Trial Outcomes & Findings for A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT (NCT NCT00727597)

Results Overview

Subjects were randomized and initiated treatment on one of the antiretroviral arms(FPV/r or EFV) at study Entry visit. Subjects would be switched for the follwing reasons: * To resolve a Grade 3 or 4 Adverse Event * The subject experienced a virologic failure (as defined in section 3.6.2) * The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue * The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

101 participants

Primary outcome timeframe

96 weeks

Results posted on

2013-07-02

Participant Flow

Patients ≥18 years of age who were ART-naïve (≤14 days of treatment with any ART agent), HLA-B\*5701-negative, and had a screening HIV-1 RNA \>5000 copies/mL. Patients were required to be of minority race or ethnicity; white, non-Hispanic patients were not eligible for this study.

Participant milestones

Participant milestones
Measure	Once Daily (QD) Regimen of Lexiva Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).	QD Regimen of Sustiva QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
Overall Study STARTED	51	50
Overall Study COMPLETED	51	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Once Daily (QD) Regimen of Lexiva n=51 Participants Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).	QD Regimen of Sustiva n=50 Participants QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=99 Participants	50 Participants n=107 Participants	100 Participants n=206 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Age Continuous	33.5 years STANDARD_DEVIATION 2 • n=99 Participants	34 years STANDARD_DEVIATION 2 • n=107 Participants	34 years STANDARD_DEVIATION 2 • n=206 Participants
Sex: Female, Male Female	16 Participants n=99 Participants	16 Participants n=107 Participants	32 Participants n=206 Participants
Sex: Female, Male Male	35 Participants n=99 Participants	34 Participants n=107 Participants	69 Participants n=206 Participants
Region of Enrollment United States	51 participants n=99 Participants	50 participants n=107 Participants	101 participants n=206 Participants

PRIMARY outcome

Timeframe: 96 weeks

Subjects were randomized and initiated treatment on one of the antiretroviral arms(FPV/r or EFV) at study Entry visit. Subjects would be switched for the follwing reasons: * To resolve a Grade 3 or 4 Adverse Event * The subject experienced a virologic failure (as defined in section 3.6.2) * The investigator believes the subject is at a significant risk for failing to comply with the protocol AND the investigator believes a regimen substitution is likely to resolve the compliance issue * The investigator believes there is any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)

Outcome measures

Outcome measures
Measure	Once Daily (QD) Regimen of Lexiva n=51 Participants Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).	QD Regimen of Sustiva n=50 Participants QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)	1 participants	2 participants

PRIMARY outcome

Timeframe: 96 weeks

Outcome measures

Outcome measures
Measure	Once Daily (QD) Regimen of Lexiva n=51 Participants Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).	QD Regimen of Sustiva n=50 Participants QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events	2 participants	3 participants

Adverse Events

Once Daily (QD) Regimen of Lexiva

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

QD Regimen of Sustiva

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Once Daily (QD) Regimen of Lexiva n=51 participants at risk Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).	QD Regimen of Sustiva n=50 participants at risk QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
Cardiac disorders Cardiac Arrest	2.0% 1/51 • Number of events 1	0.00% 0/50
Immune system disorders Suspected Drug Hypersensitivity to ABC	2.0% 1/51 • Number of events 1	2.0% 1/50 • Number of events 1
Endocrine disorders Acute Pancreatitis	0.00% 0/51	2.0% 1/50 • Number of events 1

Other adverse events

Other adverse events
Measure	Once Daily (QD) Regimen of Lexiva n=51 participants at risk Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).	QD Regimen of Sustiva n=50 participants at risk QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
General disorders cholesterol, total neutrophils, creatine kinase, and triglycerides	17.6% 9/51 • Number of events 9	30.0% 15/50 • Number of events 15

Additional Information

Dr. Princy Kumar

Georegtown University

Phone: 2024440086

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place