HIV InfectionsPhase 1NCT02985996
Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities
A Phase 1 study testing Truvada and Genvoya in people with HIV Infections, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women. These new agents might be considered for pre-exposure prophylaxis regimens in the future. Read more about this study
- Who is it for?
- Ages 18 to 49 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Truvada and Genvoya
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2017to 29 Nov 2017
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 49 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- HIV-negative man who reports receptive anal sex with another man in the last 6 months
- Male to female transgender women who have sex with men who report receptive anal intercourse with another man in the last 6 months and are not currently taking hormonal therapy or plan to take hormonal therapy for the duration of the study
- Not currently taking PrEP and no plans to initiate during study
- Able to provide informed consent in English
- No plans for relocation in the next 3 months
- Willing to undergo peripheral blood and rectal biopsy sampling
- Willing to use study products as directed
- Willing to abstain from receptive anal intercourse 3 days prior to starting study product and for the duration of the study and for 7 days after any rectal biopsy procedure.
Who cannot join
- History of inflammatory bowel disease or other inflammatory, infiltrative, infectious or vascular condition involving the lower gastrointestinal tract that, in the judgment of the investigators, may be worsened by study procedures or may significantly distort the anatomy of the distal large bowel
- Significant laboratory abnormalities at baseline visit, including but not limited to:
- Hgb ≤ 10 g/dL
- PTT > 1.5x ULN or INR > 1.5x ULN
- Platelet count <100,000
- Creatinine clearance <60
Show all 24Show fewer
- Any known medical condition that, in the judgment of the investigators, increases the risk of local or systemic complications of endoscopic procedures or pelvic examination, including but not limited to:
- Uncontrolled or severe cardiac arrhythmia
- Recent major abdominal, cardiothoracic, or neurological surgery
- History of uncontrolled bleeding diathesis
- History of colonic, rectal, or vaginal perforation, fistula, or malignancy
- History or evidence on clinical examination of ulcerative, suppurative, or proliferative lesions of the anorectal or vaginal mucosa, or untreated sexually transmitted disease with mucosal involvement
- Continued need for, or use during the 14 days prior to enrollment, of the following medications:
- Aspirin or more than 4 doses of NSAIDs
- Warfarin, heparin (low-molecular weight or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents
- Any form of rectally administered agent besides products lubricants or douching used for sexual intercourse
- Continued need for, or use during the 90 days prior to enrollment, of the following medications:
- Systemic immunomodulatory agents
- Supraphysiologic doses of steroids
- Experimental medications, vaccines, or biologicals
- Intent to use HIV antiretroviral pre-exposure prophylaxis (PrEP) during the study, outside of the study procedures
- Symptoms of an untreated rectal sexually transmitted infection (e.g. rectal pain, discharge, bleeding, etc.)
- Current use of hormonal therapy
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women. These new agents might be considered for pre-exposure prophylaxis regimens in the future. This study will include 90 healthy, HIV-negative men who have sex with men and transgender women who are not taking hormones aged 18-49 years. Participant must be willing to participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.
Read the detailed description
Men who have sex with men (MSM) and Transgender women (TGW) who have sex with men continue to be disproportionately affected by HIV. Over 60% of new HIV infections in the US occur among MSM. The majority of HIV infections among MSM and TGW occur through exposure to the rectal mucosa during receptive anal intercourse (RAI). Pre-exposure prophylaxis (PrEP) is a new HIV prevention method that is recommended by CDC and WHO for MSM at risk of HIV infection. PrEP entails taking an anti-HIV medication (Truvada®; tenofovir/emtricitabine) on a daily basis to prevent HIV infection. However, current tenofovir- based regimens have shown to have side effects that researchers are hoping to reduce in newly developed anti-HIV agents. This study is designed to examine the ability of these new agents to penetrate mucosal tissues and potentially prevent HIV infection during RAI exposure for MSM and TGW.
- Conditions
- HIV Infections
- Being tested
- Truvada, Genvoya
- Keywords
- Preventative Medicine, Infectious Diseases, Sexually Transmitted Diseases
- Medical subject headings
- HIV Infections, Communicable Diseases, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruvadaDrug
Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.
