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July 10, 1996

Antiretroviral Therapy for HIV Infection in 1996: Recommendations of an International Panel

Author Affiliations

for the International AIDS Society-USA
From Brown University School of Medicine, Providence, RI (Dr Carpenter); the University of Miami (Fla) School of Medicine (Dr Fischl); Harvard Medical School, Boston, Mass (Drs Hammer and Hirsch); The International AIDS Society-USA, San Francisco, Calif (Ms Jacobsen); Stanford (Calif) University Medical Center (Dr Katzenstein); St Paul's Hospital, Vancouver, British Columbia (Dr Montaner); University of California San Diego, and San Diego Veterans Affairs Medical Center (Dr Richman); the University of Alabama at Birmingham (Dr Saag); the University of Colorado School of Medicine, Denver (Dr Schooley); AIDS Research Consortium of Atlanta (Ga) (Dr Thompson); Istituto Superiore di Sanità, Rome, Italy (Dr Vella); Hôpital Bichat-Claude Bernard, X. Bichat Medical School, Paris, France (Dr Yeni); and the University of California San Francisco (Dr Volberding).

JAMA. 1996;276(2):146-154. doi:10.1001/jama.1996.03540020068031

Objective.  —To provide clinical recommendations for antiretroviral therapy for human immunodeficiency virus (HIV) disease with currently (mid 1996) available drugs. When to start therapy, what to start with, when to change, and what to change to were addressed.

Participants.  —A 13-member panel representing international expertise in antiretroviral research and HIV patient care was selected by the International AIDS Society—USA.

Evidence.  —Available clinical and basic science data, including phase 3 controlled trials, clinical endpoint data, virologic and immunologic endpoint data, interim analyses, studies of HIV pathophysiology, and expert opinions of panel members were considered. Recommendations were limited to drugs available in mid 1996.

Process.  —For each question posed, 1 or more member(s) reviewed and presented available data. Recommendations were determined by group consensus (January 1996); revisions as warranted by new data were incorporated by group consensus (February-May 1996).

Conclusions.  —Recent data on HIV pathogenesis, methods to determine plasma HIV RNA, clinical trial data, and availability of new drugs point to the need for new approaches to treatment. Therapy is recommended based on CD4+ cell count, plasma HIV RNA level, or clinical status. Preferred initial drug regimens include nucleoside combinations; at present protease inhibitors are probably best reserved for patients at higher progression risk. For treatment failure or drug intolerance, subsequent regimen considerations include reasons for changing therapy, available drug options, disease stage, underlying conditions, and concomitant medication(s). Therapy for primary (acute) infection, high-risk exposures to HIV, and maternal-to-fetal transmission are also addressed. Therapeutic approaches need to be updated as new data continue to emerge.