Trial · NCT00552240
Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)
NCT00552240, Phase 4, Completed, Boehringer Ingelheim; results first posted 2011-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT). Trials, record NCT00552240. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00552240
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nevirapine vs. Atazanavir Boosted With Ritonavir on a Background of Truvada in Human Immunodeficiency Virus (HIV) Infected Naive Patients (NEwArT)
- NCT number
- NCT00552240
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 154 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- HIV Infections
- Interventions
- tenofovir DF 300 mg QD, tenofovir DF 300 mg QD, emtricitabine 200 mg QD, emtricitabine 200 mg QD, Nevirapine 200 mg BID, Atazanavir 300 mg, Ritonavir 100 mg
- First posted
- 2007-11-01
- Last updated
- 2014-01-27
- Results first posted
- 2011-05-23
Source ClinicalTrials.gov
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Virologic Response (VR) | baseline to week 48 | VR is defined as HIV viral load of \<50 copies/ml measured at two consecutive visits PRIOR TO Week 48 and without subsequent rebound or change of ARV therapy prior to Week 48. |
| Secondary | Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm | baseline to week 48 | HIV viral load \<50 copies/ml measured at two consecutive visits UP TO Week 48 and without subsequent rebound or change of ARV therapy up to Week 48. |
| Secondary | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 | baseline to week 48 | HIV viral load \<50 copies/ml measured at Week 48 among observed cases on-treatment. |
| Secondary | Number of Participants With Virologic Success (FDA Definition) | baseline to week 48 | HIV viral load \<50 copies/ml measured in the Week 48 window whereby patients withdrawing early and patients without a Week 48 assessment are considered failures. Includes all participants in full analysis set (FAS). |
| Secondary | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants | baseline to week 48 | Time to response whereby patients withdrawing early were censored after their withdrawal |
| Secondary | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml | baseline to week 48 | |
| Secondary | Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response | baseline to week 24 and week 48 | HIV viral load \> 50 copies/ml on two consecutive measurements separated by at least 2 weeks, after confirmed virologic response (2 consecutive HIV viral load values \< 50 copies/ml) |
| Secondary | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment | baseline to week 2 | Results within time windows, patients on-treatment |
| Secondary | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment | baseline to week 4 | Results within time windows, patients on-treatment |
| Secondary | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment | baseline to week 6 | Results within time windows, patients on-treatment |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes48
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 (VR) | baseline to week 48 | All treated patients. Early withdrawals were considered failures. | participants | NUMBER |
| SECONDARY | Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm | baseline to week 48 | All treated patients. Early withdrawals were considered failures. | Participants | NUMBER |
| SECONDARY | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 | baseline to week 48 | Only includes treated patients with data in the Week 48 time window. | Participants | NUMBER |
| SECONDARY | Number of Participants With Virologic Success (FDA Definition) | baseline to week 48 | All treated patients. | Participants | NUMBER |
| SECONDARY | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants | baseline to week 48 | All treated patients | days | MEDIAN |
| SECONDARY | Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml | baseline to week 48 | All responders | days | MEDIAN |
| SECONDARY | Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response | baseline to week 24 and week 48 | All treated patients; Too few patients had a loss of virologic response for a reasonable analysis of time to loss. | Participants | NUMBER |
| SECONDARY | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment | baseline to week 2 | All treated patients | Participants | NUMBER |
| SECONDARY | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment | baseline to week 4 | All treated patients | Participants | NUMBER |
| SECONDARY | Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment | baseline to week 6 | All treated patients | Participants | NUMBER |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 outcomesResults by group192
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 (VR) | Nevirapine (NVP) Plus Truvada | Responders | 46 | participants | |
| Number of Participants With Virologic Response (VR) | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Responders | 50 | participants | |
| Number of Participants With Virologic Response (VR) | Nevirapine (NVP) Plus Truvada | Nonresponders | 29 | participants | |
| Number of Participants With Virologic Response (VR) | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Nonresponders | 27 | participants | |
| Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm | Nevirapine (NVP) Plus Truvada | Responders | 48 | Participants | |
| Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Responders | 51 | Participants | |
| Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm | Nevirapine (NVP) Plus Truvada | Nonresponders | 27 | Participants | |
| Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Nonresponders | 26 | Participants | |
| Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 | Nevirapine (NVP) Plus Truvada | Responders | 42 | Participants | |
| Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | Responders | 48 | Participants |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nevirapine (NVP) Plus Truvada | 75 | |
| Overall Study | STARTED | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 77 | |
| Overall Study | COMPLETED | Nevirapine (NVP) Plus Truvada | 51 | |
| Overall Study | COMPLETED | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 59 | |
| Overall Study | NOT COMPLETED | Nevirapine (NVP) Plus Truvada | 24 | |
| Overall Study | NOT COMPLETED | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 18 |
Source ClinicalTrials.gov
Adverse events90
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 | Upper respiratory tract infection | Infections and infestations | Nevirapine (NVP) Plus Truvada | 8 | 75 | |
| other | Upper respiratory tract infection | Infections and infestations | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 18 | 77 | |
| other | Sinusitis | Infections and infestations | Nevirapine (NVP) Plus Truvada | 3 | 75 | |
| other | Sinusitis | Infections and infestations | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 7 | 77 | |
| other | Anogenital warts | Infections and infestations | Nevirapine (NVP) Plus Truvada | 1 | 75 | |
| other | Anogenital warts | Infections and infestations | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 6 | 77 | |
| other | Bronchitis | Infections and infestations | Nevirapine (NVP) Plus Truvada | 2 | 75 | |
| other | Bronchitis | Infections and infestations | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 5 | 77 | |
| other | Insomnia | Psychiatric disorders | Nevirapine (NVP) Plus Truvada | 4 | 75 | |
| other | Insomnia | Psychiatric disorders | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 7 | 77 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nevirapine (NVP) Plus Truvada | ||
| Total, all-cause mortality | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | ||
| Total, other adverse events | Nevirapine (NVP) Plus Truvada | 50 | 75 |
| Total, other adverse events | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 61 | 77 |
| Total, serious adverse events | Nevirapine (NVP) Plus Truvada | 10 | 75 |
| Total, serious adverse events | Atazanavir Plus Ritonavir (ATV/r) Plus Truvada | 7 | 77 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nevirapine (NVP) Plus Truvada vs Atazanavir Plus Ritonavir (ATV/r) Plus Truvada: Proportion of Patients Reporting CNS Side Effects of Any Severity | Trial comparisons |
| Nevirapine (NVP) Plus Truvada vs Atazanavir Plus Ritonavir (ATV/r) Plus Truvada: Proportion of Patients Reporting Rash of Any Severity | Trial comparisons |
Nevirapine (NVP) Plus Truvada vs Atazanavir Plus Ritonavir (ATV/r) Plus Truvada: AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death | Trial comparisons |
| Nevirapine (NVP) Plus Truvada vs Atazanavir Plus Ritonavir (ATV/r) Plus Truvada: Proportion of Patients Reporting Hepatic Events of Any Severity | Trial comparisons |
| Nevirapine (NVP) Plus Truvada vs Atazanavir Plus Ritonavir (ATV/r) Plus Truvada: serious adverse events | 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/NCT00552240
GET https://conductscience.org/api/trials/v1/NCT00552240/registered?page=2