Contraceptive Research and Development Organization

Transcription

1 COMMONLY USED ABBREVIATIONS AND ACRONYMS IN MTN PROTOCOLS 3TC ACASI AE AIDS ALT ART ARV AST AUC BMD BV CDC cgmp CFR CI CONRAD Cmax Cmin CORE C-PMPA lamivudine audio computer-assisted self interview adverse event acquired immunodeficiency syndrome alanine transaminase antiretroviral therapy antiretroviral aspartate aminotransferase area under the curve bone mineral density bacterial vaginosis Centers for Disease Control current good manufacturing practices Code of Federal Regulations confidence intervals Contraceptive Research and Development Organization maximum serum concentration minimum serum concentration Coordinating and Operations Center radiolabeled tenofovir

2 2 CRF CROI CRPMC CTA CWG d4t DAIDS DXA DMPA DNA DSMB EAE EC EC50 EFV FDA FHCRC FHI FTC FTC/TDF GCP GEE HBsAb HBsAg HBV case report form Conference on Retroviruses and Opportunistic Infections Clinical Research Products Management Center clinical trial agreement Community Working Group stavudine Division of AIDS Dual energy X-ray absorptiometry depot medroxyprogesterone acetate deoxyribonucleic acid Data and Safety Monitoring Board expedited adverse event ethics committee 50% effective concentration efavirenz Food and Drug Administration Fred Hutchison Cancer Research Center Family Health International emtricitabine emtricitabine/tenofovir disoproxil fumarate Good Clinical Practices generalized estimating equations hepatitis B surface antibody hepatitis B surface antigen hepatitis B virus

3 3 HEC HIV HPTN HR IC-EC IC50 50% IATA IFN-γ IgA IL-2 IND IoR IRB ITT IUCD KOH LDMS LLN LPV MTN NIAID NICHD NIMH NIH NL hydroxyethylcellulose human immunodeficiency virus HIV Prevention Trials Network hazard ratio intracellular-extracellular inhibitory concentration International Air Transport Association interferon gamma immunoglobulin A interleukin-2 investigational new drug Investigator of Record Institutional Review Board intention to treat intrauterine contraceptive device potassium hydroxide Laboratory Data Management System lower limit of normal lopinavir Microbicide Trials Network National Institute of Allergy and Infectious Disease National Institute of Child Health and Human Development National Institute of Mental Health (United States) National Institutes of Health network laboratory

4 4 NNRTI NRTI NVP OHRP p-y PCR PD PID PK PMPA PMPApp PoR PrEP PUEV PSRT RSC RNA RT RTI RTV RT-PCR SCHARP SDA SDMC SHIV non-nucleoside reverse transcriptase inhibitor nucleoside reverse transcriptase inhibitor nevirapine Office of Human Research Protections person-years polymerase chain reaction pharmacodynamic pelvic inflammatory disease pharmacokinetic(s) 9-R-2-phosphonomethoxypropyl adenine tenofovir diphosphate Pharmacist of Record pre-exposure prophylaxis Product Use End Visit Protocol Safety Review Team Regulatory Support Center ribonucleic acid reverse transcriptase reproductive tract infection ritonavir real time polymerase chain reaction Statistical Center for HIV/AIDS Research and Prevention strand displacement amplification Statistical Data Management Center simian/human immunodeficiency virus

5 5 SMC SOP SQ SSP STI TDF ULN UNAIDS UTI VOICE WB WHO ZDV Study Monitoring Committee standard operating procedure subcutaneous study specific procedures sexually transmitted infection tenofovir disoproxil fumarate upper limits of normal Joint United Nations Program on HIV/AIDS urinary tract infection Vaginal and Oral Interventions to Control the Epidemic Western blot World Health Organization zidovudine