Trial Outcomes & Findings for Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy (NCT NCT02012621)

Results Overview

HIV viral load, binary cutoff at assay level of detection (\<20 copies/mL vs. \>= 20 copies/mL); reference group: drug concentration (TFV-DP) \< 350 femtomole (fmol)/punch vs. drug concentration (TFV-DP) \>= 1850 fmol/punch; adjusted odds ratio calculated using generalized estimating equations; concentration cutoffs established in prior research of healthy volunteers

Recruitment status

COMPLETED

Target enrollment

807 participants

Primary outcome timeframe

Up to 48 Weeks

Results posted on

2019-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Study Cohort 807 persons living with HIV (PLWH) on tenofovir disoproxil fumarate (TDF) at baseline were followed for up to three visits or 48 weeks.
Overall Study STARTED	807
Overall Study Visit 1 Completed	807
Overall Study Visit 2 Completed	688
Overall Study Visit 3 Completed	444
Overall Study COMPLETED	807
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quantifying Drug Adherence and Drug Exposure to Antiretroviral Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Cohort n=807 Participants 807 persons living with HIV (PLWH) on tenofovir disoproxil fumarate (TDF) at baseline were followed for up to three visits or 48 weeks.
Age, Continuous	46 years n=93 Participants
Sex: Female, Male Female	126 Participants n=93 Participants
Sex: Female, Male Male	681 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	149 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	472 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	147 Participants n=93 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	39 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 48 Weeks

Population: Drug concentrations were available from 532 participants

HIV viral load, binary cutoff at assay level of detection (\<20 copies/mL vs. \>= 20 copies/mL); reference group: drug concentration (TFV-DP) \< 350 femtomole (fmol)/punch vs. drug concentration (TFV-DP) \>= 1850 fmol/punch; adjusted odds ratio calculated using generalized estimating equations; concentration cutoffs established in prior research of healthy volunteers

Outcome measures

Outcome measures
Measure	Study Cohort n=532 Participants 807 persons living with HIV (PLWH) on tenofovir disoproxil fumarate (TDF) at baseline were followed for up to three visits or 48 weeks.
Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated With Odds of HIV Viral Suppression at All Study Visits	73.5 Adjusted odds ratio (aOR) Interval 25.7 to 210.5

PRIMARY outcome

Timeframe: Up to 48 Weeks

Population: Three-month self-reported adherence data were available from 482 participants

HIV viral load, binary cutoff at assay level of detection (\<20 copies/mL vs. \>= 20 copies/mL); reference group: three-month self-reported adherence \<28.5% vs. three-month self-reported adherence 100%; adherence cutoffs established in prior research

Outcome measures

Outcome measures
Measure	Study Cohort n=482 Participants 807 persons living with HIV (PLWH) on tenofovir disoproxil fumarate (TDF) at baseline were followed for up to three visits or 48 weeks.
Adjusted Odds Ratio of Three-month Self-reported Adeherence Associated With Odds of HIV Viral Suppression at All Study Visits	8.5 Adjusted odds ratio (aOR) Interval 2.3 to 30.9

PRIMARY outcome

Timeframe: Up to 48 Weeks

Population: Paired drug concentration (TFV-DP) and HIV VL assessments were available from 451 participants

HIV viral load, binary cutoff at assay level of detection (\<20 copies/mL vs. \>= 20 copies/mL); drug concentration (TFV-DP) \<800 femtomole (fmol)/punch) vs reference group of drug concentration (TFV-DP) \>= 1650 fmol/punch; adjusted odds ratio calculated using generalized estimating equations

Outcome measures

Outcome measures
Measure	Study Cohort n=451 Participants 807 persons living with HIV (PLWH) on tenofovir disoproxil fumarate (TDF) at baseline were followed for up to three visits or 48 weeks.
Adjusted Odds Ratio of Level of Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) Associated With Odds of HIV Viral Suppression at Next Study Visit	4.7 Adjusted odds ratio (aOR) Interval 2.6 to 8.7

Adverse Events

Study Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jose Castillo-Mancilla

University of Colorado-AMC

Phone: 303-724-4934

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place