Nevirapine vs. Atazanavir Boosted With Ritonavir on a Bac... | NCT00552240

NCT00552240

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NVP 200mg bis indie (BID)	Active Comparator	after receiving nevirapine (NVP) 200 mg quaue die (QD) for 2 weeks, pt titrated to NVP 200 mg bis in die (BID) combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks	Drug: tenofovir DF 300 mg QD Drug: emtricitabine 200 mg QD Drug: Nevirapine 200 mg BID
Atazanavir 300 mg QD/ritonavir 100 mg QD	Active Comparator	patients to receive atazanavir 300 mg QD boosted with ritonavir 100 mg QD combined with emtricitabine 200 mg QD/ tenofovir DF 300 mg QD (fixed dose combination Truvada) for 48 weeks	Drug: tenofovir DF 300 mg QD Drug: emtricitabine 200 mg QD Drug: Atazanavir 300 mg Drug: Ritonavir 100 mg

Name	Type	Description	Arm Group Labels	Other Names
tenofovir DF 300 mg QD	Drug	300 mg QD	Atazanavir 300 mg QD/ritonavir 100 mg QD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Virologic Response (VR)	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.	baseline to week 48

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm	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.	baseline to week 48
Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation
HIV-1- infected males or females greater than or equal to 18 years of age with documented positive serology Enzyme-linked Immuno Sorbert Assay (ELISA) confirmed by Western blot
No prior nucleoside reverse transcriptase inhibitor (NRTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) use of more than 10 days AND
No prior use of other classes of antiretrovirals (ARVs) of more than 2 weeks duration
Males with CD4+ count less than 400 cells/mm cubed or females with CD4+ count less than 250 cells/mm cubed
NVP and ATV/r susceptibility on screening HIV-1 genotypic resistance assay
Adequate renal function defined as a calculated creatinine clearance greater than or equal to50 ml/min according to the Cockcroft-Gault formula
Karnofsky score greater than or equal to 70 (see Appendix 10.7)
Acceptable medical history, as assessed by the investigator

Exclusion criteria:

History of active drug or alcohol abuse within 2 years prior to study entry (at the investigators discretion)
Hepatic cirrhosis with stage Child-Pugh B or C hepatic impairment
Female patients of child-bearing potential who:

have a positive serum pregnancy test at screening, are breast feeding, are planning to become pregnant, are not willing to use a barrier method of contraception, or are not willing to use methods of contraception other than ethinyl estradiol containing oral contraceptives
Laboratory parameters greater than Division of Aids (National Institute of Health, USA) (DAIDS) grade 2 (triglycerides greater than DAIDS grade 3, total cholesterol no restrictions, see Appendix 10.1)
Active hepatitis B or C disease, defined as HBsAg-positive or Hepatitis C Virus (HCV) RNA positive with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ALT/AST greater than2.5x Upper Limit of Normal (ULN) (greater than DAIDS grade 1)
Known hypersensitivity to any ingredients in nevirapine or atazanavir
Patients who are receiving concomitant treatments which are not permitted, as listed in Appendix 10.6
Use of other investigational medications within 30 days before study entry or during the trial
Use of immunomodulatory drugs within 30 days before study entry or during the trial (e.g., interferon, cyclosporin, hydroxyurea, interleukin 2, chronic treatment with prednisone)
Patients with Progressive Multifocal Leukoencephalopathy (PML), visceral Kaposi's Sarcoma (KS), and/or any lymphoma
Any AIDS defining illness that is unresolved, symptomatic or not stable on treatment for at least 12 weeks at the screening visit
Patients who are receiving systemic chemotherapy

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1100.1512.28 Boehringer Ingelheim Investigational Site		Beverly Hills	California		United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
FG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Virologic Response (VR)

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.

All treated patients. Early withdrawals were considered failures.

Posted

Number

participants

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG00075 OG00177

Title

Denominators

Categories

Responders

Title	Measurements
	OG00046 OG00150

Nonresponders

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	With 75 evaluable patients per treatment group, this study had 80% power to observe a difference no lower than -6.5% assuming the true proportions of responders are both 65%.	Cochran-Mantel-Haenszel	Controlling for screening viral load and CD4+ categories	0.7142		Difference in proportion of responders	-0.041				95	-0.183	0.101				Yes	Non-Inferiority or Equivalence	A point estimate of -6.5% or higher for the diff. in the prop. of responders (NVP - ATV/r) was to be considered consistent with a successful ArTEN study. In the worst case for both studies, if the 2 studies were to be pooled, the non-inferiority margin of -12% would then be outside the 95% confidence interval (CI).

Secondary

Number of Participants With Virologic Response According to the Time to Loss of Virologic Response (TLOVR) Algorithm

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.

All treated patients. Early withdrawals were considered failures.

Posted

Number

Participants

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48

HIV viral load <50 copies/ml measured at Week 48 among observed cases on-treatment.

Only includes treated patients with data in the Week 48 time window.

Posted

Number

Participants

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With Virologic Success (FDA Definition)

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).

