HIV InfectionsPhase 2NCT00000921
The Effects of Prednisone on HIV Levels and the Immune System
A Phase 2 study testing Prednisone in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give prednisone to HIV-infected patients. Prednisone is a corticosteroid, a hormone produced by the body that inhibits immune cell responses. 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?
- Prednisone
- How many people
- 118 participants
- Where
- 18 sitesUnited States
- Study dates
- Aug 1996to Jun 2002
- Phase
- Phase 2
- 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
- You may be eligible for this study if you:
- Are HIV-positive.
- Have a CD4 cell count of 200-600 cells/mm3 within 30 days of study entry. (This study has been changed. You now must have a CD4 cell count of 200-700 cells/mm3 within 45 days of study entry.)
- Have had your viral load measured within 30 days of study entry.
- Have been on stable anti-HIV therapy with at least two anti-HIV agents for at least 12 weeks, and you intend to remain on this therapy during the study.
- Are at least 18 years of age.
- Agree to abstain from sex or use effective methods of birth control during the study and for 30 days after.
Who cannot join
- You will not be eligible for this study if you:
- Abuse alcohol or drugs or have a serious psychological condition.
- Are allergic to prednisone or other corticosteroids.
- Have a history of opportunistic (AIDS-related) infections, including cytomegalovirus (CMV), Mycobacterium avium complex (MAC), or Kaposi's sarcoma (KS).
- Have a history of a serious medical condition, including heart problems, tuberculosis (TB), cancer, diabetes, or osteoporosis.
- Are being treated for herpes at study entry.
- Have received certain medications, including blood pressure medication.
- Are pregnant or breast-feeding.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
Northwestern Univ Med School
Chicago, Illinois, 60611
Cook County Hosp
Chicago, Illinois, 60612
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Case Western Reserve Univ
Cleveland, Ohio, 44106
MetroHealth Med Ctr
Cleveland, Ohio, 441091998
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
Queens Med Ctr
Honolulu, Hawaii, 96816
Univ of Hawaii / Leahi Hosp
Honolulu, Hawaii, 96816
Univ of Hawaii
Honolulu, Hawaii, 96816
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
Univ of Minnesota
Minneapolis, Minnesota, 55455
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Mount Sinai Med Ctr
New York, New York, 10029
Univ of Washington
Seattle, Washington, 98104
About this study
Official title: A Phase II, Randomized, Placebo-Controlled Study of the Immunologic and Virologic Effects of Prednisone on HIV-1 Infection
The purpose of this study is to see if it is safe and effective to give prednisone to HIV-infected patients.
Prednisone is a corticosteroid, a hormone produced by the body that inhibits immune cell responses. Prednisone may be able to lower the level of HIV in the body (viral load) by reducing the number of cells that HIV can infect. At the same time, prednisone may be able to increase CD4 cell counts (cells of the immune system that fight infection).
Read the detailed description
By inhibiting cellular activation, corticosteroids such as prednisone may inhibit HIV expression and reduce the population of potentially infectable cells. Furthermore, no studies have been performed to systematically evaluate immune function in prednisone-treated, HIV-infected patients or the immune mechanisms that may facilitate increases in CD4+ cell number. This study explores this issue.
Patients are separated into 2 arms according to whether or not they are currently receiving a protease inhibitor (PI) as part of their antiretroviral (ARV) therapy regimen (PI vs no PI therapy). Arm I: Current stable ARV therapy plus prednisone for 8 weeks, followed by 4 weeks at half the prior dose, then a 2-week taper. Arm II: Current stable ARV therapy plus prednisone placebo for 12 weeks.
- Conditions
- HIV Infections
- Being tested
- Prednisone
- Keywords
- Drug Therapy, Combination, Prednisone, Anti-HIV Agents
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startAug 1996
- Primary completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 118 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Wallis R, Study chairJacobson J, Study chairKalayjian R, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000921
- Sponsor's protocol ID
- ACTG 349
- Status last verified
- Jun 2003
- First submitted
- 2 Nov 1999
- Last updated
- 23 Feb 2011
- Results posted
- No
Publications
Wallis RS, Kalayjian R, Jacobson JM, Fox L, Purdue L, Shikuma CM, Arakaki R, Snyder S, Coombs RW, Bosch RJ, Spritzler J, Chernoff M, Aga E, Myers L, Schock B, Lederman MM. A study of the immunology, virology, and safety of prednisone in HIV-1-infected subjects with CD4 cell counts of 200 to 700 mm(-3). J Acquir Immune Defic Syndr. 2003 Mar 1;32(3):281-6. doi: 10.1097/00126334-200303010-00006.
PubMed 12626887
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Placebo-Controlled Study of the Immunologic and Virologic Effects of Prednisone on HIV-1 Infection
- ClinicalTrials.gov ID
- NCT00000921
- Acronym / sponsor ID
- ACTG 349
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Prednisone, Anti-HIV Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 1996
- Primary completion
- Jun 2002 (actual)
- First posted
- 31 Aug 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.
The purpose of this study is to see if it is safe and effective to give prednisone to HIV-infected patients.
Prednisone is a corticosteroid, a hormone produced by the body that inhibits immune cell responses. Prednisone may be able to lower the level of HIV in the body (viral load) by reducing the number of cells that HIV can infect. At the same time, prednisone may be able to increase CD4 cell counts (cells of the immune system that fight infection).
Detailed description
By inhibiting cellular activation, corticosteroids such as prednisone may inhibit HIV expression and reduce the population of potentially infectable cells. Furthermore, no studies have been performed to systematically evaluate immune function in prednisone-treated, HIV-infected patients or the immune mechanisms that may facilitate increases in CD4+ cell number. This study explores this issue.
Patients are separated into 2 arms according to whether or not they are currently receiving a protease inhibitor (PI) as part of their antiretroviral (ARV) therapy regimen (PI vs no PI therapy). Arm I: Current stable ARV therapy plus prednisone for 8 weeks, followed by 4 weeks at half the prior dose, then a 2-week taper. Arm II: Current stable ARV therapy plus prednisone placebo for 12 weeks.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are HIV-positive.
- Have a CD4 cell count of 200-600 cells/mm3 within 30 days of study entry. (This study has been changed. You now must have a CD4 cell count of 200-700 cells/mm3 within 45 days of study entry.)
- Have had your viral load measured within 30 days of study entry.
- Have been on stable anti-HIV therapy with at least two anti-HIV agents for at least 12 weeks, and you intend to remain on this therapy during the study.
- Are at least 18 years of age.
Key exclusion criteria (8 listed)
- Abuse alcohol or drugs or have a serious psychological condition.
- Are allergic to prednisone or other corticosteroids.
- Have a history of opportunistic (AIDS-related) infections, including cytomegalovirus (CMV), Mycobacterium avium complex (MAC), or Kaposi's sarcoma (KS).
- Have a history of a serious medical condition, including heart problems, tuberculosis (TB), cancer, diabetes, or osteoporosis.
- Are being treated for herpes at study entry.
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 |
|---|---|---|
| Prednisone | 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 23 Feb 2011.
- Background: PubMed 12626887Wallis RS, Kalayjian R, Jacobson JM, Fox L, Purdue L, Shikuma CM, Arakaki R, Snyder S, Coombs RW, Bosch RJ, Spritzler J, Chernoff M, Aga E, Myers L, Schock B, Lederman MM. A study of the immunology, virology, and safety of prednisone in HIV-1-infected subjects with CD4 cell counts of 200 to 700 mm(-3). J Acquir Immune Defic Syndr. 2003 Mar 1;32(3):281-6. doi: 10.1097/00126334-200303010-00006.
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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.
Wallis R study chair
Jacobson J study chair
Kalayjian R study chair
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisone in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 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 7 inclusion and 8 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 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
On the ClinicalTrials.gov record for NCT00000921, which also lists 1 linked publication.
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 23 Feb 2011; AzTrials last refreshed its copy on 8 Nov 2026.