Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects (TRU)

This study has been completed.

Sponsor:

Collaborator:

Gilead Sciences

Information provided by (Responsible Party):

St. Luke's-Roosevelt Hospital Center

ClinicalTrials.gov Identifier:

NCT00960622

First received: August 17, 2009

Last updated: January 25, 2013

Last verified: September 2012

History of Changes

Results First Received: September 21, 2011

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

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
Subjects were recruited from clinics.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects had to take combivir or trizivir for at least 6 months prior to enrollment

Reporting Groups

	Description
Truvada 200/300 mg, Daily, by Mouth.	The study subjects will be randomly assigned to switch from Combivir or from trizivir to open-label Truvada.
Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.	The study subjects will be randomly assigned to continue on Combivir or trizivir.This will serve as comparator group.

Participant Flow: Overall Study

	Truvada 200/300 mg, Daily, by Mouth.	Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.
STARTED	10	10
COMPLETED	10	7
NOT COMPLETED	0	3

Baseline Characteristics

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Reporting Groups

	Description
Truvada	switch from Combivir to Truvada
Combivir, Trizivir.	continue on Combivir, trizivir.
Total	Total of all reporting groups

Baseline Measures

	Truvada	Combivir, Trizivir.	Total
Number of Participants [units: participants]	10	10	20
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	10	10	20
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	52 ± 6	53 ± 4	53 ± 7
Gender [units: participants]
Female	1	1	2
Male	9	9	18
Region of Enrollment [units: participants]
United States	10	10	20

Outcome Measures

1. Primary:

Change in Peak Oxygen Uptake. [ Time Frame: baseline and 6 months ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	1 year
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	1%

Reporting Groups

	Description
Truvada	switch from Combivir to Truvada
Combivir, Trizivir.	continue on Combivir, trizivir.

Other Adverse Events

	Truvada	Combivir, Trizivir.
Total, other (not including serious) adverse events
# participants affected / at risk	0/0	0/0

More Information

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Certain Agreements:

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

There is NOT 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.

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
No text entered.

Results Point of Contact:

Name/Title: Dr. Donald Phillip Kotler
Organization: St Luke's Roosevelt Hospital New York
phone: 212 523 3670
e-mail: dkotler@chpnet.org

No publications provided

Responsible Party:	St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:	NCT00960622 History of Changes
Other Study ID Numbers:	TRU
Study First Received:	August 17, 2009
Results First Received:	September 21, 2011
Last Updated:	January 25, 2013
Health Authority:	United States: Food and Drug Administration

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