Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
---|---|
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00028327 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Lamivudine/Zidovudine Drug: Nelfinavir mesylate Drug: Efavirenz Drug: Lamivudine Drug: Zidovudine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 250 |
There has been considerable debate over the management of HIV infected individuals admitted to the ICA. Mortality in HIV infected patients in the ICA correlates with the level of immune suppression. The majority of HIV infected individuals entering the ICA are antiretroviral naive. Despite the high mortality rates and the opportunity to intervene with antiretroviral therapy, physicians do not routinely administer highly active antiretroviral therapy (HAART) in the ICA. Early initiation of HAART, which improves immune function, could potentially reduce mortality. Numerous studies have shown that there is a dramatic drop in the HIV-1 RNA levels accompanied by an increase in the CD4 cell count within the first 2 to 4 weeks of therapy. Sufficient data now exist that antiretrovirals could be administered in the ICA with careful monitoring and attention to drug interactions. This study will evaluate the effect of HAART in patients admitted to the hospital with an AIDS-defining illness, pneumonia, or sepsis.
Upon entry into the study, patients are stratified according to a severity of illness score (SAPS I) and CD4 cell count. Patients then are assigned to 1 of 2 study arms: Arm A: HAART (lamivudine [3TC] and zidovudine [ZDV], or 3TC/ZDV, and nelfinavir [NFV] and efavirenz [EFV]); or an alternative HAART for 4 weeks. Arm B: No antiretroviral regimen. Evaluations of the following are performed: drug toxicity, immune status, viral load, arterial blood gas, ventilator parameters, and evolution of the presenting illness. Pharmacokinetic trough concentration analyses are performed on all patients in Arm A during 3 time points of their illness. Patients are followed for 24 weeks after entry. Patients in Arm A may elect to participate in two substudies. The first substudy will measure efavirenz and nelfinavir drug levels in the blood to determine how critical illness affects pharmacokinetics. The second substudy will evaluate the benefit of HAART in HIV infected patients being treated for pneumocystis carinii pneumonia.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, California | |
Univ of California San Francisco | |
San Francisco, California, United States, 94110 | |
Univ of California, San Diego | |
San Diego, California, United States, 92103 | |
Univ of Southern California | |
Los Angeles, California, United States, 90033-1079 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Maryland | |
Johns Hopkins Hosp | |
Baltimore, Maryland, United States, 21287 | |
United States, Missouri | |
Washington Univ School of Medicine | |
St Louis, Missouri, United States, 63108 | |
United States, New York | |
Beth Israel Med Ctr | |
New York, New York, United States, 10003 | |
United States, North Carolina | |
Duke Univ Med Ctr | |
Durham, North Carolina, United States, 27710 | |
United States, Washington | |
Univ of Washington | |
Seattle, Washington, United States, 98104 |
Study Chair: | Diane Havlir | |
Study Chair: | Denis Jones |
Study ID Numbers: | ACTG A5141, AACTG A5141, A5161s, A5162s |
Study First Received: | December 20, 2001 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00028327 |
Health Authority: | United States: Federal Government |
AIDS-Related Opportunistic Infections Zidovudine HIV Protease Inhibitors CD4 Lymphocyte Count Lamivudine Pneumonia |
Nelfinavir Reverse Transcriptase Inhibitors Antiretroviral Therapy, Highly Active Efavirenz Intensive Care Units Sepsis |
Efavirenz Opportunistic Infections Sexually Transmitted Diseases, Viral Acquired Immunodeficiency Syndrome Lamivudine Zidovudine Immunologic Deficiency Syndromes Virus Diseases |
Sepsis HIV Infections Critical Illness AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Nelfinavir Retroviridae Infections Pneumonia |
Antimetabolites Anti-Infective Agents HIV Protease Inhibitors RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |