Expired Study
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Washington, District of Columbia 20007


Purpose:

The hope of this study is to gather data and information about the tolerability and effectiveness of Lexiva versus Sustiva in patients who have have been generally underrepresented in clinical trials.


Study summary:

The objective of this study is to gain tolerability and efficacy data for Norvir-boosted Lexiva versus Sustiva, both used in combination with Epzicom, as components of a first-line, once daily regimen for the treatment of HIV-1 infection in a patient population that is underrepresented in US clinical research.


Criteria:

Inclusion Criteria: Screening plasma HIV-1 RNA viral load >5000 copies/mL Self-identification as having any non-White/Caucasian European geographic ancestry (i.e., an individual is eligible if she/he does not have any White/Caucasian European ancestry; OR an individual is eligible if she/he indicates a mix of White/Caucasian European ancestry AND one or more other geographic ancestries); Antiretroviral-naïve (no treatment with any antiretroviral drug in the 28 days prior to study entry and ≤14 days of treatment ever with any antiretroviral drug) Negative test for the HLA-B*5701 allele Ability and willingness to give written informed consent Either gender is eligible, but enrollment of at least two female subjects to every one male subject is strongly encouraged. A female subject is eligible to participate in the study if she is of: 1. Non-childbearing potential or, 2. Childbearing potential with a negative pregnancy test at screen and agrees to use one of the following methods of contraception: i. Agreement for complete abstinence from intercourse from 2 weeks prior to administration of investigational products, throughout the study, and for 2 weeks after discontinuation of all study medications; ii. Double barrier contraception (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); iii. Any intrauterine device (IUD) with published data showing that the expected failure rate is less than 1% per year (not all IUDs meet this criterion); iv. Any other method with published data showing that the lowest expected failure rate for the method is less than 1% per year. v. Sterilization (female subject or male partner of female subject) Exclusion Criteria: Screening HIV-1 genotype indicating the presence of any of the following mutations in the reverse transcriptase (RT) region: K65R, L74V, K103N, Y115F, Y181C/I, Y188C/L/H or G190S/A, or a combination of two or more thymidine analog mutations (M41L, D67N, K70R, K219Q or E) that include changes at either L210 or T215, associated with resistance to abacavir, lamivudine, or efavirenz; OR within the protease region, detection of any of the following mutations associated with resistance to fosamprenavir or ritonavir: I50V, I54L/M, I84V, or the combination of the two mutations V32I+I147V Positive for Hepatitis B surface antigen (HBsAg+) Requirement for active treatment for hepatitis C virus infection, as indicated by both a positive Hepatitis C Virus serology AND either: 1. Decompensated liver disease, or 2. Aspartate aminotransferase (AST) >3X the upper limit of normal (ULN), or 3. Alanine aminotransferase (ALT) >3X the ULN Currently pregnant, intending to become pregnant during the study period, or breast-feeding Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), any vaccinations, systemic cytotoxic chemotherapy, or investigational therapy within 28 days prior to study entry. Chronic treatment with prednisone at a daily dose of 10 mg or less is permitted. Acute treatment (less than 21 days) with larger doses of corticosteroids for acute therapy is permitted. Active or suspected drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements Judged by the investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results Active or acute Centers for Disease Control Clinical Category C event at screening. (Note: Treatment for the acute event must have been completed at least 28 days prior to screening.) Clinically relevant pancreatitis or clinically relevant hepatitis at screening Hgb<8g/dl, platelet count <50,000/mm3, calculated creatinine clearance <50ml/min via Cockroft-Gault equation, or AST or ALT > 5X the ULN Any Grade 4 laboratory abnormality


Study is Available At:


Original ID:

COL 110408


NCT ID:

NCT00727597


Secondary ID:


Study Acronym:

SUPPoRT


Brief Title:

A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT


Official Title:

A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Georgetown University


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

101


Enrollment Type:

Actual


Overall Contact Information

Official Name:Princy Kumar, MD
Principal Investigator
Georgetown University

Study Dates

Start Date:July 2008
Completion Date:July 2011
Completion Type:Actual
Primary Completion Date:August 2010
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 28, 2013
First Received Date:July 31, 2008
First Results Date:August 28, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events
Time Frame:96 weeks
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)
Time Frame:96 weeks
Safety Issues:True
Description: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 fail

Study Interventions

Intervention Type:Drug
Name:Efavirenz 600mg
Description:QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg) The intervention may be switched for the following 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
Arm Name:Arm B: Efavirenz plus Epzicom
Other Name:Efavirenz(Sustiva)600 mg
Intervention Type:Drug
Name:Boosted Lexiva
Description:Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg) The intervention may be switched for the following 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 complia
Arm Name:Arm A : Boosted Lexiva plus Epzicom
Other Name:Fosamprenavir(Lexiva)

Study Arms

Study Arm Type:Experimental
Arm Name:Arm B: Efavirenz plus Epzicom
Description:QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
Study Arm Type:Experimental
Arm Name:Arm A : Boosted Lexiva plus Epzicom
Description:Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Georgetown University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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