Trial · NCT00389207

Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults

NCT00389207, Phase 3, Completed, Boehringer Ingelheim; results first posted 2012-03-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults. Trials, record NCT00389207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00389207

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Nevirapine or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir in Human Immunodeficiency Virus (HIV)-1-infected Treatment Naive Adults
NCT number: NCT00389207
Status: Completed
Phases: Phase 3
Enrollment: 576 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: HIV Infections
Interventions: nevirapine bid, nevirapine qd, atazanavir
First posted: 2006-10-18
Last updated: 2014-01-27
Other registries' IDs: eudract:2005-004330-40
Results first posted: 2012-03-26

Source ClinicalTrials.gov

Registered outcomes34

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment Response at Week 48	From baseline to Week 48	Treatment response is defined as a viral load (VL) \<50 copies/mL measured at two consecutive visits prior to Week 48 and without subsequent rebound or change of antiretroviral (ARV) therapy prior to Week 48.
Secondary	Treatment Response at Week 48 (TLOVR Algorithm)	From baseline to Week 48	Treatment response is defined as a VL \<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, based on time to loss of virologic response (TLOVR) algorithm, as a sensitivity analysis for the primary analysis.
Secondary	Proportion of Patients With VL < 50 Copies/ml	From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT	VL \<50 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT) for the patient
Secondary	Proportion of Patients With VL < 400 Copies/ml	From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT	VL \<400 copies/mL among observed patients on treatment at each visit, with the final visit at Week 144 or end of trial (EOT)
Secondary	Change in CD4+ Count From Baseline	From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT	Change in CD4+ cell count from baseline among patients on treatment at each visit, with the final visit at Week 144 or EOT
Secondary	Change in Framingham Score From Baseline	From baseline to Weeks 48, 96 and 144/EOT	Change in the estimated risk of cardiovascular disease using the Framingham algorithm from baseline to after 48, 96 and 144 weeks, last observation carried forward (LOCF). The score is based on age, gender, systolic blood pressure, total cholesterol, high density lipoprotein cholesterol and smoking status. Scores range from 0 to 21 with higher scores indicating a greater risk.
Secondary	Change in Mental Health Summary (MHS) Score From Baseline	From baseline to Weeks 48, 96 and 144/EOT	Quality of life (QoL) assessment by change in MHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the Medical Outcomes Study HIV Health Survey (MOS-HIV), a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The MHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.
Secondary	Change in Physical Health Summary (PHS) Score From Baseline	From baseline to Weeks 48, 96 and 144/EOT	QoL assessment by change in PHS score from baseline to after 48, 96 and 144 weeks (observed cases), from the MOS-HIV, a 35-item self-administered questionnaire including 10 scales covering: health perceptions, pain, physical functioning, role functioning, social and cognitive functioning, mental health, energy/fatigue, health distress, and QoL. The PHS is a weighted average of the 10 scales and ranges from 0 to 100 with higher scores indicating better QoL.
Secondary	Number of Patients Hospitalized	From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT	Cost effectiveness assessment by number of patients hospitalized
Secondary	Non-scheduled Physician Visits	From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT	Cost effectiveness assessment by number of patients with non-scheduled physician visits

1 to 10 of 34Source ClinicalTrials.gov

See all 34 registered outcomes

Outcomes34

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment Response at Week 48	From baseline to Week 48	Full Analysis Set (FAS) defined as all randomized and treated patients but numbers are reduced as indicated due to empty cells in analyses adjusting for baseline categories	Patients	NUMBER
SECONDARY	Treatment Response at Week 48 (TLOVR Algorithm)	From baseline to Week 48	FAS but numbers are reduced as indicated due to empty cells in analysis adjusting for baseline categories	Patients	NUMBER
SECONDARY	Proportion of Patients With VL < 50 Copies/ml	From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT	FAS with varying numbers missing or not on treatment per visit	Proportion of patients	NUMBER
SECONDARY	Proportion of Patients With VL < 400 Copies/ml	From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT	FAS with varying numbers missing or not on treatment per visit	Proportion of patients	NUMBER
SECONDARY	Change in CD4+ Count From Baseline	From baseline to Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132 and 144/EOT	FAS with varying numbers missing or not on treatment per visit	cells/mm^3	MEAN
SECONDARY	Change in Framingham Score From Baseline	From baseline to Weeks 48, 96 and 144/EOT	FAS with varying numbers missing	Units on a scale	MEAN
SECONDARY	Change in Mental Health Summary (MHS) Score From Baseline	From baseline to Weeks 48, 96 and 144/EOT	FAS with varying numbers missing	Units on a scale	MEAN
SECONDARY	Change in Physical Health Summary (PHS) Score From Baseline	From baseline to Weeks 48, 96 and 144/EOT	FAS with varying numbers missing	Units on a scale	MEAN
SECONDARY	Number of Patients Hospitalized	From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT	FAS with varying numbers missing	Patients	NUMBER
SECONDARY	Non-scheduled Physician Visits	From baseline to Week 24, Week 24 to 48, Week 48 to 96, and Week 96 to 144/EOT	FAS with varying numbers missing	patients	NUMBER

