TOTEM: Switch From Other Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to Once Daily Truvada

This study has been completed.

Study NCT00323492 Information provided by Gilead Sciences

First Received on May 5, 2006. Last Updated on January 13, 2010 History of Changes

Results First Received: March 20, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	HIV Infections
Interventions:	Drug: Truvada Drug: Current HAART regimen

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
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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
Truvada	Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
Maintain Baseline Regimen	Maintain baseline regimen.
Delayed Truvada	Truvada + NNRTI or PI (participants from the control group who switched NRTIs to Truvada during Study Phase 2).

Participant Flow for 2 periods

Period 1: Study Phase 1

	Truvada	Maintain Baseline Regimen	Delayed Truvada
STARTED	47	45	0 ^[1]
Intent-to-Treat (ITT) Analysis Set	46 ^[2]	45	0
COMPLETED	45	45	0
NOT COMPLETED	2	0	0
Adverse Event	2	0	0

[1]	Not applicable to Phase 1.
[2]	One subject was excluded from ITT analysis set due to protocol violation.

Period 2: Study Phase 2

	Truvada	Maintain Baseline Regimen	Delayed Truvada
STARTED	44 ^[1]	18 ^[2]	25 ^[3]
COMPLETED	40	17	24
NOT COMPLETED	4	1	1
Adverse Event	1	0	0
Physician Decision	1	0	0
Lost to Follow-up	1	0	0
Withdrawal by Subject	0	1	0
Noncompliance with study schedule	0	0	1
Protocol Violation	1	0	0

[1]	1/45 subjects completed Phase 1 but did not start Phase 2. Week 48 ITT N=46
[2]	2/45 subjects completed Phase 1 but did not start Phase 2. Week 48 ITT N=20 (no switch to Truvada)
[3]	N=25 switched to Truvada in Phase 2.

Baseline Characteristics

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Reporting Groups

	Description
Truvada	Truvada + NNRTI or PI.
Maintain Baseline Regimen	Maintain baseline regimen.

Baseline Measures

	Truvada	Maintain Baseline Regimen	Total
Number of Participants [units: participants]	47	45	92
Age [units: years] Median ( Inter-Quartile Range )	49.0 ( 42.0 to 58.0 )	43.0 ( 39.0 to 50.0 )	47.0 ( 41.0 to 55.0 )
Gender [units: participants]
Female	8	4	12
Male	39	41	80
Region of Enrollment [units: participants]
France	47	45	92
Participants with plasma HIV-1 RNA < 400 copies/mL ^[1] [units: participants]	47	45	92
Cluster determinant 4 (CD4) cell count ^[1] [units: cells/mm^3] Median ( Inter-Quartile Range )	467 ( 314 to 698 )	559 ( 337 to 714 )	528 ( 318 to 709 )
Low density lipoprotein cholesterol (LDL-CHO) ^[2] [units: mmol/L] Median ( Inter-Quartile Range )	4.0 ( 3.2 to 4.7 )	4.0 ( 3.6 to 4.8 )	4.0 ( 3.4 to 4.7 )
Triglycerides ^[2] [units: mmol/L] Median ( Inter-Quartile Range )	2.3 ( 1.9 to 4.0 )	2.7 ( 1.9 to 3.6 )	2.4 ( 1.9 to 3.7 )

[1]	At screening
[2]	Centralized laboratory assessment

Outcome Measures

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1. Primary:

Change From Baseline to Week 12 in Fasting Triglycerides [ Time Frame: Baseline to Week 12 ]

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2. Primary:

Change From Baseline to Week 12 in Fasting Low-density Lipoprotein Cholesterol (LDL-CHO) [ Time Frame: Baseline to Week 12 ]

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3. Secondary:

Change From Baseline to Week 12 in Fasting High-density Lipoprotein Cholesterol (HDL-CHO) [ Time Frame: Baseline to Week 12 ]

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4. Secondary:

Change From Baseline to Week 12 in Fasting Total Cholesterol (T-CHO) [ Time Frame: Baseline to Week 12 ]

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5. Secondary:

Change From Baseline to Week 12 in Fasting T-CHO/HDL-CHO [ Time Frame: Baseline to Week 12 ]

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6. Secondary:

Change From Baseline to Week 12 in Fasting HDL-CHO/LDL-CHO [ Time Frame: Baseline to Week 12 ]

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7. Secondary:

Change From Baseline to Week 12 in Fasting Ultra-sensitive C-reactive Protein (Us-CRP) [ Time Frame: Baseline to Week 12 ]

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8. Secondary:

Percentage of Participants With Fasting Plasma Triglycerides > 10 g/L (> 11.29 mmol/L) at Week 12 [ Time Frame: 12 weeks ]

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9. Secondary:

Change From Baseline to Week 12 in Cluster Determinant 4 (CD4) Cell Count [ Time Frame: Baseline to Week 12 ]

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10. Secondary:

Change From Baseline to Week 48 in CD4 Cell Count [ Time Frame: Baseline to Week 48 ]

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11. Secondary:

Percentage of Participants With Virologic Control (Plasma HIV-1 Ribonucleic Acid [RNA] < 400 Copies/mL) at Week 12 [ Time Frame: 12 weeks ]

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12. Secondary:

Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to 400 Copies/mL at Week 12 [ Time Frame: 12 weeks ]

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13. Secondary:

Percentage of Participants With Plasma HIV-1 RNA < 400 Copies/mL at Week 48 [ Time Frame: 48 weeks ]

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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: After conclusion of the study and without prior written approval from Gilead Sciences, investigators in this study may communicate, orally present, or publish in scientific journals or other scholarly media only after the following conditions have been met: results of the study in their entirety have been publicly disclosed by or with the consent of Gilead Sciences in an abstract, manuscript, or presentation form; or study has been completed at all study sites for at least 2 years.

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
Comparison of adverse events between Truvada and maintain baseline regimen groups is inappropriate since numbers at risk (and exposure to study drug) are not balanced, as described in the adverse event treatment group descriptions.

Results Point of Contact:

Name/Title: Camille Aubron-Olivier
Organization: Gilead Sciences
phone: +33(0)1 42 737130
e-mail: camille.aubron-olivier@gilead.com

No publications provided

Responsible Party:	Camille Aubron-Olivier, Gilead Sciences
ClinicalTrials.gov Identifier:	NCT00323492 History of Changes
Other Study ID Numbers:	GS-FR-164-0109
Study First Received:	May 5, 2006
Results First Received:	March 20, 2009
Last Updated:	January 13, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency