HIV InfectionsPhase 1NCT01040091
Evaluation of the Cellular Pharmacology of Tenofovir and Emtricitabine According to HIV Infection Status
A Phase 1 study testing Emtricitabine (FTC), Tenofovir disoproxil fumarate (TDF) and Efavirenz (EFV) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Emtricitabine (FTC), Tenofovir disoproxil fumarate (TDF) and Efavirenz (EFV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to provide informed consent
- 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
Who cannot join
- 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 m^2 by the Modification of Diet in Renal Disease (MDRD) method
Show all 32Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado CTRC CRS
Aurora, Colorado, 80045
About this study
Official title: Cellular Pharmacology of Tenofovir and Emtricitabine for HIV Prophylaxis (Cell Prep)
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.
Read the detailed description
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 (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-infected participants will receive Truvada (TDF/FTC) and EFV for the first 30 days. After Day 30, participants will continue to receive TDF, FTC, and EFV through Day 60, under the direction of their physician. HIV-infected participants will remain on their therapy throughout the study as part of their HIV care. HIV-uninfected volunteers will receive 30 days of Truvada (TDF/FTC).
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
- HIV Infections
- Being tested
- Emtricitabine (FTC), Tenofovir disoproxil fumarate (TDF), Efavirenz (EFV), Truvada
- Keywords
- HIV Seronegativity, Treatment Experienced
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emtricitabine (FTC)Drug
200 mg once a day
Tenofovir disoproxil fumarate (TDF)Drug
300 mg once a day
Efavirenz (EFV)Drug
600 mg once a day
TruvadaDrug
200 mg emtricitabine + 300 mg TDF once a day
| Study group | Role | What they receive |
|---|---|---|
| HIV-Infected Participants | Active comparator | 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. Receives: Drug: Emtricitabine (FTC); Drug: Tenofovir disoproxil fumarate (TDF); Drug: Efavirenz (EFV); Drug: Truvada |
| HIV-Uninfected Participants | Active comparator | HIV-uninfected participants will receive Truvada (FTC/TDF) for 30 days. Receives: Drug: Truvada |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the first dose tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) area under the concentration-time curve (AUC) in HIV-uninfected adults versus HIV-infected adults
Measured: Measured at the time of the first dose
Comparison of average steady-state plasma deoxyguanosine concentrations before therapy and after 30 days of TDF/FTC therapy
Measured: Measured through Day 30
Comparison of TFV-DP and FTC-TP in HIV-seroconverters versus matched non-seroconverters from the iPrEx study
Measured: Measured throughout the 4-year study
Modeling describing intracellular pharmacokinetics of TFV-DP and FTC-TP in PBMCs so dosing strategies can be tested on the model to identify the optimal dosing that most rapidly achieves and sustains the desired prophylactic threshold for HIV prevention
Measured: Measured throughout the 4-year study
Secondary outcomes (13)
Definition of the terminal elimination phase of TFV-DP and FTC-TP in HIV-uninfected adults
Measured: Measured from Day 30 to 60
Characterization of TFV-DP and FTC-TP according to cell types: PBMCs, CD4-purified PBMCs (as well as erythrocytes-to include dried blood spot analyses, CD8 cells, B-cells, and monocytes), genital mononuclear cells, and rectal mucosal mononuclear cells
Measured: Measured through Day 30
Comparison of TFV-DP and FTC-TP between male and female participants
Measured: Measured through Day 30
Characterization of intracellular TFV, tenofovir-monophosphate (TFV-MP), emtricitabine-monophosphate (FTC-MP), and emtricitabine-diphosphate (FTC-DP)
Measured: Measured through Day 30
Evaluation of markers of cell activation (HLA-DR and CD38 expression) and the relationship to TFV-DP and FTC-TP concentrations
Measured: Measured through Day 30
Effects of TFV-DP and FTC-TP (and plasma EFV) on plasma HIV-RNA and CD4 counts in the HIV-infected participants
Measured: Measured through Day 60
Evaluation of relationships between adherence measures collected in iPrEx with TFV-DP and FTC-TP
Measured: Measured throughout the 4-year study
Comparison of TFV-DP and FTC-TP between African-American and non-African-American participants
Measured: Measured through Day 30
Evaluation of polymorphisms in MRP2 (eg, -24C>T, 1249G>A), MRP4 (eg, 1612C>T, 3463G>A, 3724G>A, 4131T>G), BCRP (eg, 421C>A, 34G>A) and other potentially important enzymes for the study drugs for relationships with pharmacokinetics and pharmacodynamics
Measured: Measured throughout the 4-year study
Comparison of Day 30 AUC and overall AUC (AUC over Day 1 to Day 30) TFV-DP and FTC-TP in HIV-uninfected versus HIV-infected participants
Measured: Measured through Day 30
HLA-DR / CD38 on T cells will be correlated with changed intracellular and extracellular purine levels in the HIV-uninfected participants to address potential immune-modulation associated with PNP inhibition
Measured: Measured throughout the 4-year study
Characterization of the ratios of TFV-DP and FTC-TP to corresponding endogenous deoxyribose nucleotides
Measured: Measured throughout the 4-year study
Comparison of TFV-DP and FTC-TP according to iPrEx study sites
Measured: Measured throughout the 4-year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter L. Anderson, PharmD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040091
- Sponsor's protocol ID
- U01 Anderson
- Other IDs
- 10817
- Status last verified
- Apr 2014
- First submitted
- 23 Dec 2009
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27572401Chen 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.
