Trial · NCT00625404

FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women

NCT00625404, Phase 3, Completed, FHI 360; results first posted 2014-04-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women. Trials, record NCT00625404. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00625404

On this page

Trial

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

Title: FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women
NCT number: NCT00625404
Status: Completed
Phases: Phase 3
Enrollment: 2,120 participants, actual
Lead sponsor: FHI 360
Conditions: HIV Infections
Interventions: Truvada, Placebo
First posted: 2008-02-28
Last updated: 2018-07-26
Results first posted: 2014-04-16

Source ClinicalTrials.gov

Registered outcomes12

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

List	Outcome	Time frame	Description
Primary	HIV Infection	Cumulative HIV infection between enrollment and 52 weeks	HIV Seroconversion, with time to infection refined based on PCR results obtained from stored specimens.
Primary	Confirmed Grade 2 or Higher Serum Creatinine Toxicity	cumulative toxicity through 52 weeks of product use and 4 weeks post product	Repeat specimens were collected to confirm chemistry toxicities. Grade 2 or higher serum creatinine toxicity was defined as ≥1.4 times the upper limit of normal
Primary	Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration	10-26 months per site	The total number of adverse events in the placebo and Truvada arms during and within 4 weeks after study product administration.
Primary	Confirmed Grade 3 or Higher Reduction in Phosphorus	Through 52 weeks on product and 4 weeks post-product	Repeat specimens were collected to confirm chemistry toxicities. Grade 3 phosphorus reduction was defined as ≤2.4mg/dL
Primary	Confirmed Grade 3 or Higher ALT Elevation	Through 52 weeks on product and 4 weeks post-product	Grade 3 or higher ALT elevation was defined as ≥ 2.6 times the upper limit of normal
Primary	Confirmed Grade 3 or Higher AST Elevation	Through 52 weeks on product and 4 weeks post-product	Grade 3 or higher AST elevation was defined as ≥ 2.6 times the upper limit of normal
Secondary	Plasma HIV RNA Level (HIV-1 Viral Load)	up to 16 weeks	Viral load at the time of HIV detection, HIV conversion and through 16 weeks
Secondary	CD4+ T-cell Count	Up to 16 weeks	CD4+ T-cell Count at the Time of HIV Seroconversion through 16 weeks
Secondary	FTC and/or Tenofovir Resistance	up to 52 weeks	Genotypic resistance to FTC and/or tenofovir at the time of HIV diagnosis and 4 weeks later. If resistance was present, testing was repeated at weeks 12, 24, 36 and 52 as necessary (resistance testing will stop if no resistance is detected). participants were classified as having resistance if they had one or more visits in which resistance was detected, even if the resistance became undetectable over time.
Secondary	Pregnancy Complications	up to 60 weeks	Reported complications during pregnancy, including spontaneous abortion, vaginal or uterine bleeding, emergency c-section and other complications

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	HIV Infection	Cumulative HIV infection between enrollment and 52 weeks	All randomized participants who made at least one follow-up visit and were not HIV-positive at enrollment were included in the analysis population	participants	NUMBER
PRIMARY	Confirmed Grade 2 or Higher Serum Creatinine Toxicity	cumulative toxicity through 52 weeks of product use and 4 weeks post product	The Safety Population consisted of all women who were randomized and who had at least one follow-up visit and did not return all of their product un-used. Only women assessed for a particular safety outcome were included in analysis of that outcome.	participants	NUMBER
PRIMARY	Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration	10-26 months per site	The Safety Population, a subset of the ITT Population, excludes participants who never received study product, returned all product unused, or never returned for a follow-up visit. Analyses were performed by randomly assigned treatment group.	Number of adverse events	NUMBER
PRIMARY	Confirmed Grade 3 or Higher Reduction in Phosphorus	Through 52 weeks on product and 4 weeks post-product		participants	NUMBER
PRIMARY	Confirmed Grade 3 or Higher ALT Elevation	Through 52 weeks on product and 4 weeks post-product		participants	NUMBER
PRIMARY	Confirmed Grade 3 or Higher AST Elevation	Through 52 weeks on product and 4 weeks post-product		participants	NUMBER
SECONDARY	Plasma HIV RNA Level (HIV-1 Viral Load)	up to 16 weeks	68 women who became infected post-enrollment were included in viral load analyses. Only 48 of these women (27 on Truvada and 21 on placebo) contributed a specimen sample for analysis at the 16-weeks post seroconversion visit	log copies/mL	LOG_MEAN
SECONDARY	CD4+ T-cell Count	Up to 16 weeks		cells/mL	MEAN
SECONDARY	FTC and/or Tenofovir Resistance	up to 52 weeks	All women who seroconverted were assessed for possible resistance.	participants	NUMBER
SECONDARY	Pregnancy Complications	up to 60 weeks	Women becoming pregnant during regular follow-up in the study (70 in Truvada group and 45 in placebo group)	participants	NUMBER

