Outcomes12

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

1 to 12 of 12

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
SECONDARY	Pill Counts and Participant Report of Adherence to Once-daily Pill Taking	Up to 52 weeks	All randomized participants who completed at least one follow-up visit, excluding women found to have been infected at enrollment	percentage of days	MEAN
SECONDARY	Participant Report of Change in Number of Sexual Partners	Up to 52 weeks	Women reporting on sexual behavior during follow-up	mean number of sexual partners	MEAN

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

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

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