switch to the TDF/FTC/EFV co-formulation through Day 60 as directed by their physician.
Emtricitabine (FTC)
200 mg once a day
Tenofovir disoproxil fumarate (TDF)
300 mg once a day
Efavirenz (EFV)
600 mg once a day
Truvada
200 mg emtricitabine + 300 mg TDF once a day
HIV-Uninfected Participants
HIV-uninfected participants will receive Truvada (FTC/TDF) for 30 days.
Truvada
200 mg emtricitabine + 300 mg TDF once a day
Interventions
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Emtricitabine (FTC)
200 mg once a day
Tenofovir disoproxil fumarate (TDF)
300 mg once a day
Efavirenz (EFV)
600 mg once a day
Truvada
200 mg emtricitabine + 300 mg TDF once a day
Eligibility Criteria
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Inclusion Criteria
* Ability to comply with the study procedures
* HIV-infected adults (HIV documented in medical record or by the primary clinician)
* Clinician/participant plan to initiate TDF/FTC/EFV therapy and agree to separate TDF/FTC and EFV prescriptions for the initial 30 days of the study
* Ability to provide informed consent
* Ability to comply with the study procedures
Exclusion Criteria
* Positive screening test for hepatitis B (HBV) infection
* Pregnant or planning to become pregnant in the 3 months after study entry
* Breastfeeding
* If sexually active and fertile (no tubal ligation or hysterectomy), refusal to use two forms of birth control (e.g., condom and hormonal birth control) during the 60-day study
* Estimated glomerular filtration rate (GFR) less than 60 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) method
* Albuminuria (greater than 30 mg urine albumin per g of urine creatinine)
* Blood donation within 56 days of the screening visit
* Any grade I or higher abnormality in hemoglobin, platelets, serum phosphorous, and lipase on the screening visit; grade I abnormalities in other labs will be evaluated on a case by case basis (using DAIDS criteria)
* Any greater than grade I abnormality in screening laboratory tests (using DAIDS grading criteria)
* Medical history of chronic uncontrolled high blood pressure equal to or above 140/90 mm Hg
* Use of any investigational medication in the 30 days before study entry
* Daily anticoagulant therapy (daily aspirin or non-steroidal anti-inflammatory drugs \[NSAIDs\] will be allowed if discontinued for 1 week prior to the rectal biopsy)
* Any nephrotoxic concomitant medication (e.g., aminoglycosides, cyclosporine, cidofovir, foscarnet, amphotericin B)
* Active recreational drug or alcohol abuse
* Any concomitant medication (or herbal product) that, in the opinion of the investigators, would interfere with the study outcomes (acceptable medications include acetaminophen, occasional ibuprofen/NSAID, vitamins, and birth control pills)
* History of pathologic bone fractures
* Any chronic or acute medical condition that, in the opinion of the investigator, would interfere with study conditions, such as cancer, heart disease, or diabetes
* Body weight under 110 pounds
* Antiretroviral therapy in the preceding 6 months
* Pregnant or planning to become pregnant in the 3 months after study entry
* Breastfeeding
* If sexually active and fertile (no tubal ligation or hysterectomy), refusal to use two forms of birth control (e.g., condom and hormonal birth control) during the 60-day study
* Estimated GFR less than 60 mL/min/1.73 m\^2 by the MDRD method
* Albuminuria (greater than 30 mg urine albumin per g of urine creatinine)
* Greater than a grade II abnormality in hemoglobin or platelets. Greater than a grade II abnormality in other clinical chemistry or hematology tests that, in the opinion of the investigators (principal investigator, study coordinator, and study physician) and primary clinician, would preclude participation in the study. DAIDS grading criteria will be used.
* Use of any investigational medication in the 30 days before study entry
* Daily anticoagulant therapy (daily aspirin or NSAIDs will be allowed if discontinued for 1 week prior to the rectal biopsy)
* Any nephrotoxic concomitant medication (e.g., aminoglycosides, cyclosporine, cidofovir, foscarnet, amphotericin B)
* Any concomitant medication (or herbal product) that, in the opinion of the investigators, would interfere with the study outcomes (acceptable medications include acetaminophen, occasional ibuprofen/NSAID, vitamins, and birth control pills)
* Any chronic or acute medical condition that, in the opinion of the investigator, could lead to emergent health complications, or could interfere with the participant's ability to follow study procedures
* Body weight under 110 pounds
18 Years
55 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Peter L. Anderson, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado CTRC CRS
Aurora, Colorado, United States
Countries
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References
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Castillo-Mancilla J, Seifert S, Campbell K, Coleman S, McAllister K, Zheng JH, Gardner EM, Liu A, Glidden DV, Grant R, Hosek S, Wilson CM, Bushman LR, MaWhinney S, Anderson PL. Emtricitabine-Triphosphate in Dried Blood Spots as a Marker of Recent Dosing. Antimicrob Agents Chemother. 2016 Oct 21;60(11):6692-6697. doi: 10.1128/AAC.01017-16. Print 2016 Nov.
Chen X, Castillo-Mancilla JR, Seifert SM, McAllister KB, Zheng JH, Bushman LR, MaWhinney S, Anderson PL. Analysis of the Endogenous Deoxynucleoside Triphosphate Pool in HIV-Positive and -Negative Individuals Receiving Tenofovir-Emtricitabine. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5387-92. doi: 10.1128/AAC.01019-16. Print 2016 Sep.
Castillo-Mancilla JR, Meditz A, Wilson C, Zheng JH, Palmer BE, Lee EJ, Gardner EM, Seifert S, Kerr B, Bushman LR, MaWhinney S, Anderson PL. Reduced immune activation during tenofovir-emtricitabine therapy in HIV-negative individuals. J Acquir Immune Defic Syndr. 2015 Apr 15;68(5):495-501. doi: 10.1097/QAI.0000000000000529.
Related Links
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Click here for the "Chemoprophylaxis for HIV Prevention in Men (iPrEx)" ClinicalTrials.gov study record.
Other Identifiers
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10817
Identifier Type: REGISTRY
Identifier Source: secondary_id
U01 Anderson
Identifier Type: -
Identifier Source: org_study_id