An Early Phase 1 interventional study of Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) in HIV/AIDS, Adherence, Medication and Drug Use, sponsored by Eastern Virginia Medical School. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Eastern Virginia Medical School · Early Phase 1, Interventional, and Diagnostic
Truvada®, an oral pill comprised of two anti-retroviral compounds, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), is currently the only drug combination approved for pre-exposure prophylaxis (PrEP) in women exposed to high HIV risk through vaginal acquisition. Adherence to the one pill per day regimen is crucial for its effectiveness in reducing the risk of acquiring HIV. Currently, there is no available point of care diagnostic test to quickly measure blood levels of tenofovir in the clinic. This study will determine whether a tenofovir (TFV) aptamer-based biosensor (aptasensor) can detect TFV in biological fluids from women randomized to different dosing regimens representing high and low adherence.
Project ADHERE is a pilot, prospective, randomized study which will screen approximately 20 healthy, non-pregnant, HIV negative, premenopausal women (aged 18-50) at Eastern Virginia Medical School (EVMS) who are not at risk of pregnancy and are at low risk for sexually transmitted infections (STIs) in order to have approximately 14 women complete all study visits. The women will be randomized to one of two different dosing regimens of Truvada for up to 14 days. The low adherence cohort will take a total of 3 Truvada pills per week while the high adherence cohort will be assigned to take daily dosing, 7 pills per week. At screening (visit 1), we will screen women for HIV-1 and perform STI tests and serum screening for Hepatitis B and creatinine clearance prior to commencing oral PrEP, consistent with oral PrEP initiation guidelines. After screening labs return, they will come to the clinic for visit 2 when baseline blood, urine, and vaginal fluid will be collected, randomize participants to the dosing regimen, watch the participants ingest the first dose, and then direct to them to take subsequent doses in their homes. Reminder text messages will be sent to the participants to facilitate doses being taken at the same time of day upon which they will text message the coordinator after ingesting the pill. Participants will return 24 hours, 7 days, and 14 days after visit 2 for pre-dose collection of blood, urine, and vaginal fluid samples (visits 3, 4, and 5, respectively). For all visits, participants will not to take the next prescribed dose before coming to the clinic. Once samples are collected, participants will ingest the next scheduled pill. However, for the high adherence regimen, the women will take their last dose on day 14 and then come to the clinic 24 hours later on day 15 for collection of samples. Regardless of regimen, sample collection will take place no earlier than 24 hours after last dosing to prevent white coat effects. Samples will be brought to the laboratory for processing and eventual measurement of TFV levels by the TFV aptasensor. Aliquots of plasma and urine will also be analyzed by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) so sensitivity and specificity of the aptasensor can be determined. The ability of the TFV aptasensor to distinguish levels associated with high and low adherence will also be assessed.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 14 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
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Must be protected from pregnancy by:
Exclusion Criteria:
TDF/FTC (300/200 mg), 7 pills/week. Total of 14 pills
Drug: Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)
TDF/FTC (300/2200 mg), 3 pills/week. Total of 6 pills
Drug: Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)
Women will take 1 pill orally according the dosing regimen of the arm to which they are assigned
Also known as: Truvada
Baseline TFV (Tenofovir) Levels in Plasma
TFV levels will be measured by the TFV aptasensor and compared to Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS) values
Time frame: Baseline (pre-dose)
Levels of TFV in Plasma After Different Lengths of Time Post-first Dose
TFV levels will be measured by the TFV aptasensor and compared to LC-MS/MS values
Time frame: 1 day
Levels of TFV in Plasma After Different Lengths of Time Post-first Dose
TFV levels will be measured by the TFV aptasensor and compared to LC-MS/MS values
Time frame: 7 days
Levels of TFV in Plasma After Different Lengths of Time Post-first Dose
TFV levels will be measured by the TFV aptasensor and compared to LC-MS/MS values
Time frame: 14 days
| Milestone | High Adherence | Low Adherence |
|---|---|---|
| Started | 7 | 7 |
| Completed | 7 | 7 |
| Not completed | 0 | 0 |
TFV levels will be measured by the TFV aptasensor and compared to Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS) values
No measurements were reported for this outcome.
TFV levels will be measured by the TFV aptasensor and compared to LC-MS/MS values
No measurements were reported for this outcome.
TFV levels will be measured by the TFV aptasensor and compared to LC-MS/MS values
No measurements were reported for this outcome.
TFV levels will be measured by the TFV aptasensor and compared to LC-MS/MS values
No measurements were reported for this outcome.
Collected over 4 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Adherence | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Low Adherence | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Event | High Adherence | Low Adherence |
|---|---|---|
| DiarrheaGastrointestinal disorders | 1/7 | 0/7 |
| NauseaGeneral disorders | 1/7 | 1/7 |
| upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 0/7 | 1/7 |
| increased appetiteGeneral disorders | 1/7 | 0/7 |
| headacheGeneral disorders | 1/7 | 0/7 |
| AllergiesRespiratory, thoracic and mediastinal disorders | 0/7 | 1/7 |
The participants served as their own baseline controls.
| Age, Categorical(Participants) | High Adherence | Low Adherence | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 7 | 14 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | High Adherence | Low Adherence | Total |
|---|---|---|---|
| Mean | 40.1 ± 10.6 | 37.7 ± 7.8 | 38.9 ± 9.1 |
| Sex: Female, Male(Participants) | High Adherence | Low Adherence | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | High Adherence | Low Adherence | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 6 | 7 | 13 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | High Adherence | Low Adherence | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 5 | 5 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | High Adherence | Low Adherence | Total |
|---|---|---|---|
| United States | 7 | 7 | 14 |
| Body Mass Index(kg/m^2) | High Adherence | Low Adherence | Total |
|---|---|---|---|
| Mean | 31.3 ± 7 | 32.4 ± 11.8 | 31.8 ± 9.3 |
| Creatinine Clearance(mL/min) | High Adherence | Low Adherence | Total |
|---|---|---|---|
| Mean | 157.2 ± 48.3 | 169 ± 77.9 | 163.1 ± 62.6 |
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Acquired Immunodeficiency Syndrome→
Eastern Virginia Medical School