Registered outcomes12

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

1 to 12 of 12

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
Secondary	Pill Counts and Participant Report of Adherence to Once-daily Pill Taking	Up to 52 weeks	Pill counts and participant report of adherence to once-daily pill taking reported as mean days study product could have been used according to pill counts
Secondary	Participant Report of Change in Number of Sexual Partners	Up to 52 weeks	Difference in mean number of reported sexual partners between final study visit and enrollment visit

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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 list from software.

Twenty rows a page, as JSON. No key.

GET https://conductscience.org/api/trials/v1/NCT00625404/registered

API reference For AI assistants