A randomized study to evaluate injection site reactions using three different enfuvirtide delivery mechanisms (the OPTIONS study)

Antiviral Therapy

Volumn 13, Issue 3, 2008, Pages 449-453

  Boyd, Mark A ^a   Truman, Matt ^b   Hales, Gillian ^b   Anderson, Jonathan ^c   Dwyer, Dominic E ^d   Carr, Andrew ^e  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b Roche Products Pty Ltd   (Australia)

^c Carlton Clinic   (Australia)

^d WESTMEAD HOSPITAL   (Australia)

^e ST VINCENT S HOSPITAL   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ENFUVIRTIDE; VIRUS RNA; ANTIVIRUS AGENT; GLYCOPROTEIN GP 41; PEPTIDE FRAGMENT;

ADULT; ARTICLE; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG WITHDRAWAL; ECCHYMOSIS; FEMALE; HEMATOMA; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INJECTION SITE DISCOMFORT; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE NODULE; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEEDLE; OPEN STUDY; PARALLEL DESIGN; PARESTHESIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; STATISTICAL SIGNIFICANCE; TREATMENT DURATION; VIRUS LOAD; AUSTRALIA; BLOOD; DRUG EFFECT; EQUIPMENT DESIGN; GENETICS; HUMAN IMMUNODEFICIENCY VIRUS; JET INJECTION; MIDDLE AGED; PAIN; PAIN ASSESSMENT; PATIENT SATISFACTION; SKIN DISEASE; SUBCUTANEOUS DRUG ADMINISTRATION; TREATMENT OUTCOME; VIROLOGY;

ADULT; ANTIVIRAL AGENTS; AUSTRALIA; EQUIPMENT DESIGN; FEMALE; HIV; HIV ENVELOPE PROTEIN GP41; HIV INFECTIONS; HUMANS; INJECTIONS, JET; INJECTIONS, SUBCUTANEOUS; MALE; MIDDLE AGED; NEEDLES; PAIN; PAIN MEASUREMENT; PATIENT SATISFACTION; PEPTIDE FRAGMENTS; RNA, VIRAL; SKIN DISEASES; TREATMENT OUTCOME; VIRAL LOAD;

EID: 45749137863     PISSN: 13596535     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. Lalezari JP, Henry K, O'Hearn M, et al. Enfuvirtide, an HIV-1 fusion inhibitor, for drug-resistant HIV infection in North and South America. N Engl J Med 2003; 348:2175-2185.
2. Lazzarin A, Clotet B, Cooper DA, et al. Efficacy of enfuvirtide in patients infected with drug-resistant HIV-1 in Europe and Australia. N Engl J Med 2003; 348:2186-2195.
3. Hicks CB, Cahn P, Cooper DA, et al. Durable efficacy of tipranavir-ritonavir in combination with an optimised background regimen of antiretroviral drugs for treatment-experienced HIV-1-infected patients at 48 weeks in the Randomized Evaluation of Strategic Intervention in multi-drug reSistant patients with Tipranavir (RESIST) studies: an analysis of combined data from two randomised open-label trials. Lancet 2006; 368:466-475.
4. Clotet B, Bellos N, Molina JM, et al. Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials. Lancet 2007; 369:1169-1178.
5. Grinsztejn B, Nguyen BY, Katlama C, et al. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet 2007; 369:1261-1269.
6. Dwyer DE, Workman C, Hales G, Amin J, Cooper D, Miller J. Enfuvirtide in HIV-1-infected individuals changing therapy to a nucleoside reverse transcriptase inhibitor sparing regimen: the ALLIANCE Study. Antivir Ther 2006; 11:409-419.
7. Trottier B, Walmsley S, Reynes J, et al. Safety of enfuvirtide in combination with an optimized background of antiretrovirals in treatment-experienced HIV-1-infected adults over 48 weeks. J Acquir Immune Defic Syndr 2005; 40:413-421.
8. Harris M, Joy R, Larsen G, Valyi M, Walker E, Frick LW, et al. Enfuvirtide plasma levels and injection site reactions using a needle-free gas-powered injection system (Biojector). AIDS 2006; 20:719-723.
9. Loutfy M, Harris M, Raboud J, et al. A large prospective study assessing injection site reactions, quality of life and preference in patients using the Biojector vs standard needles for enfuvirtide administration. HIV Med 2007; 8:427-432.
10. Shalit P, True A, Thommes JA. Quality of life and tolerability after administration of enfuvirtide with a thin-walled needle: QUALITE Study. HIV Clin Trials 2007; 8:24-35.
11. Gottlieb M, True A, Evans R, et al. Needle-free administration of enfuvirtide significantly reduces incidence of painful injection site reactions: results from a single blind, randomized, controlled study. The 46th International Conference on Antimicrobials and Chemotherapy. September 27-30, 2006, San Francisco, CA. Poster H-1905b.