All treated patients.

Posted

Number

Participants

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), All Participants

Time to response whereby patients withdrawing early were censored after their withdrawal

All treated patients

Posted

Median

Inter-Quartile Range

days

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Time to Virologic Response (First Confirmed Viral Load < 50 Copies/ml), Only Participants With Confirmed Viral Load < 50 Copies/ml

All responders

Posted

Median

Inter-Quartile Range

days

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With Loss of Virologic Response Following Confirmed Virologic Response

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)

All treated patients; Too few patients had a loss of virologic response for a reasonable analysis of time to loss.

Posted

Number

Participants

baseline to week 24 and week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 2 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 2

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 4 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 4

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 6 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 6

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 8 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 8

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 12 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 12

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 24 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 24

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 36 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 36

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 50 Copies/ml at Week 48 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 2 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 2

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 4 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 4

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 6 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 6

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 8 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 8

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 12 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 12

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 24 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 24

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 36 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 36

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With HIV Viral Load < 400 Copies/ml at Week 48 of Treatment

Results within time windows, patients on-treatment

All treated patients

Posted

Number

Participants

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Patients With Virologic Rebound to >400 Copies/ml

HIV viral load >400 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)

All treated patients

Posted

Number

Participants

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

AIDS Progression and Death: Number of Patients With a Treatment-emergent AIDS Defining Illness or an AIDS-defining Illness Leading to Death

AIDS defining illnesses include: Aspergillosis, Bartonellosis, Candidiasis, Cervical cancer, Chagas disease, Coccidiodomycosis, Cryptococcosis, Cytomegalovirus retinus, encephalopathy, Herpes Simplex Virus, Histoplasmosis, Isosporiasis, Kaposi's sarcoma, Leishmaniasis, Microsporidiosis, Mycobacterium avium complex, mycobacterium (non-tuberculous), Nocardiosis, Pneumocystis carinii pneumonia, Pneumonia, Progressive Multifocal Leukoencephalopathy, Rhodococcus equi, Salmonella, Toxoplasmosis, Wasting.

Number of cases (no time-to analysis was performed due to small numbers).

All treated patients

Posted

Number

Participants

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants

Secondary

Change in CD4+ Cell Count From Baseline to Week 2.

Patients on-treatment, data within time windows

Includes only treated patients with data in the specified time window

Posted

Mean

Standard Deviation

cells/mm^3

baseline to week 2

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in CD4+ Cell Count From Baseline to Week 4.

Patients on-treatment, data within time windows

Includes only treated patients with data in the specified time window

Posted

Mean

Standard Deviation

cells/mm^3

baseline to week 4

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in CD4+ Cell Count From Baseline to Week 6.

Patients on-treatment, data within time windows

Includes only treated patients with data in the specified time window

Posted

Mean

Standard Deviation

cells/mm^3

baseline to week 6

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in CD4+ Cell Count From Baseline to Week 8.

Patients on-treatment, data within time windows

Includes only treated patients with data in the specified time window

Posted

Mean

Standard Deviation

cells/mm^3

baseline to week 8

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in CD4+ Cell Count From Baseline to Week 12.

Patients on-treatment, data within time windows

Includes only treated patients with data in the specified time window

Posted

Mean

Standard Deviation

cells/mm^3

baseline to week 12

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in CD4+ Cell Count From Baseline to Week 24.

Patients on-treatment, data within time windows

Includes only treated patients with data in the specified time window

Posted

Mean

Standard Deviation

cells/mm^3

baseline to week 24

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in CD4+ Cell Count From Baseline to Week 36.

Patients on-treatment, data within time windows

Includes only treated patients with data in the specified time window

Posted

Mean

Standard Deviation

cells/mm^3

baseline to week 36

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in CD4+ Cell Count From Baseline to Week 48.

Patients on-treatment, data within time windows

Includes only treated patients with data in the specified time window

Posted

Mean

Standard Deviation

cells/mm^3

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in Fasting Plasma Total Cholesterol Level

All treated patients with data, Last observation carried forward (LOCF).

Posted

Mean

Standard Deviation

mg/dl

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in Fasting Plasma Triglycerides Level

All treated patients with data, Last observation carried forward (LOCF)

Posted

Mean

Standard Deviation

mg/dl

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in Fasting High Density Lipoprotein (HDL) Cholesterol Level

All treated patients with data, Last observation carried forward (LOCF)

Posted

Mean

Standard Deviation

mg/dl

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in Fasting Low Density Lipoprotein (LDL)Cholesterol Level

All treated patients with data, Last observation carried forward (LOCF)

Posted

Mean

Standard Deviation

mg/dl

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in Fasting Total Cholesterol to High Density Lipoprotein (HDL) Ratio

All treated patients with data, Last observation carried forward (LOCF)

Posted

Mean

Standard Deviation

ratio

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in Framingham Score

Framingham prediction of 10-year risk of Coronary Heart Disease (CHD) outcomes (myocardial infarction [MI] or CHD death) based on the patient's gender, age, systolic blood pressure, total cholesterol, HDL-c and smoking status. The scale for the estimated risk ranges from 0 to 30%.