GenvoyaDrug
Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.
| Study group | Role | What they receive |
|---|---|---|
| Phase I/Pre-Drug | No intervention | Ten participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. |
| Phase II/Genvoya | Experimental | Participants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. Receives: Drug: Genvoya |
| Phase II/Truvada | Experimental | Participants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. Receives: Drug: Truvada |
| Phase III/Genvoya | Experimental | Participants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. Receives: Drug: Genvoya |
| Phase III/Truvada | Experimental | Participants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. Receives: Drug: Truvada |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Intracellular Emtricitabine Triphosphate (FTC-TP)
Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Changes in Intracellular Tenofovir Diphosphate (TFV-DP)
Intracellular tenofovir diphosphate (TFV-DP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Secondary outcomes (19)
Change in Plasma Emtricitabine (FTC) Concentration
Plasma emtricitabine (FTC) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration
Plasma tenofovir disoproxil fumarate (TDF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Plasma Tenofovir Alafenamide (TAF) Concentration
Plasma tenofovir alafenamide (TAF) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Plasma Elvitegravir (EVG) Concentration
Plasma elvitegravir (EVG) concentration is measured from blood specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Emtricitabine (FTC) Concentration
Emtricitabine (FTC) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration
Tenofovir disoproxil fumarate (TDF), concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Tenofovir Alafenamide (TAF) Concentration
Tenofovir alafenamide (TAF) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Elvitegravir (EVG) Concentration
Elvitegravir (EVG) concentration is measured from rectal secretion specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Tenofovir Alafenamide (TAF) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
Intracellular tenofovir alafenamide (TAF) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Elvitegravir (EVG) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
Intracellular elvitegravir (EVG) concentration is measured from isolated PBMCs collected via blood draw. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue
Tissue emtricitabine (FTC) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue
Intracellular tenofovir (TFV) Concentration in Rectal Tissue is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Tenofovir Alafenamide (TAF) Concentration in Rectal Tissue
Tissue tenofovir alafenamide (TAF) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Elvitegravir (EVG) Concentration in Rectal Tissue
Tissue elvitegravir (EVG) concentration is measured from rectal biopsies and isolated cells. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Emtricitabine (FTC) Concentration in Penile Secretions
Emtricitabine (FTC) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions
Tenofovir disoproxil fumarate (TDF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Tenofovir Alafenamide (TAF) Concentration in Penile Secretions
Tenofovir alafenamide (TAF) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
Change in Elvitegravir (EVG) Concentration in Penile Secretions
Elvitegravir (EVG) concentrations is measured from urethral and penile specimen. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Baseline, Visit 4 (Up to ten days post drug)
PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV
Rectal biopsies will be subjected to in vitro infection with HIV to test for changes in susceptibility to virus infection. Concentrations of cumulative p24 production in supernatants following in vitro infection of rectal biopsies correlate with viral infection and replication in rectal biopsies. Therefore, lower concentrations of p24 production in biopsies collected from men receiving PrEP compared to controls indicates a potential greater protection from infection and potential increased PrEP efficacy.
For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Measured: Up to 10 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start6 Feb 2017
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Colleen Kelley, Emory University
- Investigators
- Colleen Kelley, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985996
- Sponsor's protocol ID
- IRB00092488
- Status last verified
- Aug 2019
- First submitted
- 5 Dec 2016
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Compartment PK for New HIV Pre-exposure Prophylaxis Modalities
- ClinicalTrials.gov ID
- NCT02985996
- Acronym / sponsor ID
- IRB00092488
- Conditions
- HIV Infections
- Keywords
- Preventative Medicine, Infectious Diseases, Sexually Transmitted Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Posted 17 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the ability of new anti-HIV agents to penetrate different body compartments in HIV negative men who have sex with men and transgender women. These new agents might be considered for pre-exposure prophylaxis regimens in the future. This study will include 90 healthy, HIV-negative men who have sex with men and transgender women who are not taking hormones aged 18-49 years. Participant must be willing to participate in 1 of the 3 study phases, be willing to take Truvada® (PrEP) or Genvoya®, and willing to undergo blood draws, urethral swabs, and rectal biopsy procedures.
Detailed description
Men who have sex with men (MSM) and Transgender women (TGW) who have sex with men continue to be disproportionately affected by HIV. Over 60% of new HIV infections in the US occur among MSM. The majority of HIV infections among MSM and TGW occur through exposure to the rectal mucosa during receptive anal intercourse (RAI). Pre-exposure prophylaxis (PrEP) is a new HIV prevention method that is recommended by CDC and WHO for MSM at risk of HIV infection. PrEP entails taking an anti-HIV medication (Truvada®; tenofovir/emtricitabine) on a daily basis to prevent HIV infection. However, current tenofovir- based regimens have shown to have side effects that researchers are hoping to reduce in newly developed anti-HIV agents. This study is designed to examine the ability of these new agents to penetrate mucosal tissues and potentially prevent HIV infection during RAI exposure for MSM and TGW.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase I/Pre-Drug | No intervention | –Ten participants will be asked to complete study phase 1. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. |
| Phase II/Genvoya | Experimental | Drug: GenvoyaParticipants will receive one dose Genvoya. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. |
| Phase II/Truvada | Experimental | Drug: TruvadaParticipants will receive one dose of Truvada. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. |
| Phase III/Genvoya | Experimental | Drug: GenvoyaParticipants will receive Genvoya once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. |
| Phase III/Truvada | Experimental | Drug: TruvadaParticipants will receive Truvada once daily for ten days. Participants will be asked to provide blood and urine samples and undergo penile, urethral, and rectal swabs. Up to 12 rectal biopsies will be taken. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- HIV-negative man who reports receptive anal sex with another man in the last 6 months
- Male to female transgender women who have sex with men who report receptive anal intercourse with another man in the last 6 months and are not currently taking hormonal therapy or plan to take hormonal therapy for the duration of the study
- Not currently taking PrEP and no plans to initiate during study
- Able to provide informed consent in English
- No plans for relocation in the next 3 months
Key exclusion criteria (24 listed)
- History of inflammatory bowel disease or other inflammatory, infiltrative, infectious or vascular condition involving the lower gastrointestinal tract that, in the judgment of the investigators, may be worsened by study procedures or may significantly distort the anatomy of the distal large bowel
- Significant laboratory abnormalities at baseline visit, including but not limited to:
- Any known medical condition that, in the judgment of the investigators, increases the risk of local or systemic complications of endoscopic procedures or pelvic examination, including but not limited to:
- Continued need for, or use during the 14 days prior to enrollment, of the following medications:
- Continued need for, or use during the 90 days prior to enrollment, of the following medications:
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 |
|---|---|---|
| TruvadaTruvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet. | Drug | Phase II/Truvada, Phase III/Truvada |
| GenvoyaGenvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet. | Drug | Phase II/Genvoya, Phase III/Genvoya |
Primary outcome
Changes in Intracellular Emtricitabine Triphosphate (FTC-TP)
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Intracellular emtricitabine triphosphate (FTC-TP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
Changes in Intracellular Tenofovir Diphosphate (TFV-DP)
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Intracellular tenofovir diphosphate (TFV-DP) is measured and compared from blood specimen in both arms from baseline to visit 4. For the pharmacokinetic analysis, values reported as "Below the Limit of Quantification" (BLOQ) are assigned a value of zero if it occurs in a profile after dosing at time zero and before the first measurable concentration.
19 secondary outcomes
Change in Plasma Emtricitabine (FTC) Concentration
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Plasma Tenofovir Disoproxil Fumarate (TDF) Concentration
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Plasma Tenofovir Alafenamide (TAF) Concentration
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Plasma Elvitegravir (EVG) Concentration
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Emtricitabine (FTC) Concentration
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Tenofovir Disoproxil Fumarate (TDF) Concentration
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Tenofovir Alafenamide (TAF) Concentration
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Rectal Elvitegravir (EVG) Concentration
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Tenofovir Alafenamide (TAF) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Elvitegravir (EVG) Concentration in Peripheral Blood Mononuclear Cells (PBMCs)
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Emtricitabine (FTC) Concentration in Rectal Tissue
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Intracellular Tenofovir (TFV) Concentration in Rectal Tissue
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Tenofovir Alafenamide (TAF) Concentration in Rectal Tissue
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Elvitegravir (EVG) Concentration in Rectal Tissue
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Emtricitabine (FTC) Concentration in Penile Secretions
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Tenofovir Disoproxil Fumarate (TDF) Concentration in Penile Secretions
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Tenofovir Alafenamide (TAF) Concentration in Penile Secretions
Time frame: Baseline, Visit 4 (Up to ten days post drug)
Change in Elvitegravir (EVG) Concentration in Penile Secretions
Time frame: Baseline, Visit 4 (Up to ten days post drug)
PrEP Efficacy as Measured by Inhibition of in Vitro Infection of Rectal Biopsies to HIV
Time frame: Up to 10 months post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Colleen Kelley, MD, MPH principal investigator
Emory University
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 Truvada and Genvoya in people with HIV Infections, run by Emory University 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 8 inclusion and 24 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 17 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 17 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Intracellular Emtricitabine Triphosphate (FTC-TP) (time frame: Baseline, Visit 4 (Up to ten days post drug)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.