Clinical trial NCT00708162 (phase 3, status: completed)
Conditions: hiv infection
ICD codes: Z21
Drugs: elvitegravir, raltegravir, evg placebo, ral placebo, background regimen
SMILES: [H][C@@](CO)(C(C)C)N1C=C(C(O)=O)C(=O)C2=C1C=C(OC)C(CC1=C(F)C(Cl)=CC=C1)=C2, CN1C(=O)C(O)=C(N=C1C(C)(C)NC(=O)C1=NN=C(C)O1)C(=O)NCC1=CC=C(F)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CCO
Eligibility criteria:

        Inclusion Criteria:

          -  Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening

          -  Documented resistance or at least six months experience prior to screening with two or
             more different classes of antiretroviral agents

          -  Stable antiretroviral regimen for at least 30 days prior to screening: however,
             participants may discontinue the antiretroviral regimen after screening and remain off
             therapy until baseline at the discretion of the investigator

          -  Eligible to receive one of the fully-active ritonavir-boosted-PIs, and an allowed
             second agent

          -  Normal ECG

          -  Adequate renal function (estimated glomerular filtration rate according to the
             Cockcroft-Gault formula ≥ 60 mL/min)

          -  Hepatic transaminases ≤ 5 × upper limit of normal

          -  Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

          -  Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥
             50,000/mm^3; hemoglobin ≥ 8.5 g/dL)

          -  Serum amylase < 1.5 × the upper limit of the normal range

          -  Negative serum pregnancy test (females of childbearing potential only)

          -  Males and females of childbearing potential must agree to use highly effective
             contraception methods

          -  Age ≥ 18 years

          -  Life expectancy ≥ 1 year

          -  Ability to understand and sign a written informed consent form

        Exclusion Criteria:

          -  New AIDS-defining condition diagnosed within the 30 days prior to screening

          -  Prior treatment with any HIV-1 integrase inhibitor

          -  Participants experiencing ascites

          -  Participants experiencing encephalopathy

          -  Females who are breastfeeding

          -  Positive serum pregnancy test at any time during the study (female of childbearing
             potential)

          -  Participants receiving ongoing therapy with any disallowed medication

          -  Current alcohol or substance use judged by the investigator to potentially interfere
             with study compliance

          -  Malignancy other than cutaneous Kaposi's sarcoma or basal cell carcinoma

          -  Active, serious infections (other than HIV-1 infection) requiring parenteral
             antibiotic or antifungal therapy within 30 days prior to baseline

          -  Participation in any other clinical trial (except for the etravirine or maraviroc
             expanded access program), without prior approval from sponsor

          -  Any other clinical condition or prior therapy that would make participants unsuitable
             for the study

          -  Known hypersensitivity to study drug, metabolites or formulation excipients