Trial · NCT00458393

Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men

NCT00458393, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2018-01-24

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men. Trials, record NCT00458393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00458393

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Trial

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

Title: Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men
NCT number: NCT00458393
Status: Completed
Phases: Phase 3
Enrollment: 2,499 participants, actual
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions: HIV Infections
Interventions: daily TDF/FTC, Placebo
First posted: 2007-04-10
Last updated: 2021-11-02
Results first posted: 2018-01-24

Source ClinicalTrials.gov

Registered outcomes21

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

List	Outcome	Time frame	Description
Primary	HIV Seroconversion	Monthly follow-up through a median of 1.2 years	Confirmed HIV infection
Primary	Grade 1 or Higher Creatinine Toxicity	Duration of follow-up, median 1.2 years	Creatinine which reach grade 1 (mild, 1.1 to 1.3 local upper limit of normal) or higher by the US Division of AIDS grading table (version 1) or a 50% increase in creatinine from the baseline value. The DAIDS table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
Primary	Grade 3 or Higher Phosphorous Toxicity	The entire follow-up period, median 1.2 years	Grade 3 or higher phosphorous toxicity (hypophosphatemia) by the Division of AIDS Grading Table (severe, level at or below 1.9 mg/dL)
Primary	Grade 2, 3, or 4 Laboratory Adverse Events	Entire follow-up, median 1.2 years	Number of participants with at least one Grade 2, 3, or 4 laboratory adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
Primary	Grade 2, 3, or 4 Clinical Adverse Events	Entire follow-up, median 1.2 years	Number of participants with at least 1 Grade 2, 3, or 4 clinical adverse events (moderate, severe of life threatening based one the US Division of AIDS Grading of adverse events, version 1.0). The table can be found at https://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
Secondary	Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis	Quarterly lab tests through a median follow-up of 1.2 years	A hepatic flare is defined as an increase in alanine transaminase or aspartate transaminase to \>5 fold upper limit of normal at any visit, or an increase to \>2.5 fold upper limit of normal for 3 months, within 24 weeks of permanently stopping study drug. More details in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4752387/
Secondary	Percentage Change in Bone Mineral Density	baseline and week 24.	% Change from baseline in bone mineral density (100 \* \[(value at 24 weeks- value at baseline)/ (value at baseline)\]) in in hip and L1-L4 spine by dual-energy x-ray absorptiometry
Secondary	Percentage Change in Body Fat	Baseline and Week 24	Percentage Change (100 \* \[(value at 24 weeks- value at baseline)/ (value at baseline)\]) in Body Fat from Baseline by dual-energy x-ray absorptiometry
Secondary	Percentage Change in Fasting Triglycerides	Baseline and Week 24	Percentage Change (Percentage Change (100 \* \[(value at 24 weeks- value at baseline)/ (value at baseline)\]) in Triglycerides from Baseline from a fasting sample.
Secondary	Percent Change in Total Cholesterol	Baseline and Week 24	Percent change (100 \* \[(value at 24 weeks- value at baseline)/ (value at baseline)\]) in fasting total cholesterol from baseline

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	HIV Seroconversion	Monthly follow-up through a median of 1.2 years	Excludes participants who were HIV+ at enrollment (2 TDF/FTC, 8 Placebo) and those with no follow-up HIV test (25 TDF/FTC and 22 Placebo).	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Grade 1 or Higher Creatinine Toxicity	Duration of follow-up, median 1.2 years	All randomized participants which at least 1 follow-up creatinine value	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Grade 3 or Higher Phosphorous Toxicity	The entire follow-up period, median 1.2 years	All participants with at least 1 follow-up phosphorus value	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Grade 2, 3, or 4 Laboratory Adverse Events	Entire follow-up, median 1.2 years	At participants with at least one visit with laboratory values post-baseline	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Grade 2, 3, or 4 Clinical Adverse Events	Entire follow-up, median 1.2 years	At participants with at least one follow-up visit	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis	Quarterly lab tests through a median follow-up of 1.2 years	Those with chronic active hepatitis B at enrollment.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Percentage Change in Bone Mineral Density	baseline and week 24.	Participants confirmed to be HIV negative at enrollment who consented to participate in the metabolic substudy. Full details in https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/25908682/	percent change from baseline	MEAN
SECONDARY	Percentage Change in Body Fat	Baseline and Week 24	All participants in the body composition substudy who made a week 24 body scan	percent change from baseline	MEDIAN
SECONDARY	Percentage Change in Fasting Triglycerides	Baseline and Week 24	All participants in the metabolic substudy with a week 24 fast triglyceride value	percent change from baseline	MEDIAN
SECONDARY	Percent Change in Total Cholesterol	Baseline and Week 24	All participants in the metabolic substudy with a week 24 fasting cholesterol	percent change from baseline	MEDIAN

