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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Efavirenz; Lamivudine; Lamivudine, zidovudine drug combination; Nelfinavir; Zidovudine

Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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