Trial · NCT00608569
Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults
NCT00608569, Not applicable, Completed, Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections; results first posted 2013-11-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults. Trials, record NCT00608569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00608569
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Determining the Effects of Observed and Self-Administered Drug Regimens in HIV Infected Adults
- NCT number
- NCT00608569
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 529 participants, actual
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Conditions
- HIV Infections
- Interventions
- Lopinavir/ritonavir, Emtricitabine/Tenofovir disoproxil fumarate, Tenofovir disoproxil fumarate, Zidovudine, Emtricitabine
- First posted
- 2008-02-06
- Last updated
- 2018-10-12
- Results first posted
- 2013-11-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Confirmed Virologic Failure at or Prior to Week 48 | At or prior to Week 48 | Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) \<1 log10 copies/mL below the baseline level and \>400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) \>400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤50 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 48 was reported. |
| Secondary | Confirmed Virologic Failure at or Prior to Week 24 | At or prior to Week 24 | Confirmed virologic failure was defined as two successive HIV-1 RNA measurements at least 24 hours apart that were either:1) \<1 log10 copies/mL below the baseline level and \>400 copies/mL at the week 12 HIV-1 RNA evaluation (obtained at least 11 weeks after the date of the randomization) 2) \>400 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 23 weeks after the date of randomization). 3) subjects who discontinued the study follow-up for any reason other than study completion, including death, and who did so ≤30 weeks after randomization was considered to be a virologic failure. Number of participants experiencing or not experiencing virologic failure at or prior to week 24 was reported. |
| Secondary | CD4 Count at Follow-up Visits | At Weeks 4, 12, 24, 36, and 48 | CD4 cell count (median, inter-quartile range) |
| Secondary | CD8 Count at Follow-up Visits | At week 4, 12, 24, 36, and 48 | CD8 cell count (median, inter-quartile range) |
| Secondary | Time to First Grade 3 or 4 Lab Event | 52 weeks since randomization | 5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab event |
| Secondary | Time to First Grade 3 or 4 Sign or Symptom | 52 weeks since randomization | 5th and 10th percentiles in weeks from randomization to first grade 3 or 4 sign or symptom |
| Secondary | Time to First Grade 3 or 4 Lab or Sign/Symptom Event | 52 weeks since randomization | 5th and 10th percentiles in weeks from randomization to first grade 3 or 4 lab or sign/ symptom event |
| Secondary | Adherence to Second Line HAART Regimen | At weeks 4, 8, 12, 24, 36, 48 and 52 | Number of participants with self-reported 100% adherence over the week prior to study visit |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Confirmed Virologic Failure at or Prior to Week 48 | At or prior to Week 48 | Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed. | participants | NUMBER |
| SECONDARY | Confirmed Virologic Failure at or Prior to Week 24 | At or prior to Week 24 | Two hundred fifty seven eligible participants were included in the analysis. Intent to treat analysis was performed. | participants | NUMBER |
| SECONDARY | CD4 Count at Follow-up Visits | At Weeks 4, 12, 24, 36, and 48 | cells/mm3 | MEDIAN | |
| SECONDARY | CD8 Count at Follow-up Visits | At week 4, 12, 24, 36, and 48 | cells/mm3 | MEDIAN | |
| SECONDARY | Time to First Grade 3 or 4 Lab Event | 52 weeks since randomization | Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed. | weeks | NUMBER |
| SECONDARY | Time to First Grade 3 or 4 Sign or Symptom | 52 weeks since randomization | Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed. | weeks | NUMBER |
| SECONDARY | Time to First Grade 3 or 4 Lab or Sign/Symptom Event | 52 weeks since randomization | Two hundred fifty seven eligible participants were included in the analysis. As-treated analysis was performed. | weeks | NUMBER |
| SECONDARY | Adherence to Second Line HAART Regimen | At weeks 4, 8, 12, 24, 36, 48 and 52 | Only the 257 eligible participants were included in the analysis. Self-reported adherence was collected face-to-face or by self-report on the Adherence/Quality of Life/Psychosocial Interview form. Only adherence to LPV/rtv was collected. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Confirmed Virologic Failure at or Prior to Week 48 | mDOT Arm | No Failure | 95 | participants | |
| Confirmed Virologic Failure at or Prior to Week 48 | Non-mDOT Arm | No Failure | 105 | participants | |
| Confirmed Virologic Failure at or Prior to Week 48 | mDOT Arm | Experienced Failure | 34 | participants | |
| Confirmed Virologic Failure at or Prior to Week 48 | Non-mDOT Arm | Experienced Failure | 23 | participants | |
| Confirmed Virologic Failure at or Prior to Week 24 | mDOT Arm | No Failure | 105 | participants | |
| Confirmed Virologic Failure at or Prior to Week 24 | Non-mDOT Arm | No Failure | 111 | participants | |
| Confirmed Virologic Failure at or Prior to Week 24 | mDOT Arm | Experienced Failure | 24 | participants | |
| Confirmed Virologic Failure at or Prior to Week 24 | Non-mDOT Arm | Experienced Failure | 17 | participants | |
| CD4 Count at Follow-up Visits | mDOT Arm | Week 4 | 212 | Inter-Quartile Range 129 to 309 | cells/mm3 |
| CD4 Count at Follow-up Visits | Non-mDOT Arm | Week 4 | 219 | Inter-Quartile Range 158 to 289 | cells/mm3 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | mDOT Arm | 129 | |
| Overall Study | STARTED | Non-mDOT Arm | 128 | |
| Overall Study | COMPLETED | mDOT Arm | 119 | |
| Overall Study | COMPLETED | Non-mDOT Arm | 119 | |
| Overall Study | NOT COMPLETED | mDOT Arm | 10 | |
| Overall Study | NOT COMPLETED | Non-mDOT Arm | 9 |
Source ClinicalTrials.gov
Adverse events62
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 | Abdominal pain | Gastrointestinal disorders | mDOT Arm | 4 | 129 | |
| other | Abdominal pain | Gastrointestinal disorders | Non-mDOT Arm | 9 | 128 | |
| other | Diarrhoea | Gastrointestinal disorders | mDOT Arm | 16 | 129 | |
| other | Diarrhoea | Gastrointestinal disorders | Non-mDOT Arm | 18 | 128 | |
| other | Vomiting | Gastrointestinal disorders | mDOT Arm | 6 | 129 | |
| other | Vomiting | Gastrointestinal disorders | Non-mDOT Arm | 9 | 128 | |
| other | Chest pain | General disorders | mDOT Arm | 7 | 129 | |
| other | Chest pain | General disorders | Non-mDOT Arm | 5 | 128 | |
| other | Pyrexia | General disorders | mDOT Arm | 11 | 129 | |
| other | Pyrexia | General disorders | Non-mDOT Arm | 15 | 128 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | mDOT Arm | ||
| Total, all-cause mortality | Non-mDOT Arm | ||
| Total, other adverse events | mDOT Arm | 94 | 129 |
| Total, other adverse events | Non-mDOT Arm | 98 | 128 |
| Total, serious adverse events | mDOT Arm | 6 | 129 |
| Total, serious adverse events | Non-mDOT Arm | 7 | 128 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI068636 | AIDS Clinical Trials Group Network | KURITZKES, DANIEL R. | SOCIAL AND SCIENTIFIC SYSTEMS, INC. | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| mDOT Arm vs Non-mDOT Arm: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT00608569
GET https://conductscience.org/api/trials/v1/NCT00608569/results?page=2