HIV InfectionsPhase 3NCT00028327
Potent Antiviral Therapy for Critically Ill HIV Infected Patients Admitted to Intensive Care
A Phase 3 study testing Lamivudine/Zidovudine, Nelfinavir mesylate and Efavirenz in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Lamivudine/Zidovudine, Nelfinavir mesylate and Efavirenz
- How many people
- 250 participants
- Where
- 9 sitesUnited States
- Study dates
- Start not givento Jul 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Certain medications
- Uncertain availability for 6 month course of study
- Require regular stomach suctioning
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Duke Univ Med Ctr
Durham, North Carolina, 27710
Univ of Southern California
Los Angeles, California, 90033-1079
Univ of Miami School of Medicine
Miami, Florida, 331361013
Beth Israel Med Ctr
New York, New York, 10003
Univ of California, San Diego
San Diego, California, 92103
Univ of California San Francisco
San Francisco, California, 94110
Univ of Washington
Seattle, Washington, 98104
Washington Univ School of Medicine
St Louis, Missouri, 63108
About this 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
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- Lamivudine/Zidovudine, Nelfinavir mesylate, Efavirenz, Lamivudine, Zidovudine
- Keywords
- 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
- Medical subject headings
- HIV Infections, AIDS-Related Opportunistic Infections, Pneumonia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine/ZidovudineDrug
Nelfinavir mesylateDrug
EfavirenzDrug
LamivudineDrug
ZidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2001 (estimated)
- Primary completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 250 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Diane Havlir, Study chairDenis Jones, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028327
- Sponsor's protocol ID
- ACTG A5141
- Other IDs
- AACTG A5141, A5161s, A5162s
- Status last verified
- Jul 2004
- First submitted
- 20 Dec 2001
- Last updated
- 2 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00028327
- Acronym / sponsor ID
- ACTG A5141
- Conditions
- HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Zidovudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, Lamivudine, Pneumonia, Nelfinavir, Reverse Transcriptase Inhibitors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- Jul 2004 (actual)
- First posted
- 21 Dec 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamivudine/Zidovudine | Drug | – |
| Nelfinavir mesylate | Drug | – |
| Efavirenz | Drug | – |
| Lamivudine | Drug | – |
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Havlir study chair
Denis Jones study chair
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lamivudine/Zidovudine, Nelfinavir mesylate and Efavirenz in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.