A Phase 4 interventional study of emtricitabine 200mg/tenofovir 300mg in HIV Prevention, sponsored by University of California, Los Angeles. Completed at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-06.
Sponsored by University of California, Los Angeles · Phase 4, Interventional, and Prevention
The purpose of this study is to evaluate the safety, acceptability and feasibility of delivery of Pre-Exposure Prophylaxis (PrEP) or Post-Exposure Prophylaxis) PEP as part of combination HIV prevention services for high-risk MSM and transgender women.
Two community-based sites (LALGBT Center and The OASIS Clinic) will serve as facilities at which participants may present for screening for prevention services. At the sites, eligibility criteria will be assessed, HIV, Sexually Transmitted Disease (STD) and laboratory testing will be performed, and HIV prevention service referrals will be initiated. Follow-up will be on a monthly basis for the first three months, and then de-escalated to an every-3-month interval.
The program stratifies participants into two cohorts on the basis of sexual risk behavior: a low-moderate risk cohort (LM) and a high-risk cohort (H). Participants in the LM cohort will be provided a customized prevention package (CPP) including access to PEP for emergency HIV prevention in the event of unanticipated HIV exposure. Participants in the H cohort will be provided a CPP including daily Truvada-based PrEP. All participants will be followed for 48 weeks. Participants in the LM cohort who, on longitudinal sexual risk behavior surveillance, report increased levels of sexual risk-taking such that they meet enrollment criteria for the H-cohort will be transitioned to the H-cohort.
At each follow-up visit, a careful safety assessment will be made, including signs/symptoms and laboratory assessments. STD testing will be performed at 3 month intervals. An escalating-intensity adherence intervention will be implemented based on real-time plasma tenofovir levels. A computer-assisted self-interview (CASI) will be used to capture detailed sexual risk, adherence, and substance use behavior.
University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the H cohort will be provided with a CPP, including daily oral emtricitabine/tenofovir-based PrEP. High Risk Cohort Criteria (one or more of the following has to be met): 1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months. 2. STD diagnosis during the last 12 months. 3. Previous PEP use during the last 12 months (\* see exclusion criteria) 4. Has at least one HIV infected sexual partner for ≥4 weeks.
Drug: emtricitabine 200mg/tenofovir 300mg
Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.
Drug: emtricitabine 200mg/tenofovir 300mg
The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in creatinine clearance (CrCl) to \<50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with CrCl \<30 mL/min, Truvada will be discontinued.
Also known as: Truvada
Number of Participants With a Grade 2 or Higher Adverse Event by Cohort
Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort.
Time frame: Baseline to 48 weeks
Cohort H PrEP Engagement by Study Visit
Optimal adherence to daily oral emtricitabine/tenofovir disoproxil fumarate by study visit as measured by tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Optimal adherence is defined as TFV-DP levels great than or equal to 700 femtomoles per punch in DBS samples (approximately 4 or more doses a week over the past 60 days).
Time frame: Baseline to 48 weeks
Escalation in Transmission Risk Behavior Among Participants Reporting Low Risk Behaviors at Baseline
Changes in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time.
Time frame: Baseline to 48 weeks
Number of HIV Seroconversions by Cohort.
Time frame: Baseline to 48 weeks
| Milestone | Cohort H (PrEP) | Cohort LM (PEP) |
|---|---|---|
| Started | 297 | 4 |
| Week 0 | 297 | 4 |
| Week 4 | 284 | 4 |
| Week 8 | 278 | 4 |
| Week 12 | 272 | 2 |
| Week 24 | 260 | 1 |
| Week 36 | 247 | 1 |
| Week 48 | 222 | 1 |
| Completed | 218 | 1 |
| Not completed | 79 | 3 |
Number and frequency rate of clinical and laboratory AEs (Gr 2 and above), including SAEs by Cohort.
| Participants | Cohort H (PrEP) | Cohort LM (PEP) |
|---|---|---|
| Number of Participants With a Grade 2 or Higher Adverse Event by Cohort | 230 | 0 |
Optimal adherence to daily oral emtricitabine/tenofovir disoproxil fumarate by study visit as measured by tenofovir diphosphate (TFV-DP) in dried blood spots (DBS). Optimal adherence is defined as TFV-DP levels great than or equal to 700 femtomoles per punch in DBS samples (approximately 4 or more doses a week over the past 60 days).
| Participants | Cohort H (PrEP) |
|---|---|
| Week 4 | 246 |
| Week 12 | 247 |
| Week 24 | 224 |
| Week 36 | 212 |
| Week 48 | 194 |
Changes in sexual risk behavior as assessed via CASI-based self-report questionnaire, measured longitudinally over time.
| Participants | Cohort H (PrEP) and Cohort LM (PEP) |
|---|---|
| High risk reported at baseline and remained high | 278 |
| Risk increased from low (baseline) to high | 19 |
| Low risk reported at baseline and remained low | 4 |
| Participants | Cohort H (PrEP) | Cohort LM (PEP) |
|---|---|---|
| Number of HIV Seroconversions by Cohort. | 1 | 0 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort H (PrEP) | — | 2/297 (0.7%) | 195/297 (65.7%) |
| Cohort LM (PEP) | — | 0/4 (0%) | 0/4 (0%) |
| Event | Cohort H (PrEP) | Cohort LM (PEP) |
|---|---|---|
| Suicidal IdeationPsychiatric disorders | 1/297 | 0/4 |
| AngerPsychiatric disorders | 1/297 | 0/4 |
| Intentional self-injuryPsychiatric disorders | 1/297 | 0/4 |
| Event | Cohort H (PrEP) | Cohort LM (PEP) |
|---|---|---|
| Proctitis chlamydialInfections and infestations | 84/297 | 0/4 |
| Oropharyngeal gonococcal infectionInfections and infestations | 65/297 | 0/4 |
| HypophosphataemiaMetabolism and nutrition disorders | 62/297 | 0/4 |
| Proctitis gonococcalInfections and infestations | 56/297 | 0/4 |
| SyphilisInfections and infestations | 33/297 | 0/4 |
| Urethritis chlamydialInfections and infestations | 23/297 | 0/4 |
| Alanine aminotransferase increasedInvestigations | 13/297 | 0/4 |
| Age, Continuous(years) | Cohort H (PrEP) | Cohort LM (PEP) | Total |
|---|---|---|---|
| Median | 33 (28 to 42) | 35 (32 to 39) | 34 (28 to 42) |
| Sex/Gender, Customized(Participants) | Cohort H (PrEP) | Cohort LM (PEP) | Total |
|---|---|---|---|
| Male — Male | 296 | 4 | 300 |
| Male — Transfemale | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Cohort H (PrEP) | Cohort LM (PEP) | Total |
|---|---|---|---|
| Non-Hispanic White | 150 | 1 | 151 |
| Non-Hispanic Black | 30 | 0 | 30 |
| Hispanic/Latino | 82 | 1 | 83 |
| Asian | 14 | 1 | 15 |
| Pacific Islander/Alaskan Native | 4 | 0 | 4 |
| Mixed Race/Other | 16 | 1 | 17 |
| Region of Enrollment(Participants) | Cohort H (PrEP) | Cohort LM (PEP) | Total |
|---|---|---|---|
| United States | 297 | 4 | 301 |
| Education(Participants) | Cohort H (PrEP) | Cohort LM (PEP) | Total |
|---|---|---|---|
| High school or less | 33 | 0 | 33 |
| Some college | 105 | 1 | 106 |
| College graduate | 104 | 2 | 106 |
| Any postgraduate | 55 | 1 | 56 |
| Insurance(Participants) | Cohort H (PrEP) | Cohort LM (PEP) | Total |
|---|---|---|---|
| Uninsured | 91 | 2 | 93 |
| Insured | 200 | 1 | 201 |
| Unknown | 6 | 1 | 7 |
| Marital Status(Participants) | Cohort H (PrEP) | Cohort LM (PEP) | Total |
|---|---|---|---|
| Married/civil union/legal partnership | 9 | 0 | 9 |
| Living with primary or main partner | 42 | 0 | 42 |
| Have primary or main partner, not living together | 39 | 0 | 39 |
| Single/divorced/widowed | 194 | 4 | 198 |
| Other | 12 | 0 | 12 |
| Unknown | 1 | 0 | 1 |
| Family Income(Participants) | Cohort H (PrEP) | Cohort LM (PEP) | Total |
|---|---|---|---|
| $20,000 or less | 92 | 0 | 92 |
| $20,001 - $50,000 | 111 | 3 | 114 |
| $50,001 or more | 94 | 1 | 95 |
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles