Status:
COMPLETED
Evolution of L74V or K65R Mutations in VIremic Subjects on Tenofovir Disoproxil Fumarate (TDF) or Abacavir (ABC) (EVITA)
Lead Sponsor:
Orlando Immunology Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicenter, open-label, non-randomized, dual-arm pilot study to investigate the prevalence of the reverse transcriptase (RT) resistance mutations, K65R/x or L74V/x, in HIV-1 plasma from sub...
Detailed Description
This is a multicenter, open-label, non-randomized, dual-arm pilot study to investigate the prevalence of the RT resistance mutations, K65R/x or L74V/x, in HIV-1 plasma from subjects experiencing confi...
Eligibility Criteria
Inclusion
- Confirmed first-time incomplete virologic suppression during treatment with at least 12 weeks of an ARV regimen consisting of TDF or ABC + FTC or 3TC + NNRTI or PI (TDF as Truvada or individually with FTC, and ABC as Epzicom or individually with 3TC). Confirmed first-time incomplete virologic suppression is defined as an initial plasma HIV-1 RNA response \< 400 copies/mL, and subsequent virologic rebound \> 400 copies/mL measured at two consecutive times.
- Screening HIV-1 RNA \< 20,000 copies/mL obtained within 30 days prior to study entry.
- Screening CD4 cell count ≥ 200 cells/mL.
- Screening HIV-1 genotype with M184V or at least one treatment-related primary mutation.
- Routine labs as demonstrated by last available lab panel to be:
- Hemoglobin \> 8.0 g/dL;
- Platelet count \> 50,000/mm3;
- AST (SGOT) \< 210 U/L;
- ALT (SGPT) \< 240 U/L;
- Alkaline phosphatase \< 625 U/L;
- Total bilirubin \< 3.25 mg/dL; and
- Calculated creatinine clearance ≥ 50 as estimated by the Cockcroft-Gault equation.
- If participating in sexual activity that could lead to pregnancy, female study subjects must use two forms of contraception, one of which must be a barrier method.
- Men and women aged ≥ 18 years.
- Ability and willingness of subjects to give written informed consent.
Exclusion
- Subjects with screening HIV-1 genotype that is wild-type or contains the resistance mutations K65R/x or L74V/x.
- Prior or current treatment with ARV regimen consisting of only NRTIs, ZDV or d4T, more than 2 NRTIs, ritonavir-boosted or dual PI regimen.
- Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Chronic treatment with prednisone at a daily dose of 10 mg or less is permitted. For non-serious illnesses, treatment of less than 21 days with larger doses of corticosteroids is permitted.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 7 days prior to study entry. NOTE: Oral candidiasis, vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses (as judged by the site investigator) have no restrictions.
- Unable to discontinue contraindicated current medications.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00312169
Start Date
April 1 2006
End Date
May 1 2008
Last Update
May 22 2008
Active Locations (11)
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1
Special Services Adult HIV Clinic
Fresno, California, United States, 93702
2
AltaMed Health Services Corporation
Los Angelos, California, United States, 90022
3
Shared Medical Research Foundation
Tarzana, California, United States, 91356
4
Tarzana Treatment Center
Tarzana, California, United States, 91356