Trial · NCT00119106

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

NCT00119106, Phase 2, Phase 3, Completed, Centers for Disease Control and Prevention; results first posted 2021-01-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand. Trials, record NCT00119106. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00119106

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Bangkok Tenofovir Study, an HIV Pre-exposure Prophylaxis Trial, Bangkok, Thailand
NCT number: NCT00119106
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 2,413 participants, actual
Lead sponsor: Centers for Disease Control and Prevention
Conditions: HIV Infections
Interventions: Tenofovir disoproxil, Placebo
First posted: 2005-07-13
Last updated: 2021-02-10
Results first posted: 2021-01-27
Limitations and caveats: Participants could have under-reported stigmatised behaviours such as injecting drugs.30

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Rates of HIV Seroconversion	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.
Primary	Renal Toxicity	Blood tested for creatinine level at enrollment and every 3 months, up to 6.9 years	Number of Participants with Grade 3 or 4 Renal Laboratory Toxicities
Primary	Adverse Events	Up to 6.9 years	Number of Participants with adverse clinical events in tenofovir and placebo arms
Secondary	Number of Participants Reporting Injecting and Sharing Needles	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.
Secondary	Adherence to Study Drug/Placebo	Participants were asked about adherence at 3 month visits, up to 6.9 years.	Mean number of days that participants took study drug based on study drug diaries by study group.
Secondary	HIV Viral Load Copies/mL Measured at First Positive HIV Test Result by Group	Among people who seroconverted, viral load was measured at month 1, 2, and every 4 months after HIV seroconversion	Plasma HIV RNA concentrations.
Secondary	Number Participants Who Reported More Than One Sexual Partner at Baseline	At enrolment	Number of participants
Secondary	Number of Participants With Tenofovir-associated Resistance Mutations.	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rates of HIV Seroconversion	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		Infections/ 100 person-years	NUMBER
PRIMARY	Renal Toxicity	Blood tested for creatinine level at enrollment and every 3 months, up to 6.9 years	creatinine clearance measured in all participants every 3 months	participants	NUMBER
PRIMARY	Adverse Events	Up to 6.9 years		participants	NUMBER
SECONDARY	Number of Participants Reporting Injecting and Sharing Needles	Participants were asked about injecting and needle sharing behaviors at enrollment and every 3 month visit, up to 6.9 years		participants	NUMBER
SECONDARY	Adherence to Study Drug/Placebo	Participants were asked about adherence at 3 month visits, up to 6.9 years.	All participants	days	MEAN
SECONDARY	HIV Viral Load Copies/mL Measured at First Positive HIV Test Result by Group	Among people who seroconverted, viral load was measured at month 1, 2, and every 4 months after HIV seroconversion	Participants who seroconverted during follow-up.	Copies/mL	MEAN
SECONDARY	Number Participants Who Reported More Than One Sexual Partner at Baseline	At enrolment		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Tenofovir-associated Resistance Mutations.	Specimens collected at the time of HIV seroconversion		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Rates of HIV Seroconversion	Tenofovir	17		Infections/ 100 person-years
Rates of HIV Seroconversion	Placebo	33		Infections/ 100 person-years
Renal Toxicity	Tenofovir	3		participants
Renal Toxicity	Placebo	3		participants
Adverse Events	Tenofovir	1098		participants
Adverse Events	Placebo	1083		participants
Number of Participants Reporting Injecting and Sharing Needles	Tenofovir	58		participants
Number of Participants Reporting Injecting and Sharing Needles	Placebo	59		participants
Adherence to Study Drug/Placebo	Tenofovir	84	Standard Deviation 23	days
Adherence to Study Drug/Placebo	Placebo	84	Standard Deviation 23	days

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tenofovir	1,204
Overall Study	STARTED	Placebo	1,209
Overall Study	COMPLETED	Tenofovir	1,025
Overall Study	COMPLETED	Placebo	1,031
Overall Study	NOT COMPLETED	Tenofovir	179
Overall Study	NOT COMPLETED	Placebo	178

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	AE	Investigations	Tenofovir	1,098	1,204	10,965
other	AE	Investigations	Placebo	1,083	1,209	11,550
other	Renal toxicity	Renal and urinary disorders	Tenofovir	3	1,204	4
other	Renal toxicity	Renal and urinary disorders	Placebo	3	1,209	3
serious	Any serious adverse event	Investigations	Tenofovir	227	1,204	340
serious	Any serious adverse event	Investigations	Placebo	246	1,209	375

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tenofovir	49	1,204
Total, all-cause mortality	Placebo	58	1,209
Total, other adverse events	Tenofovir	1,098	1,204
Total, other adverse events	Placebo	1,083	1,209
Total, serious adverse events	Tenofovir	227	1,204
Total, serious adverse events	Placebo	246	1,209

Source ClinicalTrials.gov

Papers9

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21969870	DERIVED	PubMed
23769234	BACKGROUND	PubMed
24667938	BACKGROUND	PubMed
24829212	DERIVED	PubMed
25880964	BACKGROUND	PubMed
25985403	BACKGROUND	PubMed
26717405	DERIVED	PubMed
27866873	BACKGROUND	PubMed
33126825	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons7

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tenofovir vs Placebo: Number of Participants With Tenofovir-associated Resistance Mutations.	Trial comparisons
Tenofovir Group vs Placebo Group: Number Participants Who Reported More Than One Sexual Partner at Baseline	Trial comparisons
Tenofovir vs Placebo: Renal Toxicity	Trial comparisons
Tenofovir vs Placebo: Adverse Events	Trial comparisons
Tenofovir vs Placebo: Number of Participants Reporting Injecting and Sharing Needles	Trial comparisons
Tenofovir vs Placebo: deaths from any cause	Trial comparisons
Tenofovir vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00119106

GET https://conductscience.org/api/trials/v1/NCT00119106/registered

API reference For AI assistants