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A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT (SUPPoRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00727597
Recruitment Status : Completed
First Posted : August 4, 2008
Results First Posted : July 2, 2013
Last Update Posted : July 2, 2013
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Princy Kumar, MD, Georgetown University

Tracking Information
First Submitted Date  ICMJE July 31, 2008
First Posted Date  ICMJE August 4, 2008
Results First Submitted Date  ICMJE August 28, 2012
Results First Posted Date  ICMJE July 2, 2013
Last Update Posted Date July 2, 2013
Study Start Date  ICMJE July 2008
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2013)
  • Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV) [ Time Frame: 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)
  • Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events [ Time Frame: 96 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2008)
To evaluate the tolerability of once-daily Lexiva boosted with 100 mg Norvir compared with once-daily Sustiva, both when used in combination with Epzicom, in a population that is often underrepresented in clinical trials. [ Time Frame: 96 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT
Official Title  ICMJE A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Human Immunodeficiency Virus Infections
Intervention  ICMJE
  • Drug: Efavirenz 600mg

    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 any other significant safety concern for the subject associated with remaining on the current regimen (e.g., hypersensitivity reaction, increased risk of suicide)
    Other Name: Efavirenz(Sustiva)600 mg
  • Drug: Boosted Lexiva

    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 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)
    Other Name: Fosamprenavir(Lexiva)
Study Arms  ICMJE
  • Experimental: Arm A : Boosted Lexiva plus Epzicom
    Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
    Intervention: Drug: Boosted Lexiva
  • Experimental: Arm B: Efavirenz plus Epzicom
    QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
    Intervention: Drug: Efavirenz 600mg
Publications * Kumar P, DeJesus E, Huhn G, Sloan L, Small CB, Edelstein H, Felizarta F, Hao R, Ross L, Stancil B, Pappa K, Ha B; SUPPORT Study Team. Evaluation of cardiovascular biomarkers in a randomized trial of fosamprenavir/ritonavir vs. efavirenz with abacavir/lamivudine in underrepresented, antiretroviral-naïve, HIV-infected patients (SUPPORT): 96-week results. BMC Infect Dis. 2013 Jun 7;13:269. doi: 10.1186/1471-2334-13-269.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2013)
101
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2008)
100
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00727597
Other Study ID Numbers  ICMJE COL 110408
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Princy Kumar, MD, Georgetown University
Study Sponsor  ICMJE Georgetown University
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Princy Kumar, MD Georgetown University
PRS Account Georgetown University
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP