Overview

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