A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00363142

First received: August 11, 2006

Last updated: October 21, 2010

Last verified: October 2010

History of Changes

Results First Received: June 11, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	HIV Infection Infection, Human Immunodeficiency Virus
Interventions:	Drug: Half-boosted Fosamprenavir Drug: Full Boosted Fosamprenavir

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
Participants were stratified prior to randomization according to baseline regimen (700 milligrams [mg]/100 mg twice a day [BID] or 1400 mg/200 mg once a day [QD]) and previous regimen (no other prior protease inhibitor [PI], non-boosted PI, or boosted PI). Results are reported for the 209 participants (out of 211 enrolled) receiving study drug.

Reporting Groups

	Description
FPV/r100	Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
FPV/r200	FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)

Participant Flow: Overall Study

	FPV/r100	FPV/r200
STARTED	140	69
COMPLETED	133	66
NOT COMPLETED	7	3
Adverse Event	2	0
Lack of Efficacy	0	1
Lost to Follow-up	1	0
Non-compliance	1	1
Withdrawal by Subject	3	1

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
FPV/r100	Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
FPV/r200	FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
Total	Total of all reporting groups

Baseline Measures

	FPV/r100	FPV/r200	Total
Overall Participants Analyzed [Units: Participants]	140	69	209

Age [Units: Years] Mean (Standard Deviation)	44.9 (10.52)	44.3 (8.9)	44.7 (10.00)

Gender [Units: Participants]
Female	33	9	42
Male	107	60	167

Race/Ethnicity, Customized [Units: Participants]
African American/African heritage	42	20	62
American Indian/Alaskan native	1	0	1
Asian - South East Asian	0	2	2
Native Hawaiian or Other Pacific Islander	0	1	1
White - Arabic/North African	0	2	2
White - White/Caucasian/European	95	44	139
Mixed race	1	0	1
Other	1	0	1

Ethnicity (NIH/OMB) [Units: Participants]
Hispanic or Latino	31	11	42
Not Hispanic or Latino	109	58	167
Unknown or Not Reported	0	0	0

Outcome Measures

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1. Primary:

Percentage of Participants Not Meeting the Definition of Virologic Failure at or Prior to Week 24 [ Time Frame: Week 24 ]

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2. Secondary:

Percentage of Participants With Plasma Human Immunodeficiency Virus, Type 1, Ribonucleic Acid (HIV-1 RNA) <400 Copies/mL at Week 24, Time to Loss of Virologic Response (TLOVR) Analysis [ Time Frame: Week 24 ]

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3. Secondary:

Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 24, TLOVR Analysis [ Time Frame: Week 24 ]

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4. Secondary:

Mean Change From Baseline of log10 Copies/mL Plasma HIV-1 RNA Levels at Week 24, Observed Analysis [ Time Frame: Baseline and Week 24 ]

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5. Secondary:

Median Change From Baseline of CD4+ Cell Count at Week 24, Observed Analysis [ Time Frame: Baseline and Week 24 ]

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6. Secondary:

Number of Participants Who Discontinued Treatment Due to Adverse Events Through Week 24 [ Time Frame: Baseline through Week 24 ]

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7. Secondary:

Number of Participants With Grade 2-4 Adverse Events Occurring in Greater Than or Equal to 2% of Subjects Through Week 24 [ Time Frame: Baseline through Week 24 ]

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8. Secondary:

Percent Change From Baseline in Total Cholesterol, High Density Lipoprotein (HDL), and Triglycerides at Week 24 [ Time Frame: Baseline and Week 24 ]

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9. Secondary:

Percent Change From Baseline in Low Density Lipoprotein (LDL) at Week 24 [ Time Frame: Baseline and Week 24 ]

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10. Secondary:

Number of Participants With Plasma HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline [ Time Frame: Baseline through Week 24 ]

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11. Secondary:

Steady-State Plasma Levels of Amprenavir (APV) and Ritonavir (RTV) Ctau at Weeks 12 and 24 [ Time Frame: Weeks 12 and 24 ]

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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
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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: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cohen C, Dejesus E, Lamarca A, Young B, Yau L, Patel L, Vavro C, Wire MB, Wannamaker P, Shaefer M. Similar virologic and immunologic efficacy with fosamprenavir boosted with 100 mg or 200 mg of ritonavir in HIV-infected patients: results of the LESS trial. HIV Clin Trials. 2010 Sep-Oct;11(5):239-47. doi: 10.1310/hct1105-239.

Responsible Party:	E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00363142 History of Changes
Other Study ID Numbers:	LEX106430
Study First Received:	August 11, 2006
Results First Received:	June 11, 2009
Last Updated:	October 21, 2010

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