Novel clinical trial designs for the development of new antiretroviral agents

AIDS

Volumn 26, Issue 8, 2012, Pages 899-907

  Mani, Nina ^a   Murray, Jeffrey ^b   Gulick, Roy M ^c   Josephson, Filip ^d   Miller, Veronica ^a   Miele, Peter ^b   Strobos, Jur ^a,e   Struble, Kimberly ^b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c WEILL CORNELL MEDICAL COLLEGE   (United States)

^d MEDICAL PRODUCTS AGENCY   (Sweden)

^e RxBio Inc   (United States)

Author keywords

antiretroviral; clinical trial design; HIV 1; noninferiority; optimized background regimen; superiority; treatment experienced; treatment naive

Indexed keywords

ANTIRETROVIRUS AGENT; ATAZANAVIR PLUS RITONAVIR; DARUNAVIR; DOLUTEGRAVIR; EFAVIRENZ; EFAVIRENZ PLUS RILPIVIRINE; ELVITEGRAVIR; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; LERSIVIRINE; LIPID; LOPINAVIR; LOPINAVIR PLUS RITONAVIR; PLACEBO; RALTEGRAVIR; RILPIVIRINE; RITONAVIR; RNA DIRECTED DNA POLYMERASE INHIBITOR; UNCLASSIFIED DRUG; VICRIVIROC; VIRUS RNA;

CLINICAL TRIAL (TOPIC); DOSE RESPONSE; DRUG EFFICACY; DRUG POTENCY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HEALTH CARE ORGANIZATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LIPID BLOOD LEVEL; MULTIDRUG RESISTANCE; PATIENT SELECTION; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK BENEFIT ANALYSIS; SIDE EFFECT; STUDY DESIGN; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VIRUS LOAD;

ANTI-RETROVIRAL AGENTS; CLINICAL TRIALS AS TOPIC; DRUG INDUSTRY; DRUGS, INVESTIGATIONAL; HIV INFECTIONS; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84861094901     PISSN: 02699370     EISSN: 14735571     Source Type: Journal    
DOI: 10.1097/QAD.0b013e3283519371     Document Type: Review

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