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group24

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

Outcome	Group	Value	Spread	Units
HIV Infection	Truvada Arm	33	3.25 to 6.63	participants
HIV Infection	Placebo Arm	35	3.47 to 6.93	participants
Confirmed Grade 2 or Higher Serum Creatinine Toxicity	Truvada Arm	4		participants
Confirmed Grade 2 or Higher Serum Creatinine Toxicity	Placebo Arm	2		participants
Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration	Truvada Arm	2257		Number of adverse events
Frequency of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration	Placebo Arm	2384		Number of adverse events
Confirmed Grade 3 or Higher Reduction in Phosphorus	Truvada Arm	45		participants
Confirmed Grade 3 or Higher Reduction in Phosphorus	Placebo Arm	40		participants
Confirmed Grade 3 or Higher ALT Elevation	Truvada Arm	6		participants
Confirmed Grade 3 or Higher ALT Elevation	Placebo Arm	8		participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Truvada Arm	1,062
Overall Study	STARTED	Placebo Arm	1,058
Overall Study	COMPLETED	Truvada Arm	855
Overall Study	COMPLETED	Placebo Arm	885
Overall Study	NOT COMPLETED	Truvada Arm	207
Overall Study	NOT COMPLETED	Placebo Arm	173

Source ClinicalTrials.gov

Adverse events530

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	Anaemia	Blood and lymphatic system disorders	Truvada Arm	6	1,025	6
other	Anaemia	Blood and lymphatic system disorders	Placebo Arm	5	1,033	6
other	Lymphadenopathy	Blood and lymphatic system disorders	Truvada Arm	1	1,025	1
other	Lymphadenopathy	Blood and lymphatic system disorders	Placebo Arm	1	1,033	1
other	Palpitations	Cardiac disorders	Truvada Arm	1	1,025	1
other	Palpitations	Cardiac disorders	Placebo Arm	2	1,033	2
other	Exomphalos	Congenital, familial and genetic disorders	Truvada Arm	1	1,025	1
other	Exomphalos	Congenital, familial and genetic disorders	Placebo Arm	1	1,033	1
other	Ear pain	Ear and labyrinth disorders	Truvada Arm	1	1,025	1
other	Ear pain	Ear and labyrinth disorders	Placebo Arm	5	1,033	5

1 to 10 of 530Source ClinicalTrials.gov

See all 530 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Truvada Arm
Total, all-cause mortality	Placebo Arm
Total, other adverse events	Truvada Arm	761	1,025
Total, other adverse events	Placebo Arm	749	1,033
Total, serious adverse events	Truvada Arm	33	1,025
Total, serious adverse events	Placebo Arm	23	1,033

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22784040	DERIVED	PubMed
25459097	DERIVED	PubMed
25503265	DERIVED	PubMed
25539648	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 comparisons8

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

Comparison	Source
Truvada Arm vs Placebo Arm: HIV Infection	Trial comparisons
Truvada Arm vs Placebo Arm: Pregnancy Complications	Trial comparisons
Truvada Arm vs Placebo Arm: Confirmed Grade 2 or Higher Serum Creatinine Toxicity	Trial comparisons
Truvada Arm vs Placebo Arm: Confirmed Grade 3 or Higher ALT Elevation	Trial comparisons
Truvada Arm vs Placebo Arm: Confirmed Grade 3 or Higher AST Elevation	Trial comparisons
Truvada Arm vs Placebo Arm: Confirmed Grade 3 or Higher Reduction in Phosphorus	Trial comparisons
Truvada Arm vs Placebo Arm: FTC and/or Tenofovir Resistance	Trial comparisons
Truvada Arm vs Placebo Arm: 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/NCT00625404

GET https://conductscience.org/api/trials/v1/NCT00625404/results?page=2

API reference For AI assistants