All treated patients with data, Last observation carried forward (LOCF)

Posted

Mean

Standard Deviation

percent 10-year risk

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in Revised Framingham Score According to the Data Collection on Adverse Events of Anti-HIV Drugs (DAD) Study Group

Not calculated as no data on family history of cardiovascular disease were available

Posted

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Change in Glomerular Filtration Rate (GFR) From Baseline to Week 48

using 4-variable Modification of Diet in Renal Disease (MDRD) formula

Includes only treated patients with data for the specified time window

Posted

Mean

Standard Deviation

ml/min/1.73m^2

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Percentage Adherence by Pill Count

Number of pills not returned / number of treatment days in percent (%)

All treated patients with data

Posted

Mean

Standard Deviation

percentage adherence

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Number of Participants With Genotypic Resistance at the Time of Virologic Failure.

Genotypic resistance was measured by the following: Plasma samples for HIV-1 resistance were analyzed using a standard clinical assay that generates a virtual phenotypic interpretation of HIV-1 sequence data and predicts susceptibility or resistance of the isolate to approved ARVs. This analysis has not been performed.

Includes only treated patients with data in the specified time window

Posted

baseline to week 48

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Incidence of Patients With AIDS Progression at Each Visit

Cumulative incidence of patients with AIDS progression are shown

Full Analysis set

Posted

Number

participants

baseline to week 52

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Proportion of Patients Reporting CNS Side Effects of Any Severity

All treated patients

Posted

Number

participants

baseline to week 52

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Proportion of Patients Reporting Hepatic Events of Any Severity

All treated patients

Posted

Number

participants

baseline to week 52

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Proportion of Patients Reporting Rash of Any Severity

All treated patients

Posted

Number

participants

baseline to week 52

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Secondary

Proportion of Patients With DAIDS Grade >= 2 Laboratory Abnormalities

All treated patients

Posted

Number

participants

baseline to week 52

ID	Title	Description
OG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
OG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchopneumonia	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Cerebral toxoplasmosis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Burkitt's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0011 affected77 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Immune reconstitution syndrome	Immune system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0011 affected77 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0012 affected77 at risk
Suicide attempt	Psychiatric disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0012 affected77 at risk
Completed suicide	Psychiatric disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Depression	Psychiatric disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0011 affected77 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0011 affected77 at risk
Mononeuropathy multiplex	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Dizziness	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Pericardial effusion	Cardiac disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0011 affected77 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0011 affected77 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0011 affected77 at risk
Hepatitis	Hepatobiliary disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Transaminases increased	Investigations	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0011 affected77 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0011 affected77 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0010 affected77 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0011 affected77 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0011 affected77 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0008 affected75 at risk EG00118 affected77 at risk
Sinusitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0003 affected75 at risk EG0017 affected77 at risk
Anogenital warts	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0016 affected77 at risk
Bronchitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0002 affected75 at risk EG0015 affected77 at risk
Insomnia	Psychiatric disorders	MedDRA (13.0)	Systematic Assessment	EG0004 affected75 at risk EG0017 affected77 at risk
Headache	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG00011 affected75 at risk EG00111 affected77 at risk
Dizziness	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0004 affected75 at risk EG0015 affected77 at risk
Ocular icterus	Eye disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG00111 affected77 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0007 affected75 at risk EG0018 affected77 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Systematic Assessment	EG0005 affected75 at risk EG0011 affected77 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00012 affected75 at risk EG00115 affected77 at risk
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG00010 affected75 at risk EG00111 affected77 at risk
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0003 affected75 at risk EG0016 affected77 at risk
Gastritis	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG0014 affected77 at risk
Jaundice	Hepatobiliary disorders	MedDRA (13.0)	Systematic Assessment	EG0000 affected75 at risk EG00112 affected77 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0007 affected75 at risk EG0013 affected77 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0001 affected75 at risk EG0016 affected77 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Systematic Assessment	EG0006 affected75 at risk EG0013 affected77 at risk
Fatigue	General disorders	MedDRA (13.0)	Systematic Assessment	EG00013 affected75 at risk EG00110 affected77 at risk
Oedema peripheral	General disorders	MedDRA (13.0)	Systematic Assessment	EG0002 affected75 at risk EG0014 affected77 at risk

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D000068698	Tenofovir
D000068679	Emtricitabine
D019829	Nevirapine
C494814	BID protein, human
D000069446	Atazanavir Sulfate
D019438	Ritonavir

ID	Term
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000225	Adenine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D011725	Pyridines
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D013844	Thiazoles
D013457	Sulfur Compounds
D001393	Azoles

ID	Title	Description
BG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)
BG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Nevirapine (NVP) Plus Truvada	Nevirapine 200 mg bis in die (BID)			10	75	50	75
EG001	Atazanavir Plus Ritonavir (ATV/r) Plus Truvada	Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)			7	77	61	77