Study of Options for Second-Line Effective Combination Therapy (SELECT)
Condition: HIV-1 Infection
Intervention: Lopinavir/ritonavir; Lopinavir/ritonavir; Raltegravir; Emtricitabine/tenofovir disoproxil fumarate; Abacavir/lamivudine/zidovudine; Abacavir/lamivudine; Lamivudine/zidovudine; Abacavir; Zidovudine; Lamivudine
Intervention description: Lopinavir 400mg/ritonavir 100mg (given as two LPV 200mg/RTV 50mg fixed-dose combination tablets) orally twice daily, with or without food, throughout follow-up.; Lopinavir 400mg/ritonavir 100mg (given as three LPV 133.3 mg/RTV 33.3 mg fixed-dose combination soft gelatin capsules) orally twice daily, with food, throughout follow-up.; Raltegravir 400 mg tablet orally twice daily, with or without food, throughout follow-up.; Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily, with or without food, throughout follow-up.; Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily, with or without food, throughout follow-up.; Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily, with or without food, throughout follow-up.; Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily, with or without food, throughout follow-up.; Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily, with or without food, throughout follow-up.; Zidovudine 300 mg tablet orally twice daily, with or without food, throughout follow-up.; Lamivudine 150 mg tablet orally twice daily, with or without food, throughout follow-up.
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Lamivudine; Emtricitabine; Zidovudine; Raltegravir Potassium; Abacavir; Lamivudine, zidovudine drug combination; Dideoxynucleosides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 515.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study was conducted on people who were taking their first anti-HIV drug regimen
      (including an Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), a type of anti-HIV
      drug) but the drugs in this regimen were not doing a good job of fighting their HIV
      infection.

      The main purpose of this study was to compare two other anti-HIV drug regimens to see how
      well they fight HIV. The study also looked at how well participants tolerate the drug
      regimens and how safe they are.

      The study was designed to determine whether taking the combination of lopinavir/ritonavir
      (LPV/r) plus raltegravir (RAL) works as well as what is usually used for second-line therapy:
      LPV/r plus the best-available nucleoside (nucleotide) reverse transcriptase inhibitor (NRTI)
      combination. Testing a regimen that does not include any NRTIs was important because NRTIs
      may no longer work for patients who received them as part of their first treatment regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected

          -  Confirmation of first-line virologic failure

          -  Certain laboratory values obtained within 45 days prior to study entry. More
             information on this criterion can be found in the study protocol.

          -  Negative pregnancy test within 48 hours prior to study entry.

          -  Must refrain from participating in a conception process, and, if participating in
             sexual activity that could lead to pregnancy, must use at least one acceptable type of
             contraceptive. More information on this criterion can be found in the study protocol.

          -  Karnofsky performance score >= 70 within 45 days prior to study entry.

          -  Ability and willingness of participant or legal guardian/representative to provide
             informed consent.

          -  No intention to relocate away from current geographical area of residence for the
             duration of study participation.

        Exclusion Criteria:

          -  Use of any immunomodulator, HIV vaccine, or other investigational therapy within 45
             days prior to study entry, with the exception of a tapering course of corticosteroids
             as acute therapy for pneumocystis jiroveci pneumonia (PCP) or acute asthma/chronic
             obstructive pulmonary disease flare and/or prednisone at a daily dose of <10 mg
             (physiologic replacement dose).

          -  If the potential participant has had resistance testing, evidence of broad NRTI
             cross-resistance that, in the opinion of the investigator, would not allow selection
             of an effective NRTI combination if the participant were randomized to the LPV/r +
             best available NRTIs arm.

          -  Prior exposure to a Protease Inhibitor.

          -  Known history of congenital long QT syndrome, hypokalemia, or planned use of other
             drugs that prolong the QT interval.

          -  Pregnancy or breast-feeding.

          -  Known history of chronic hepatitis B virus (HBV) infection or current HBV infection
             defined by the presence of hepatitis B surface antigen in serum or plasma.

          -  Active tuberculosis (TB) requiring treatment with rifampicin.

          -  Previously diagnosed malignancies other than basal cell carcinoma and cutaneous Kaposi
             sarcoma.

          -  Requirement for taking any medications that are prohibited with the study drugs. More
             information on this criterion can be found in the study protocol, section 5.4.

          -  Known allergy/sensitivity or any hypersensitivity to components of study drugs or
             their formulation.

          -  Active drug or alcohol use or dependence or other condition that, in the opinion of
             the site investigator, would interfere with adherence to study requirements.

          -  Serious illness requiring systemic treatment and/or hospitalization until candidate
             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.