1 to 10 of 34Source ClinicalTrials.gov

See all 34 outcomes

Results by group330

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Treatment Response at Week 48	Nevirapine QD	Number of responders	126	Patients
Treatment Response at Week 48	Nevirapine BID	Number of responders	124	Patients
Treatment Response at Week 48	Nevirapine QD+BID	Number of responders	250	Patients
Treatment Response at Week 48	Atazanvir/Ritonavir	Number of responders	126	Patients
Treatment Response at Week 48	Nevirapine QD	Number of non-responders	62	Patients
Treatment Response at Week 48	Nevirapine BID	Number of non-responders	64	Patients
Treatment Response at Week 48	Nevirapine QD+BID	Number of non-responders	126	Patients
Treatment Response at Week 48	Atazanvir/Ritonavir	Number of non-responders	67	Patients
Treatment Response at Week 48 (TLOVR Algorithm)	Nevirapine QD+BID	Number of responders	261	Patients
Treatment Response at Week 48 (TLOVR Algorithm)	Atazanvir/Ritonavir	Number of responders	142	Patients

1 to 10 of 330Source ClinicalTrials.gov

See all 330 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nevirapine QD	188
Overall Study	STARTED	Nevirapine BID	188
Overall Study	STARTED	Atazanvir/Ritonavir	193
Overall Study	COMPLETED	Nevirapine QD	125
Overall Study	COMPLETED	Nevirapine BID	116
Overall Study	COMPLETED	Atazanvir/Ritonavir	152
Overall Study	NOT COMPLETED	Nevirapine QD	63
Overall Study	NOT COMPLETED	Nevirapine BID	72
Overall Study	NOT COMPLETED	Atazanvir/Ritonavir	41

Source ClinicalTrials.gov

Adverse events435

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
other	Ocular icterus	Eye disorders	Nevirapine QD	0	188
other	Ocular icterus	Eye disorders	Nevirapine BID	0	188
other	Ocular icterus	Eye disorders	Atazanvir/Ritonavir	14	193
other	Abdominal pain	Gastrointestinal disorders	Nevirapine QD	5	188
other	Abdominal pain	Gastrointestinal disorders	Nevirapine BID	10	188
other	Abdominal pain	Gastrointestinal disorders	Atazanvir/Ritonavir	15	193
other	Abdominal pain upper	Gastrointestinal disorders	Nevirapine QD	9	188
other	Abdominal pain upper	Gastrointestinal disorders	Nevirapine BID	14	188
other	Abdominal pain upper	Gastrointestinal disorders	Atazanvir/Ritonavir	13	193
other	Diarrhoea	Gastrointestinal disorders	Nevirapine QD	29	188

1 to 10 of 435Source ClinicalTrials.gov

See all 435 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nevirapine QD
Total, all-cause mortality	Nevirapine BID
Total, all-cause mortality	Atazanvir/Ritonavir
Total, other adverse events	Nevirapine QD	136	188
Total, other adverse events	Nevirapine BID	141	188
Total, other adverse events	Atazanvir/Ritonavir	161	193
Total, serious adverse events	Nevirapine QD	25	188
Total, serious adverse events	Nevirapine BID	31	188
Total, serious adverse events	Atazanvir/Ritonavir	27	193

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21555816	DERIVED	PubMed
21628668	DERIVED	PubMed

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.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00389207

GET https://conductscience.org/api/trials/v1/NCT00389207/registered?page=2

API reference For AI assistants