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

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

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

1.  Primary:

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

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 ]

3.  Secondary:

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

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 ]

5.  Secondary:

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

6.  Secondary:

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

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 ]

8.  Secondary:

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

9.  Secondary:

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

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 ]

11.  Secondary:

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

Time Frame	No text entered.
Additional Description	No text entered.

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)

Serious Adverse Events

	FPV/r100	FPV/r200
Total, Serious Adverse Events
# participants affected	7	1
Cardiac disorders
Cardiac failure congestive † 1
# participants affected / at risk	1/142 (0.70%)	0/67 (0.00%)
Gastrointestinal disorders
Pancreatitis chronic † 1
# participants affected / at risk	1/142 (0.70%)	0/67 (0.00%)
Peptic ulcer † 1
# participants affected / at risk	1/142 (0.70%)	0/67 (0.00%)
General disorders
Chest pain † 1
# participants affected / at risk	0/142 (0.00%)	1/67 (1.49%)
Infections and infestations
Appendicitis † 1
# participants affected / at risk	1/142 (0.70%)	0/67 (0.00%)
Cellulitis † 1
# participants affected / at risk	1/142 (0.70%)	0/67 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm † 1
# participants affected / at risk	1/142 (0.70%)	0/67 (0.00%)
Nervous system disorders
Central nervous system lesion † 2
# participants affected / at risk	1/142 (0.70%)	0/67 (0.00%)
Cerebrovascular accident † 1
# participants affected / at risk	1/142 (0.70%)	0/67 (0.00%)

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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