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A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT
This study is ongoing, but not recruiting participants.
First Received: July 31, 2008   Last Updated: August 18, 2009   History of Changes
Sponsor: Georgetown University
Collaborator: GlaxoSmithKline
Information provided by: Georgetown University
ClinicalTrials.gov Identifier: NCT00727597
  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.


Condition Intervention Phase
Human Immunodeficiency Virus Infections
Drug: Lexiva + Norvir + Epzicom
Drug: Sustiva + Epzicom
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg).
Drug: Lexiva + Norvir + Epzicom
Once daily (QD) regimen of Lexiva (fosamprenavir 1400 mg) + Norvir (ritonavir 100 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
B: Experimental
QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)
Drug: Sustiva + Epzicom
QD regimen of Sustiva (efavirenz 600 mg) + Epzicom (abacavir 600 mg / lamivudine 300 mg)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • INC1 Screening plasma HIV-1 RNA viral load >5000 copies/mL
  • INC2 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);
  • INC3 Adult (≥18 years)
  • INC4 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)
  • INC5 Negative test for the HLA-B*5701 allele
  • INC6 Ability and willingness to give written informed consent
  • INC7 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:

    a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal); or, b. Childbearing potential with a negative pregnancy test at screen and agrees to use one of the following methods of contraception (any contraception method must be used consistently and correctly, i.e., in accordance with both the Prescribing Information and the instructions of a physician): 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. Note: Hormonal contraception is not recommended for use in conjunction with Lexiva due to decreased efficacy of contraception as well as increased risk of hepatic transaminase elevation. All applicable Prescribing Information should be consulted.

    v. Sterilization (female subject or male partner of female subject)

Exclusion Criteria:

  • EXC1 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
  • EXC2 Positive for Hepatitis B surface antigen (HBsAg+)
  • EXC3 Requirement for active treatment for hepatitis C virus infection, as indicated by both a positive HCV 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
  • EXC4 Currently pregnant, intending to become pregnant during the study period, or breast-feeding
  • EXC5 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.
  • EXC6 Active or suspected drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
  • EXC7 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
  • EXC8 Active or acute CDC Clinical Category C event at screening. (Note: Treatment for the acute event must have been completed at least 28 days prior to screening.)
  • EXC9 Clinically relevant pancreatitis or clinically relevant hepatitis at screening
  • EXC10 Hgb<8g/dl, platelet count <50,000/mm3, calculated creatinine clearance <50ml/min via Cockroft-Gault equation, or AST or ALT > 5X the ULN
  • EXC11 Any Grade 4 laboratory abnormality
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727597

Locations
United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
GlaxoSmithKline
Investigators
Principal Investigator: Princy Kumar, MD Georgetown University
  More Information

No publications provided

Responsible Party: Georgetown University ( Princy N. Kumar, MD )
Study ID Numbers: COL 110408
Study First Received: July 31, 2008
Last Updated: August 18, 2009
ClinicalTrials.gov Identifier: NCT00727597     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Infective Agents
Efavirenz
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 09, 2009