Status:
WITHDRAWN
Trial of TDF/FTC + Raltegravir Versus TDF/FTC + Efavirenz in HIV-1-Infected Women
Lead Sponsor:
Rush University Medical Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV-1 Infections
Eligibility:
FEMALE
18-60 years
Phase:
PHASE3
Brief Summary
Raltegravir not only has a unique mechanism of action, but may also have other unique effects on suppression of viral replication, viral reservoir, and immune reconstitution in blood and other importa...
Detailed Description
This is a phase III, prospective, randomized (1:1), multicenter, open label study comparing the effects of two HAART regimens: * Arm A: Raltegravir 400 mg PO BID + TDF/FTC (Truvada, 300/200 mg) One P...
Eligibility Criteria
Inclusion
- Eligible subjects will be antiretroviral naïve (\< 7 days of HAART at any time prior to entry) with plasma HIV-1 RNA \> 50,000 copies/mL (obtained within 90 days prior to study entry by any laboratory that has a CLIA certification or its equivalent) and moderate immune suppression within 90 days prior to study entry.
- HIV-1 infected, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test. Alternatively, if a licensed ELISA is not available, two HIV-1 RNA values \>2000 copies/mL at least 24 hours apart performed by any laboratory that has CLIA certification or its equivalent may be used to document infection.
- Female sex, Age \> 18 and \< 60 years, Pre-menopausal.
- Screening CD4+ T-cell count between 200-350 cells/mm3 obtained within 90 days prior to study entry by any laboratory that has a CLIA certification or its equivalent.
- The absence of exclusionary resistance mutations on a genotypic resistance assay (absence of exclusionary NRTI or NNRTI resistance mutations by genotype testing)
- Antiretroviral (ARV) drug-naïve (defined as 7 days of ARV treatment at any time prior to entry).
- Laboratory values obtained within 45 days prior to study entry:
- Absolute neutrophil count (ANC) 500/mm3
- Hemoglobin 8.0 g/dL
- Platelet count 40,000/mm3
- AST (SGOT), ALT (SGPT), and alkaline phosphatase 5 ULN
- Total bilirubin 2.5 x ULN
- Calculated creatinine clearance ≥60 mL/min as estimated by the Cockcroft-Gault equation:
- For women, multiply the result by 0.85 = CrCl (mL/min)
- Negative serum or urine pregnancy test within 48 hours prior to initiating study medications unless otherwise specified by product labeling.
- Female candidates of reproductive potential is defined as women who have had regular menses over the preceding 24 months
- Contraception requirements for women who have not undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation).
- Female candidates of reproductive potential, who are participating in sexual activity that could lead to pregnancy, must agree to the following:
- If the regimen does not include EFV, they must agree to use at least one reliable method of contraception while receiving the protocol-specified drugs and for 6 weeks after stopping the medications.
- If the regimen includes EFV, they must agree to use two reliable methods of contraception: a barrier method of contraception (e.g., condoms, diaphragm, or cervical cap with or without spermicide) together with another reliable form of contraceptive (e.g., a second barrier method, an IUD, or a hormone-based contraceptive) while receiving EFV and for 6 weeks after stopping EFV.
Exclusion
- Menopausal (may affect quantity of genital tract secretions) or any serious illness that requires treatment and/or hospitalization until the patient completes therapy
- Any active infection, including co-infection with hepatitis B or C
- Any neoplasm
- Immunosuppressive therapy
- Requirement for any medications that are prohibited by any of the study treatments
- Significant liver or renal dysfunction
- Baseline resistance to any of the study drugs by genotypic testing
- NRTI: M41L, K65 R, D76N, T69D, K70R, L74V/I, y115F, Q151M, M184V, L210W, T215any, K219Q/E
- NNRTI:L100I, K103N, V106A/M, V108I, Y181C/I, Y188C/L/H, G190anyA/S
- Alcohol or substance abuse problems or psychiatric conditions that impair the ability of the subject to comply with the study protocol
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00984152
Start Date
June 1 2011
End Date
December 1 2013
Last Update
May 6 2015
Active Locations (5)
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1
Mt. Sinai Hospital
Chicago, Illinois, United States, 60608
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
4
The Ruth M. Rothstein CORE Center (of Cook County)
Chicago, Illinois, United States, 60622