Trial of TDF/FTC + Raltegravir Versus TDF/FTC + Efavirenz in HIV-1-Infected Women

Inclusion Criteria

• •1. 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.
• •2. 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.
• •3. Female sex, Age \> 18 and \< 60 years, Pre-menopausal.
• •4. 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.
• •5. The absence of exclusionary resistance mutations on a genotypic resistance assay (absence of exclusionary NRTI or NNRTI resistance mutations by genotype testing)
• •6. Antiretroviral (ARV) drug-naïve (defined as 7 days of ARV treatment at any time prior to entry).
• •7. 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)
• •8. 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
• •9. Contraception requirements for women who have not undergone surgical sterilization (e.g., hysterectomy, or bilateral oophorectomy, or bilateral tubal ligation).
• •10. 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.