Potent Antiviral Therapy for Critically Ill HIV Infected Patients Admitted to Intensive Care

Completed · Phase 3

Conditions studied: HIV Infections

In brief

Many HIV infected patients admitted to the intensive care area (ICA) have never taken anti-HIV drugs. The purpose of this study is to learn whether starting anti-HIV drugs while patients are in an ICA will help them to survive and get better faster. This study will also evaluate patients who, though not in an ICA, have been admitted to the hospital for serious illnesses or infections.

Key facts

Study ID

NCT00028327

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

250

Last updated by the study team

2011-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infection
• CD4 cell count less than 350 cells/mm3 within 120 hours prior to study entry
• Admission to an ICA (or to any part of the hospital with an arterial blood gas PaO2/FiO2 ratio of < 200 or SAPS I score > 13) within 120 hours prior to study entry
• Admitted to the hospital for sepsis, pneumonia, or other AIDS-defining disease
• Acceptable methods of contraception

You may not qualify if…

• Known resistance or intolerance to antiretroviral drugs that precludes use of an effective HAART regimen of FDA approved drugs, excluding abacavir or full-dose ritonavir
• More than 7 days of HAART (a regimen of at least 3 drugs that includes a protease inhibitor, a nonnucleoside reverse transcriptase inhibitor, or three nucleoside analogues) within 4 weeks prior to study entry
• Investigational drug within 14 days prior to study entry
• Pregnant or breast-feeding
• Allergy or sensitivity to any of the study drugs that cannot be substituted with another drug
• CNS mass lesion or bacterial meningitis
• Certain medications
• Uncertain availability for 6 month course of study
• Require regular stomach suctioning

Where it is running

• Univ of Southern California — Los Angeles, California, United States
• Univ of California, San Diego — San Diego, California, United States
• Univ of California San Francisco — San Francisco, California, United States
• Univ of Miami School of Medicine — Miami, Florida, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Washington Univ School of Medicine — St Louis, Missouri, United States
• Beth Israel Med Ctr — New York, New York, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Univ of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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