Trial · NCT00855413
HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine
NCT00855413, Phase 4, Terminated, University of North Carolina, Chapel Hill; results first posted 2017-10-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine. Trials, record NCT00855413. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00855413
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HIV Viremia and Persistence in Acutely HIV-Infected Patients Treated With Darunavir/Ritonavir and Etravirine
- NCT number
- NCT00855413
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 15 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Acute HIV Infection, HIV Infections
- Interventions
- Darunavir, Ritonavir, Etravirine
- First posted
- 2009-03-04
- Last updated
- 2017-10-17
- Results first posted
- 2017-10-17
- Limitations and caveats
Early termination prior to target enrollment due to slow enrollment limited analysis involving optional procedures. Lack of paired (baseline and followup) samples from optional procedures also limited ability to perform these analyses.
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Virologic Response | 24 weeks | Virologic response defined as plasma HIV RNA measurement \<200 copies/mL at week 24 |
| Secondary | Number of Participants With Virologic Response | 48 weeks from enrollment | Virologic response to study treatment defined as plasma HIV RNA measurement \<50 copies/mL at week 48 |
| Secondary | Median Change in CD4 Cell Count From Week 0 to Week 24. | week 0, week 24 | |
| Secondary | Median Change in CD4 Cell Count From Week 0 to Week 48. | 48 weeks from enrollment | |
| Secondary | HIV RNA Levels Immediately Prior to Initiating Study Treatment. | HIV RNA level at enrollment | |
| Secondary | Median Time to HIV RNA Suppression to <200 Copies/mL | From enrollment to the date of HIV RNA suppression, assessed up to Week 48 | |
| Secondary | HIV RNA Detection in Semen | From enrollment through 48 weeks | Total cumulative levels of HIV RNA detected in the semen of participants from enrollment through week 48. |
| Secondary | Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance | Enrollment to Week 48 | |
| Secondary | Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48 | Enrollment to week 48 | Total number of adverse events observed that were possibly or definitely related to study treatment through week 48 |
| Secondary | Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture | Week 4 and week 48 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Virologic Response | 24 weeks | All participants enrolled were included in analysis of virologic response | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Virologic Response | 48 weeks from enrollment | All participants retained on study through week 48 were included in the analysis of virologic efficacy at week 48 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Change in CD4 Cell Count From Week 0 to Week 24. | week 0, week 24 | All participants enrolled were included in this analysis | cells/mm^3 | MEDIAN |
| SECONDARY | Median Change in CD4 Cell Count From Week 0 to Week 48. | 48 weeks from enrollment | 12 participants with a week 48 study visit were included in analysis | cells/mm^3 | MEDIAN |
| SECONDARY | HIV RNA Levels Immediately Prior to Initiating Study Treatment. | HIV RNA level at enrollment | copies/mL | MEDIAN | |
| SECONDARY | Median Time to HIV RNA Suppression to <200 Copies/mL | From enrollment to the date of HIV RNA suppression, assessed up to Week 48 | days | MEDIAN | |
| SECONDARY | HIV RNA Detection in Semen | From enrollment through 48 weeks | Study stopped prior to target enrollment by sponsor. Given insufficient semen samples, correlation of HIV viremia in semen with time to suppression was not performed due to inadequate power to analyze the outcome. | copies/mL | MEAN |
| SECONDARY | Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance | Enrollment to Week 48 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48 | Enrollment to week 48 | adverse events | NUMBER | |
| SECONDARY | Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture | Week 4 and week 48 | 4 participants consented to 7 optional lumbar punctures to provide CSF samples for measurement of drug levels. | ng/mL | NUMBER |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Virologic Response | Acute HIV Infection Treatment Group | 13 | Participants | ||
| Number of Participants With Virologic Response | Acute HIV Infection Treatment Group | 9 | Participants | ||
| Median Change in CD4 Cell Count From Week 0 to Week 24. | Acute HIV Infection Treatment Group | 158 | Full Range -281 to 916 | cells/mm^3 | |
| Median Change in CD4 Cell Count From Week 0 to Week 48. | Acute HIV Infection Treatment Group | 349 | Full Range 7 to 495 | cells/mm^3 | |
| HIV RNA Levels Immediately Prior to Initiating Study Treatment. | Acute HIV Infection Treatment Group | 1,000,000 | Full Range 22,858 to 29,807,640 | copies/mL | |
| Median Time to HIV RNA Suppression to <200 Copies/mL | Acute HIV Infection Treatment Group | 59 | Full Range 15 to 187 | days | |
| HIV RNA Detection in Semen | Acute HIV Infection Treatment Group | 2541 | Full Range 0 to 7470 | copies/mL | |
| Number of Participants Who Stopped Study Treatment Due to Adverse Event or Intolerance | Acute HIV Infection Treatment Group | 1 | Participants | ||
| Adverse Events Possibly or Definitely Related to Study Treatment Through Week 48 | Acute HIV Infection Treatment Group | 13 | adverse events | ||
| Maximum Etravirine Exposure in Cerebrospinal Fluid Among Participants Who Consented to an Optional Lumbar Puncture | Acute HIV Infection Treatment Group | 25 | ng/mL |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acute HIV Infection Treatment Group | 15 | |
| Overall Study | COMPLETED | Acute HIV Infection Treatment Group | 15 | |
| Overall Study | NOT COMPLETED | Acute HIV Infection Treatment Group | 0 |
Source ClinicalTrials.gov
Adverse events5
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 | Blood Cholesterol Increased | Investigations | Darunavir/Ritonavir and Etravirine | 1 | 15 | 1 |
| other | Dizziness | Nervous system disorders | Darunavir/Ritonavir and Etravirine | 1 | 15 | 1 |
| other | Headache | Nervous system disorders | Darunavir/Ritonavir and Etravirine | 1 | 15 | 1 |
| other | Nausea | Gastrointestinal disorders | Darunavir/Ritonavir and Etravirine | 1 | 15 | 1 |
| other | Rash | Skin and subcutaneous tissue disorders | Darunavir/Ritonavir and Etravirine | 1 | 15 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Darunavir/Ritonavir and Etravirine | 0 | 15 |
| Total, other adverse events | Darunavir/Ritonavir and Etravirine | 4 | 15 |
| Total, serious adverse events | Darunavir/Ritonavir and Etravirine | 0 | 15 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Category Fluency | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Scan Task | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
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/NCT00855413
GET https://conductscience.org/api/trials/v1/NCT00855413/registered?page=2