A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT
Information source: Georgetown University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Human Immunodeficiency Virus Infections
Intervention: Efavirenz 600mg (Drug); Boosted Lexiva (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Georgetown University Official(s) and/or principal investigator(s): Princy Kumar, MD, Principal Investigator, Affiliation: Georgetown University
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.
Clinical Details
Official title: A Study in Underrepresented Patient Population or Regimen Tolerability: SUPPoRT
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Subjects Needing to Switch Comparator Drugs (FPV/r or EFV)Number of Subjects Developing Any Treatment-related Grade 3-4 Adverse Events
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Georgetown University, Washington, District of Columbia 20007, United States
Additional Information
Starting date: July 2008
Last updated: June 28, 2013
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