Challenges of antiretroviral treatment in transient and drug-using populations: the SUN study.
This is an open-label, single-arm, phase 3b study (part of phase 3 development) to evaluate the efficacy and safety of Fortovase-soft gelatin formulation (saquinavir-SGC), combined with zidovudine (ZDV) and lamivudine (3TC), human immune deficiency virus type 1 in (HIV-1)-positive, antiretroviral-naive individuals. Forty-two HIV-1-positive adults with plasma HIV RNA >10,000 copies per milliliter (Roche Amplicor HIV Monitor assay) and CD4 cell count >100 cells/mm(3) were treated with SQV-SGC, 1200 mg three times per day; ZDV, 300 mg; and 3TC, 150 mg each twice per day for 48 weeks. High proportions were drug users (26%), demonstrated psychiatric disorders (alcohol abuse [14%]/depression [14%]), or were inadequately housed (5%). At 48 weeks, 50% of patients achieved viral suppression <400 copies per milliliter with 43% <20 copies per milliliter using an intent-to-treat analysis (missing values counted as virological failures). Corresponding proportions for patients remaining on therapy at 48 weeks were 91% <400 copies per milliliter and 78% <20 copies per milliliter. Most adverse events were mild. Saquinavir-SGC combined with ZDV and 3TC, achieved potent and durable HIV RNA suppression and was well tolerated over 48 weeks in an antiretroviral-naive population including high proportions of individuals considered difficult to treat, such as drug users, people with psychiatric problems and homeless individuals.
Sension
M G
MG
North Broward Hospital District, Fort Lauderdale, Florida, USA. Mgension@aol.com
Farthing
C
C
Shaffer
A G
AG
Graham
E
E
Siemon-Hryczyk
P
P
Pilson
R S
RS
D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods* / Q000523:psychology*; D018791:CD4 Lymphocyte Count; D002214:Capsules; D002626:Chemistry, Pharmaceutical; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000209:etiology / Q000276:immunology / Q000523:psychology* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000737:chemistry / Q000627:therapeutic use*; D015497:HIV-1; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use*; D008297:Male; D001523:Mental Disorders / Q000150:complications / Q000523:psychology*; D010349:Patient Compliance / Q000523:psychology* / Q000706:statistics & numerical data; D010865:Pilot Projects; D016016:Proportional Hazards Models; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D019258:Saquinavir / Q000737:chemistry / Q000627:therapeutic use*; D015819:Substance Abuse, Intravenous / Q000150:complications / Q000523:psychology*; D014171:Transients and Migrants / Q000523:psychology* / Q000706:statistics & numerical data; D016896:Treatment Outcome; D019562:Viral Load; D015215:Zidovudine / Q000627:therapeutic use*
D002214:Capsules; D017320:HIV Protease Inhibitors; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; D015215:Zidovudine; D019258:Saquinavir