Trial · NCT00458393
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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 |
| SECONDARY | Viral Load Among HIV Infected Participants | At the time closest to HIV detection | All HIV infections detected during the study including prior to, during and after study treatment | log RNA copies per ml | MEAN |
| SECONDARY | Among HIV Infected Participants Drug Resistance | at the time of HIV acquisition | There were 2 TDF/FTC seroconversions at enrollment and 48 during follow-up. There were 8 Placebo seroconversions at enrollment and 83 during follow-up. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | CD4 Count Among HIV Infected Participants | at the time infection was detected | HIV infected participants during the trial including those HIV+ at baseline | cells per cubic mm | MEAN |
| SECONDARY | Proportion of Missed Doses by Pill Count | At 24 weeks | Those who bottles returned at the week 24 visit. | proportion of pills not returned | MEAN |
| SECONDARY | Percentage of Missed Doses by Estimate During CASI Interview | Week 24 | All participants who answered the adherence question with an estimated adherence on the week 24 computer assisted structured interview | percentage of doses taken | MEAN |
| SECONDARY | Number of Condomless Sexual Partners With HIV Positive or Unknown Status | At 24 weeks | Participants interviewed about sexual practices at week 24 | count | MEDIAN |
| SECONDARY | Total Number of Sexual Partners | 24 weeks | Participants interviewed about sexual practices at week 24 | Count | MEDIAN |
| SECONDARY | Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status. | At 24 weeks | Participants interviewed about sexual practices at week 24 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Confirmed Syphilis During Follow-Up | All Follow-Up median of 1.2 years of follow-up | Participants without active syphilis at baseline with a follow-up syphilis test. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of HSV-2 During the Follow-up Period | Total study follow-up, a median of 1.2 years | All HSV-2 negative participants with a follow-up HSV-2 test. | Participants | COUNT_OF_PARTICIPANTS |
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/NCT00458393/outcomes