Trial · NCT00458393
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| 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 |
| Secondary | Viral Load Among HIV Infected Participants | At the time closest to HIV detection | HIV-RNA in log10 units among HIV infected participants at the time closest to HIV detection |
| Secondary | Among HIV Infected Participants Drug Resistance | at the time of HIV acquisition | Genotypic resistance by clinical assays among the seroconverters from baseline to the end of the study treatment period |
| Secondary | CD4 Count Among HIV Infected Participants | at the time infection was detected | CD4 cell count for HIV infected participants during the trial |
| Secondary | Proportion of Missed Doses by Pill Count | At 24 weeks | Estimated proportion of missed doses by pill count (assuming pills taken in unreturned bottles) |
| Secondary | Percentage of Missed Doses by Estimate During CASI Interview | Week 24 | Percentage of missed doses by estimate during computer assisted structured interview |
| Secondary | Number of Condomless Sexual Partners With HIV Positive or Unknown Status | At 24 weeks | Participants self-report of the number of sexual partners with HIV positive or unknown status in the previous 12 weeks with whom they had condomless anal sex |
| Secondary | Total Number of Sexual Partners | 24 weeks | Self-reported total number of sexual partners in the previous 12 weeks. |
| Secondary | Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status. | At 24 weeks | Self-reported condomless receptive anal intercourse in the previous 12 weeks with any partners regardless of status. |
| Secondary | Incidence of Confirmed Syphilis During Follow-Up | All Follow-Up median of 1.2 years of follow-up | Number of participants who have at least 1 confirmed syphilis infection during the study |
| Secondary | Incidence of HSV-2 During the Follow-up Period | Total study follow-up, a median of 1.2 years | Incidence of HSV-2 during the follow-up period among those HIV-2 negative at baseline |
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/registered