PubMed 27353267Castillo-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.
PubMed 25763783
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Pharmacology of Tenofovir and Emtricitabine for HIV Prophylaxis (Cell Prep)
- ClinicalTrials.gov ID
- NCT01040091
- Acronym / sponsor ID
- U01 Anderson
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, Treatment Experienced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Dec 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 (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-infected participants will receive Truvada (TDF/FTC) and EFV for the first 30 days. After Day 30, participants will continue to receive TDF, FTC, and EFV through Day 60, under the direction of their physician. HIV-infected participants will remain on their therapy throughout the study as part of their HIV care. HIV-uninfected volunteers will receive 30 days of Truvada (TDF/FTC).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-Infected Participants | Active comparator | Drug: Emtricitabine (FTC), Drug: Tenofovir disoproxil fumarate (TDF), Drug: Efavirenz (EFV), Drug: TruvadaHIV-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. |
| HIV-Uninfected Participants | Active comparator | Drug: TruvadaHIV-uninfected participants will receive Truvada (FTC/TDF) for 30 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to provide informed consent
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emtricitabine (FTC)200 mg once a day | Drug | HIV-Infected Participants |
| Tenofovir disoproxil fumarate (TDF)300 mg once a day | Drug | HIV-Infected Participants |
| Efavirenz (EFV)600 mg once a day | Drug | HIV-Infected Participants |
| Truvada200 mg emtricitabine + 300 mg TDF once a day | Drug | HIV-Infected Participants, HIV-Uninfected Participants |
Primary outcome
Comparison of the first dose tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) area under the concentration-time curve (AUC) in HIV-uninfected adults versus HIV-infected adults
Time frame: Measured at the time of the first dose
Comparison of average steady-state plasma deoxyguanosine concentrations before therapy and after 30 days of TDF/FTC therapy
Time frame: Measured through Day 30
Comparison of TFV-DP and FTC-TP in HIV-seroconverters versus matched non-seroconverters from the iPrEx study
Time frame: Measured throughout the 4-year study
Modeling describing intracellular pharmacokinetics of TFV-DP and FTC-TP in PBMCs so dosing strategies can be tested on the model to identify the optimal dosing that most rapidly achieves and sustains the desired prophylactic threshold for HIV prevention
Time frame: Measured throughout the 4-year study
13 secondary outcomes
Definition of the terminal elimination phase of TFV-DP and FTC-TP in HIV-uninfected adults
Time frame: Measured from Day 30 to 60
Characterization of TFV-DP and FTC-TP according to cell types: PBMCs, CD4-purified PBMCs (as well as erythrocytes-to include dried blood spot analyses, CD8 cells, B-cells, and monocytes), genital mononuclear cells, and rectal mucosal mononuclear cells
Time frame: Measured through Day 30
Comparison of TFV-DP and FTC-TP between male and female participants
Time frame: Measured through Day 30
Characterization of intracellular TFV, tenofovir-monophosphate (TFV-MP), emtricitabine-monophosphate (FTC-MP), and emtricitabine-diphosphate (FTC-DP)
Time frame: Measured through Day 30
Evaluation of markers of cell activation (HLA-DR and CD38 expression) and the relationship to TFV-DP and FTC-TP concentrations
Time frame: Measured through Day 30
Effects of TFV-DP and FTC-TP (and plasma EFV) on plasma HIV-RNA and CD4 counts in the HIV-infected participants
Time frame: Measured through Day 60
Evaluation of relationships between adherence measures collected in iPrEx with TFV-DP and FTC-TP
Time frame: Measured throughout the 4-year study
Comparison of TFV-DP and FTC-TP between African-American and non-African-American participants
Time frame: Measured through Day 30
Evaluation of polymorphisms in MRP2 (eg, -24C>T, 1249G>A), MRP4 (eg, 1612C>T, 3463G>A, 3724G>A, 4131T>G), BCRP (eg, 421C>A, 34G>A) and other potentially important enzymes for the study drugs for relationships with pharmacokinetics and pharmacodynamics
Time frame: Measured throughout the 4-year study
Comparison of Day 30 AUC and overall AUC (AUC over Day 1 to Day 30) TFV-DP and FTC-TP in HIV-uninfected versus HIV-infected participants
Time frame: Measured through Day 30
HLA-DR / CD38 on T cells will be correlated with changed intracellular and extracellular purine levels in the HIV-uninfected participants to address potential immune-modulation associated with PNP inhibition
Time frame: Measured throughout the 4-year study
Characterization of the ratios of TFV-DP and FTC-TP to corresponding endogenous deoxyribose nucleotides
Time frame: Measured throughout the 4-year study
Comparison of TFV-DP and FTC-TP according to iPrEx study sites
Time frame: Measured throughout the 4-year study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
- Derived from this study: PubMed 27572401Castillo-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.
- Derived from this study: PubMed 27353267Chen 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.
- Derived from this study: PubMed 25763783Castillo-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.
- Click here for the "Chemoprophylaxis for HIV Prevention in Men (iPrEx)" ClinicalTrials.gov study record.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter L. Anderson, PharmD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Emtricitabine (FTC), Tenofovir disoproxil fumarate (TDF) and Efavirenz (EFV) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the first dose tenofovir-diphosphate (TFV-DP) and emtricitabine-triphosphate (FTC-TP) area under the concentration-time curve (AUC) in HIV-uninfected adults versus HIV-infected adults (time frame: Measured at the time of the first dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01040091, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.