Changes in Triglyceride and Other Lipids (Levels of Fats Found in Blood) When Taking Darunavir Compared to Atazanavir in HIV-infected Patients That Have Never Received Treatment

This study has been completed.

Sponsor:

Collaborator:

Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Information provided by:

Tibotec, Inc

ClinicalTrials.gov Identifier:

NCT00757783

First received: September 19, 2008

Last updated: August 17, 2012

Last verified: August 2012

History of Changes

Results First Received: August 12, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV
Interventions:	Drug: ritonavir Drug: darunavir Drug: emtricitabine [FTC]/tenofovir [TDF] Drug: atazanavir

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This is a phase 4, multicenter, open-label, randomized study (TMC114HIV4023). The study will be conducted at approximately 16 study sites in the United States. Approximately 60 HIV-1 infected, treatment-naive adult subjects will be enrolled in the study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Darunavir	darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Participant Flow: Overall Study

	Darunavir	Atazanavir
STARTED	34	31
COMPLETED	32	30
NOT COMPLETED	2	1
Lost to Follow-up	1	0
Withdrawal by Subject	1	0
Other	0	1

Baseline Characteristics

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Reporting Groups

	Description
Darunavir	darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Total	Total of all reporting groups

Baseline Measures

	Darunavir	Atazanavir	Total
Number of Participants [units: participants]	34	31	65
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	34	30	64
>=65 years	0	1	1
Age [units: years] Mean ± Standard Deviation	35.9 ± 10.35	36.9 ± 11.66	36.4 ± 10.92
Gender [units: participants]
Female	5	4	9
Male	29	27	56
Region of Enrollment [units: participants]
US	34	31	65
log HIV-1 RNA [units: copies/mL] Mean ± Standard Deviation	5.016 ± 0.7846	4.562 ± 0.6535	4.800 ± 0.7549

Outcome Measures

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1. Primary:

Change From Baseline in Fasting Triglyceride (TG) Levels in the Lipid Evaluable (LE) Set at Week 12. [ Time Frame: Baseline, Week 12 ]

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2. Secondary:

Change From Baseline in Total Cholesterol (TC) Levels in the LE Set at Week 12. [ Time Frame: Baseline, Week 12 ]

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3. Secondary:

Change From Baseline in Low Density Lipoprotein (LDL) Direct in the LE Set at Week 12. [ Time Frame: Baseline, Week 12 ]

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4. Secondary:

Change From Baseline in High Density Lipoprotein (HDL) in the LE Set at Week 12. [ Time Frame: Baseline, Week 12 ]

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5. Secondary:

Change From Baseline in Apolipoprotein A1 in the LE Set at Week 12. [ Time Frame: Baseline, Week 12 ]

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6. Secondary:

Change From Baseline in Apolipoprotein B in the LE Set at Week 12. [ Time Frame: Baseline, Week 12 ]

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7. Secondary:

Change From Baseline in TC/HDL Ratio in the LE Set at Week 12. [ Time Frame: Baseline, Week 12 ]

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Measure Type	Secondary
Measure Title	Change From Baseline in TC/HDL Ratio in the LE Set at Week 12.
Measure Description	Observed Values
Time Frame	Baseline, Week 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The LE set consisted of all subjects in the PP analysis set who remained on study through Week 12 and had a fasting lipid assessment at baseline and at least once post first dose of DRV or ATV prior to or on the Week 12 visit.

Reporting Groups

	Description
Darunavir	darunavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 800 mg tablet once daily for 48 weeks;200/300 mg tablet once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks
Atazanavir	atazanavir;emtricitabine [FTC]/tenofovir [TDF];ritonavir. 300 mg capsule once daily for 48 weeks;200/300 mg once daily for 48 weeks;100 mg capsule or tablet once daily for 48 weeks

Measured Values

	Darunavir	Atazanavir
Number of Participants Analyzed [units: participants]	27	27
Change From Baseline in TC/HDL Ratio in the LE Set at Week 12. [units: Ratio] Mean ± Standard Deviation	-0.09 ± 0.907	-0.15 ± 0.665

No statistical analysis provided for Change From Baseline in TC/HDL Ratio in the LE Set at Week 12.

8. Secondary:

Change From Baseline in Glucose at Week 12. [ Time Frame: Baseline, Week 12 ]

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9. Secondary:

Change From Baseline in Insulin at Week 12. [ Time Frame: Baseline, Week 12 ]

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10. Secondary:

Change From Baseline in Homeostasis Model Assessment–Insulin Resistance (HOMA-IR) at Week 12. [ Time Frame: Baseline, Week 12 ]

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11. Secondary:

Antiviral Activity, Human Immunodeficiency Virus Type 1 (HIV-1) RNA. [ Time Frame: Baseline, Week 12 ]

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12. Secondary:

Antiviral Activity, HIV-1 RNA, Missing Values as Treatment Failure (M=F) [ Time Frame: Baseline, Week 12 ]

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13. Secondary:

Change From Baseline in HIV-1 RNA Viral Load at Week 12. [ Time Frame: Baseline, Week 12 ]

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14. Secondary:

Change From Baseline in CD4 Cell Count at Week 12. [ Time Frame: Baseline, Week 12 ]

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15. Secondary:

Change From Baseline in CD4 Cell Count at Week 12, Last Observation Carried Forward (LOCF). [ Time Frame: Baseline, Week 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If TTCA does not publish within 12 months after study conclusion or after TTCA confirms there will be no multicenter publication, Institution may publish their results from their site individually, provided TTCA has 60 day review for confidentiality and additional 60 day delay for patent application.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
65 subjects were enrolled/treated in the main study. 3 subjects were enrolled, randomized, not treated and excluded from analyses (n=68). An additional 18 subjects were enrolled in a substudy extension and excluded from the main analyses.

Results Point of Contact:

Name/Title: Vice President, Tibotec Therapeutics Clinical Affairs
Organization: Tibotec Therapeutics Clinical Affairs (TTCA), Division of Centocor Ortho Biotech Services, LLC
phone: 877-732-2488

No publications provided by Tibotec, Inc

Publications automatically indexed to this study:

Gupta SK, Mi D, Liu Z, Saha C. Endothelial, inflammatory, coagulation, metabolic effects and safety of etravirine in HIV-uninfected volunteers. AIDS Patient Care STDS. 2011 Jun;25(6):327-31. Epub 2011 Apr 6.

Responsible Party:	Vice President, Clinical Affairs, Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
ClinicalTrials.gov Identifier:	NCT00757783 History of Changes
Other Study ID Numbers:	CR015439, TMC114HIV4023
Study First Received:	September 19, 2008
Results First Received:	August 12, 2010
Last Updated:	August 17, 2012
Health Authority:	United States: Food and Drug Administration

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