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Ensayos clínicos

Ensayos clínicos

Evaluation of the Cellular Pharmacology of Tenofovir and Emtricitabine According to HIV Infection Status

Patrocinador(es) del estudio: National Institute of Allergy and Infectious Diseases (NIAID)
Números de identificación: NCT01040091, U01 Anderson
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Propósito del estudio

Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are two antiretroviral medications used for the treatment and prevention of HIV/AIDS. This study will examine how these medications are processed in the body of people who are HIV-infected, as well as in people who are HIV-uninfected.

Afección:Fase:
Infecciones por el VIH
Fase 1/Fase 2

Detalles del estudio

Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are both nucleoside reverse

transcriptase inhibitors (NRTIs), a class of medications used for the treatment and

prevention of HIV/AIDS. Analyzing how the body interacts with these medications at the

cellular level may lead to more effective dosing strategies for both HIV prevention and

treatment. This study will examine the pharmacokinetics of TDF and FTC at the cellular level

in HIV-infected people who have not previously received antiretroviral medications (N=20)

and HIV-uninfected people (N=20). HIV-infected participants will be allowed to take part in

this study only if their doctor already plans to prescribe TDF, FTC, and efavirenz (EFV) for

their HIV care, regardless of their participation in this study. HIV-uninfected volunteers

will receive 30 days of TDF/FTC. HIV-infected participants will remain on their therapy

throughout the study as part of their HIV care. The study duration is 60 days. At a baseline

study visit and most other study visits, all participants will undergo blood and urine

collection for pharmacology studies, a medication history review, and an adverse effects

questionnaire. 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. 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. 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).Tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) are both nucleoside reverse

transcriptase inhibitors (NRTIs), a class of medications used for the treatment and

prevention of HIV/AIDS. Analyzing how the body interacts with these medications at the

cellular level may lead to more effective dosing strategies for both HIV prevention and

treatment. This study will examine the pharmacokinetics of TDF and FTC at the cellular level

in HIV-infected people who have not previously received antiretroviral medications (N=20)

and HIV-uninfected people (N=20). HIV-infected participants will be allowed to take part in

this study only if their doctor already plans to prescribe TDF, FTC, and efavirenz (EFV) for

their HIV care, regardless of their participation in this study. HIV-uninfected volunteers

will receive 30 days of TDF/FTC. HIV-infected participants will remain on their therapy

throughout the study as part of their HIV care. The study duration is 60 days. At a baseline

study visit and most other study visits, all participants will undergo blood and urine

collection for pharmacology studies, a medication history review, and an adverse effects

questionnaire. 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. 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. 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).

Criterios de inclusión

    for HIV-Uninfected Participants:
    • Ability to provide informed consent
    • Ability to comply with the study procedures

Criterios de exclusión

    for HIV-Uninfected Participants:
    • Positive screening test for HIV infection
    • 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 m2 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
    • Certain abnormal laboratory values (using DAIDS grading criteria). See protocol for
    more information.
    • 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
    Inclusion Criteria for HIV-Infected Participants:
    • 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

Centros de estudio/contactos

Colorado

    University of Colorado CTRC CRS, Aurora, Colorado, 80045, United States

Actualizado: 9 de febrero del 2010

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