Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

This study has been completed.

Sponsor:

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Robert Dicenzo, University of Rochester

ClinicalTrials.gov Identifier:

NCT00745368

First received: September 1, 2008

Last updated: September 7, 2012

Last verified: September 2012

History of Changes

Results First Received: July 25, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label
Condition:	HIV Infections
Intervention:	Drug: Raltegravir

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
Raltegravir	Raltegravir 400 mg tablets twice daily

Participant Flow: Overall Study

	Raltegravir
STARTED	19 ^[1]
COMPLETED	16 ^[2]
NOT COMPLETED	3
Unable to provide sample	3

[1]	Of the 28 subjects who enrolled, 19 participated in a study visit
[2]	3 male subjects were unable to provide a sample and are not included in the results

Baseline Characteristics

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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.
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Reporting Groups

	Description
Raltegravir	Raltegravir 400 mg tablets twice daily

Baseline Measures

	Raltegravir
Number of Participants [units: participants]	16
Age [units: participants]
<=18 years	0
Between 18 and 65 years	16
>=65 years	0
Age [units: years] Mean (Standard Deviation)	47 (8.8)
Gender [units: participants]
Female	8
Male	8
Region of Enrollment [units: participants]
United States	16

Outcome Measures

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1. Primary:

Raltegravir Male Genital Tract Concentration [ Time Frame: 8-10 hours after raltegravir dose ]

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Measure Type	Primary
Measure Title	Raltegravir Male Genital Tract Concentration
Measure Description	No text entered.
Time Frame	8-10 hours after raltegravir dose
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.
No text entered.

Reporting Groups

	Description
Raltegravir	Raltegravir 400 mg tablets twice daily

Measured Values

	Raltegravir
Number of Participants Analyzed [units: participants]	8
Raltegravir Male Genital Tract Concentration [units: ng/mL] Median (Inter-Quartile Range)	485.1 (428.5 to 753.3)

No statistical analysis provided for Raltegravir Male Genital Tract Concentration

2. Primary:

Raltegravir Female Genital Tract Concentration [ Time Frame: 8-10 hours after raltegravir dose ]

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3. Primary:

Male Paired Plasma Concentration [ Time Frame: 8-10 hours after raltegravir dose ]

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4. Primary:

Female Paired Plasma Concentration [ Time Frame: 8-10 hours after raltegravir dose ]

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5. Primary:

Male Time Since Last Dose [ Time Frame: 8-10 hours after raltegravir dose ]

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6. Primary:

Female Time Since Last Dose [ Time Frame: 8-10 hours after raltegravir dose ]

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7. Primary:

Male Genital Tract:Plasma Concentration Ratio [ Time Frame: 8-10 hours after raltegravir dose ]

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8. Primary:

Female Genital Tract:Plasma Concentration Ratio [ Time Frame: 8-10 hours after raltegravir dose ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
Due to limited sample size and large intersubject variability, more study comparing male and female GT concentrations is needed.

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.

Results Point of Contact:

Name/Title: Robert DiCenzo
Organization: University of Rochester
phone: 518 694 7228
e-mail: rob.dicenzo@acphs.edu

Responsible Party:	Robert Dicenzo, University of Rochester
ClinicalTrials.gov Identifier:	NCT00745368 History of Changes
Other Study ID Numbers:	33113
Study First Received:	September 1, 2008
Results First Received:	July 25, 2012
Last Updated:	September 7, 2012
Health Authority:	United States: Institutional Review Board

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