HIV InfectionsPhase 2NCT00000819
A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)
A Phase 2 study testing Prednisone in people with HIV Infections and AIDS-Associated Nephropathy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
To determine the efficacy and safety of prednisone in patients with HIV-associated nephropathy. To determine the effects of prednisone on serum creatinine, urinary protein, and creatinine clearance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, AIDS-Associated Nephropathy
- What is being tested?
- Prednisone
- How many people
- 54 participants
- Where
- 8 sitesUnited States
- Study dates
- Start not givento Sep 1996
- 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
- Patients must have:
- HIV infection.
- Biopsy-confirmed glomerulosclerosis and/or mesangial proliferation within 90 days prior to study entry.
- Mild to severe renal insufficiency that is stable or worsening.
- No AIDS-defining opportunistic infections or malignancies.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Poorly controlled hypertension or diabetes mellitus.
- Peptic ulcer disease with gastrointestinal bleeding.
- Active symptomatic bacterial, protozoal, fungal, or viral infections (other than HIV disease).
- Superimposed renal disease that is due to processes other than focal glomerulosclerosis or mesangial proliferation, including but not limited to obstructive uropathy, acute tubular necrosis, and prerenal azotemia.
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- Emotional problems sufficient to prevent adequate compliance with study therapy.
- Concurrent Medication:
- Excluded:
- IV amphotericin B.
- IV aminoglycosides.
- IV foscarnet.
- IV pentamidine.
- Trimethoprim > 200 mg/day.
- Nonsteroidal anti-inflammatory agents.
- Angiotensin converting enzyme inhibitors (benzapril, captopril, enalapril, fosinopril, lisinopril, guinapril, and ramipril) except for refractory hypertension.
- Concurrent Treatment:
- Excluded:
- Iodinated radiocontrast dye.
- Patients with the following prior conditions are excluded:
- Active pulmonary disease on chest radiograph within 60 days prior to study entry.
- CMV retinitis on ophthalmologic evaluation within 60 days prior to study entry.
- Positive blood culture for mycobacteria 10-60 days prior to study entry.
- Prior Medication:
- Excluded:
- Prior corticosteroid therapy for HIVAN.
- Corticosteroid therapy for any indication within 30 days prior to study entry.
- Continuous nonsteroidal anti-inflammatory agents for more than 15 days during the 4 weeks prior to study entry.
- Prior Treatment:
- Excluded within 30 days prior to study entry:
- Dialysis for acute or chronic renal failure.
- Iodinated radiocontrast dye.
- Required:
- Stable antiretroviral therapy with AZT alone or in combination with ddI, ddC, or d4T for at least 4 weeks unless contraindicated.
- PCP prophylaxis with TMP/SMX, pentamidine aerosol, dapsone, or atovaquone.
- MAC prophylaxis with rifabutin or clarithromycin for patients with CD4 count < 100 cells/mm3.
- Mycobacterium tuberculosis prophylaxis with isoniazid or another accepted regimen for patients with a positive or previously positive tuberculin test and for anergic patients who are known household or close contacts of infectious TB patients or who are from groups in which the prevalence of TB is 10 percent or higher.
- Investigational drugs unless exempted by protocol chair.
- Other medications unless expressly prohibited.
- Active alcohol or drug abuse.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, 21287
Case CRS
Cleveland, Ohio, 44106
MetroHealth CRS
Cleveland, Ohio, 44109
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
UCLA CARE Center CRS
Los Angeles, California, 90095
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003
Ucsf Aids Crs
San Francisco, California
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502
About this study
To determine the efficacy and safety of prednisone in patients with HIV-associated nephropathy. To determine the effects of prednisone on serum creatinine, urinary protein, and creatinine clearance.
HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in patients with advanced HIV disease. Little is known about the effects of corticosteroids on the progression of HIV disease. In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is warranted.
Read the detailed description
HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in patients with advanced HIV disease. Little is known about the effects of corticosteroids on the progression of HIV disease. In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is warranted.
Patients are randomized to receive prednisone or placebo for 11 weeks, followed by 13 weeks of observation.
- Conditions
- HIV Infections, AIDS-Associated Nephropathy
- Being tested
- Prednisone
- Keywords
- AIDS-Related Complex, Prednisone, AIDS-Associated Nephropathy
- Medical subject headings
- HIV Infections, AIDS-Associated Nephropathy, AIDS-Related Complex
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 completionSep 1996
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
- Enrolment
- 54 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Upjohn
- Responsible party
- Sponsor
- Investigators
- Kalayjian R, Study chairSmith MC, Study chairLederman M, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000819
- Sponsor's protocol ID
- ACTG 271
- Other IDs
- 11247
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
Publications
Kalayjian R, Phinney M, Austen J, Gripshover B, Carey J, Rahman M, Weigel K, Smith MC. Prednisone improves renal function in HIV-associated nephropathy (HIVAN). Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:154
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy of Prednisone Therapy in HIV-Associated Nephropathy (HIVAN)
- ClinicalTrials.gov ID
- NCT00000819
- Acronym / sponsor ID
- ACTG 271
- Conditions
- HIV Infections, AIDS-Associated Nephropathy
- Keywords
- AIDS-Related Complex, Prednisone, AIDS-Associated Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Upjohn
- Study completion
- Sep 1996 (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.
To determine the efficacy and safety of prednisone in patients with HIV-associated nephropathy. To determine the effects of prednisone on serum creatinine, urinary protein, and creatinine clearance.
HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in patients with advanced HIV disease. Little is known about the effects of corticosteroids on the progression of HIV disease. In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is warranted.
Detailed description
HIV-associated nephropathy is characterized by heavy proteinuria, rapidly progressive renal insufficiency, and distinct nephropathologic changes. The syndrome most often occurs in patients with advanced HIV disease. Little is known about the effects of corticosteroids on the progression of HIV disease. In light of the possible beneficial effects of corticosteroids on HIV-associated nephropathy, a controlled trial using prednisone is warranted.
Patients are randomized to receive prednisone or placebo for 11 weeks, followed by 13 weeks of observation.
Study design
- Primary purpose
- Treatment
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 infection.
- Biopsy-confirmed glomerulosclerosis and/or mesangial proliferation within 90 days prior to study entry.
- Mild to severe renal insufficiency that is stable or worsening.
- No AIDS-defining opportunistic infections or malignancies.
Key exclusion criteria (40 listed)
- Poorly controlled hypertension or diabetes mellitus.
- Peptic ulcer disease with gastrointestinal bleeding.
- Active symptomatic bacterial, protozoal, fungal, or viral infections (other than HIV disease).
- Superimposed renal disease that is due to processes other than focal glomerulosclerosis or mesangial proliferation, including but not limited to obstructive uropathy, acute tubular necrosis, and prerenal azotemia.
- Emotional problems sufficient to prevent adequate compliance with study therapy.
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 29 Oct 2021.
- BackgroundKalayjian R, Phinney M, Austen J, Gripshover B, Carey J, Rahman M, Weigel K, Smith MC. Prednisone improves renal function in HIV-associated nephropathy (HIVAN). Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:154
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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.
Kalayjian R study chair
Smith MC study chair
Lederman M study chair
8 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 and AIDS-Associated Nephropathy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 40 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 NCT00000819, 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 29 Oct 2021.