Trial Outcomes & Findings for Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand (NCT NCT00119106)

NCT ID: NCT00119106

Last Updated: 2021-02-10

Results Overview

Kaplan Meier survival curve.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 2413 participants
• Primary outcome timeframe: From date of randomization until the date of first documented seroconversion or date of death from any cause, whichever came first, assessed for an average of 4.0 years, with a maximum duration of 6.9 years
• Results posted on: 2021-02-10

Participant Flow

Participant milestones

Measure	Tenofovir Tenofovir Tenofovir	Placebo Placebo Tenofovir
Overall Study STARTED	1204	1209
Overall Study COMPLETED	1025	1031
Overall Study NOT COMPLETED	179	178

Reasons for withdrawal

Measure	Tenofovir Tenofovir Tenofovir	Placebo Placebo Tenofovir
Overall Study HIV infected at baseline	179	178

Baseline Characteristics

Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand

Baseline characteristics by cohort

Measure	Tenofovir n=1204 Participants Tenofovir Tenofovir	Placebo n=1207 Participants Placebo Tenofovir	Total n=2411 Participants Total of all reporting groups
Age, Continuous	31 years STANDARD_DEVIATION 8 • n=5 Participants	31 years STANDARD_DEVIATION 8 • n=7 Participants	31 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	246 Participants n=5 Participants	241 Participants n=7 Participants	487 Participants n=5 Participants
Sex: Female, Male Male	958 Participants n=5 Participants	966 Participants n=7 Participants	1924 Participants n=5 Participants
Region of Enrollment Thailand	1204 participants n=5 Participants	1207 participants n=7 Participants	2411 participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of first documented seroconversion or date of death from any cause, whichever came first, assessed for an average of 4.0 years, with a maximum duration of 6.9 years

Kaplan Meier survival curve.

Outcome measures

Measure	Tenofovir n=1204 Participants	Placebo n=1209 Participants
Rates of HIV Seroconversion	17 Infections/ 100 person-years	33 Infections/ 100 person-years

PRIMARY outcome

Timeframe: Blood tested for creatinine level at enrollment and every 3 months, up to 6.9 years

Population: creatinine clearance measured in all participants every 3 months

Number of Participants with Grade 3 or 4 Renal Laboratory Toxicities

Outcome measures

Measure	Tenofovir n=1204 Participants	Placebo n=1209 Participants
Renal Toxicity	3 participants	3 participants

PRIMARY outcome

Timeframe: Up to 6.9 years

Number of Participants with adverse clinical events in tenofovir and placebo arms

Outcome measures

Measure	Tenofovir n=1204 Participants	Placebo n=1209 Participants
Adverse Events	1098 participants	1083 participants

SECONDARY outcome

Timeframe: Participants were asked about injecting and needle sharing behaviors at enrollment and every 3 month visit, up to 6.9 years

Number of Participants reporting injecting and sharing needles:

Assessed injecting and sharing at baseline and every 3 months during follow-up. We used GEE to determine if there was a significant decline in injecting and sharing.

Outcome measures

Measure	Tenofovir n=1204 Participants	Placebo n=1207 Participants
Number of Participants Reporting Injecting and Sharing Needles	58 participants	59 participants

SECONDARY outcome

Timeframe: Participants were asked about adherence at 3 month visits, up to 6.9 years.

Population: All participants

Mean number of days that participants took study drug based on study drug diaries by study group.

Outcome measures

Measure	Tenofovir n=1204 Participants	Placebo n=1207 Participants
Adherence to Study Drug/Placebo	84 days Standard Deviation 23	84 days Standard Deviation 23

SECONDARY outcome

Timeframe: Among people who seroconverted, viral load was measured at month 1, 2, and every 4 months after HIV seroconversion

Population: Participants who seroconverted during follow-up.

Plasma HIV RNA concentrations.

Outcome measures

Measure	Tenofovir n=33 Participants	Placebo n=17 Participants
HIV Viral Load Copies/mL Measured at First Positive HIV Test Result by Group	929829 Copies/mL Standard Deviation 2272690	120061 Copies/mL Standard Deviation 222612

SECONDARY outcome

Timeframe: At enrolment

Number of participants

Outcome measures

Measure	Tenofovir n=1204 Participants	Placebo n=1209 Participants
Number Participants Who Reported More Than One Sexual Partner at Baseline	251 Participants	271 Participants

SECONDARY outcome

Timeframe: Specimens collected at the time of HIV seroconversion

Measure tenofovir associated resistance mutations (ie, K65R and K70E) in amplified viral RNA specimens from HIV-positive participants in the placebo and tenofovir groups.

Outcome measures

Measure	Tenofovir n=14 Participants	Placebo n=29 Participants
Number of Participants With Tenofovir-associated Resistance Mutations.	0 Participants	0 Participants

Adverse Events

Tenofovir

Serious events: 227 serious events

Other events: 1098 other events

Deaths: 49 deaths

Placebo

Serious events: 246 serious events

Other events: 1083 other events

Deaths: 58 deaths

Serious adverse events

Measure	Tenofovir n=1204 participants at risk Tenofovir Tenofovir	Placebo n=1209 participants at risk Placebo Tenofovir
Investigations Any serious adverse event	18.9% 227/1204 • Number of events 340 • Participants were assessed for adverse events from the date the participant enrolled and started study drug until the participant completed follow-up, a maximum of 6.9 years.	20.3% 246/1209 • Number of events 375 • Participants were assessed for adverse events from the date the participant enrolled and started study drug until the participant completed follow-up, a maximum of 6.9 years.

Other adverse events

Measure	Tenofovir n=1204 participants at risk Tenofovir Tenofovir	Placebo n=1209 participants at risk Placebo Tenofovir
Investigations AE	91.2% 1098/1204 • Number of events 10965 • Participants were assessed for adverse events from the date the participant enrolled and started study drug until the participant completed follow-up, a maximum of 6.9 years.	89.6% 1083/1209 • Number of events 11550 • Participants were assessed for adverse events from the date the participant enrolled and started study drug until the participant completed follow-up, a maximum of 6.9 years.
Renal and urinary disorders Renal toxicity	0.25% 3/1204 • Number of events 4 • Participants were assessed for adverse events from the date the participant enrolled and started study drug until the participant completed follow-up, a maximum of 6.9 years.	0.25% 3/1209 • Number of events 3 • Participants were assessed for adverse events from the date the participant enrolled and started study drug until the participant completed follow-up, a maximum of 6.9 years.

Additional Information

Dr. Michael Martin

CDC

Phone: 662 580 0669

Email: ZND9@CDC.GOV

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place