Potent Antiviral Therapy for Critically Ill HIV Infected Patients Admitted to Intensive Care
Randomized Study to Evaluate Immediate Potent Antiretroviral Therapy for HIV-Infected Subjects With CD4 Cell Counts Less Than 350 Cells/mm3 Admitted to Intensive Care Areas With an AIDS-Defining Illness, Pneumonia, or Sepsis
4 other identifiers
interventional
250
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2001
CompletedFirst Posted
Study publicly available on registry
December 21, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedMarch 2, 2011
July 1, 2004
December 20, 2001
February 28, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Univ of Southern California
Los Angeles, California, 90033-1079, United States
Univ of California, San Diego
San Diego, California, 92103, United States
Univ of California San Francisco
San Francisco, California, 94110, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Washington Univ School of Medicine
St Louis, Missouri, 63108, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Washington
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Diane Havlir
- STUDY CHAIR
Denis Jones
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
December 20, 2001
First Posted
December 21, 2001
Primary Completion
July 1, 2004
Last Updated
March 2, 2011
Record last verified: 2004-07