1 to 10 of 21Source ClinicalTrials.gov

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Results by group46

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

Outcome	Group	Value	Units
HIV Seroconversion	TDF/FTC	48	Participants
HIV Seroconversion	Placebo	83	Participants
Grade 1 or Higher Creatinine Toxicity	TDF/FTC	32	Participants
Grade 1 or Higher Creatinine Toxicity	Placebo	24	Participants
Grade 3 or Higher Phosphorous Toxicity	TDF/FTC	13	Participants
Grade 3 or Higher Phosphorous Toxicity	Placebo	10	Participants
Grade 2, 3, or 4 Laboratory Adverse Events	TDF/FTC	70	Participants
Grade 2, 3, or 4 Laboratory Adverse Events	Placebo	79	Participants
Grade 2, 3, or 4 Clinical Adverse Events	TDF/FTC	157	Participants
Grade 2, 3, or 4 Clinical Adverse Events	Placebo	162	Participants

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	TDF/FTC	1,251
Overall Study	STARTED	Placebo	1,248
Overall Study	COMPLETED	TDF/FTC	942
Overall Study	COMPLETED	Placebo	953
Overall Study	NOT COMPLETED	TDF/FTC	309
Overall Study	NOT COMPLETED	Placebo	295

Source ClinicalTrials.gov

Adverse events56

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	PHARYNGITIS	Respiratory, thoracic and mediastinal disorders	TDF/FTC	248	1,226	248
other	PHARYNGITIS	Respiratory, thoracic and mediastinal disorders	Placebo	282	1,230	282
other	PARASITIC INFECTION INTESTINAL	Gastrointestinal disorders	TDF/FTC	231	1,226	231
other	PARASITIC INFECTION INTESTINAL	Gastrointestinal disorders	Placebo	216	1,230	216
other	ALANINE AMINOTRANSFERASE INCREASED	Investigations	TDF/FTC	151	1,226	151
other	ALANINE AMINOTRANSFERASE INCREASED	Investigations	Placebo	155	1,230	155
other	BILIRUBIN INCREASE	Investigations	TDF/FTC	127	1,226	127
other	BILIRUBIN INCREASE	Investigations	Placebo	132	1,230	132
other	DIARRHOEA	Gastrointestinal disorders	TDF/FTC	109	1,226	109
other	DIARRHOEA	Gastrointestinal disorders	Placebo	123	1,230	123

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TDF/FTC
Total, all-cause mortality	Placebo
Total, other adverse events	TDF/FTC	906	1,226
Total, other adverse events	Placebo	937	1,230
Total, serious adverse events	TDF/FTC	92	1,226
Total, serious adverse events	Placebo	94	1,230

Source ClinicalTrials.gov

Papers13

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21091279	RESULT	PubMed
23435697	DERIVED	PubMed
24613084	DERIVED	PubMed
24740633	DERIVED	PubMed
25230290	DERIVED	PubMed
25908682	DERIVED	PubMed
26797207	DERIVED	PubMed
27572401	DERIVED	PubMed
27658870	DERIVED	PubMed
28639995	DERIVED	PubMed

1 to 10 of 13

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Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01AI064002	Chemoprophylaxis for HIV Prevention in Men	GRANT, ROBERT M.	J. DAVID GLADSTONE INSTITUTES	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2005 to 2011

Source NIH RePORTER

Trial comparisons11

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

Comparison	Source
TDF/FTC vs Placebo: Grade 3 or Higher Phosphorous Toxicity	Trial comparisons
TDF/FTC vs Placebo: Incidence of Confirmed Syphilis During Follow-Up	Trial comparisons
TDF/FTC vs Placebo: Grade 1 or Higher Creatinine Toxicity	Trial comparisons
TDF/FTC vs Placebo: Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis	Trial comparisons
TDF/FTC vs Placebo: HIV Seroconversion	Trial comparisons
TDF/FTC vs Placebo: Incidence of HSV-2 During the Follow-up Period	Trial comparisons
TDF/FTC vs Placebo: Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status.	Trial comparisons
TDF/FTC vs Placebo: Diagnosis of Gonorrhea During the Follow-up Period	Trial comparisons
TDF/FTC vs Placebo: Grade 2, 3, or 4 Laboratory Adverse Events	Trial comparisons
TDF/FTC vs Placebo: Grade 2, 3, or 4 Clinical Adverse Events	Trial comparisons

1 to 10 of 11

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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.

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