HIV InfectionsPhase 3NCT00089518
Optimal Treatment for Kidney Disease in HIV Infected Adults
A Phase 3 study testing Valsartan in people with HIV Infections and Kidney Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial summary
The angiotensin receptor blocker (ARB) valsartan is a drug commonly used to treat high blood pressure. Valsartan may also help slow down the progression of kidney disease in HIV infected people. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Kidney Disease
- What is being tested?
- Valsartan
- How many people
- 0 participants
- Where
- 10 sitesUnited States
- Study dates
- Start not givento not given
- 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 infected
- Evidence of HIV-associated nephropathy by kidney biopsy performed locally within 24 weeks prior to study entry
- On ART for at least 42 days prior to study entry and willing to continue ART while on study
- Systolic blood pressure (BP) between 91 mm Hg and 170 mm Hg and diastolic BP 105 mm Hg or less within 24 hours of study entry
- Stable kidney function, as indicated by two consecutive calculated creatinine clearance measurements higher than 30 ml/min
- Serum potassium of less than Grade 1 within 7 days prior to study entry
- Willing to follow dose adjustments of non-study antihypertensive drugs if necessary
- Willing to use acceptable forms of contraception
Who cannot join
- Current treatment with hemodialysis or peritoneal dialysis
- History of kidney transplant
- Condition other than HIVAN contributing to decreased kidney function
- ALT or AST greater than 5 times the upper limit of normal (ULN) within 28 days of study entry
- Total bilirubin greater than 2.5 times ULN within 28 days of study entry. Patients with total bilirubin between 2.5 times and 5 times ULN who are receiving indinavir or atazanavir and do not have cirrhosis or severe liver disease are not excluded.
- Current heart indication for an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
Show all 18Show fewer
- Use of an ACEI or ARB within 7 days prior to first creatinine clearance measurement obtained for screening or any time between screening and study entry
- Systemic steroid therapy above a replacement level within 28 days of study entry, or possible need for ongoing systemic steroid therapy above replacement level during the study
- Current use of cimetidine
- Use of investigational agents, except when approved by the protocol chairs
- Allergy or sensitivity to valsartan or its formulations
- Blood pressure not measurable by the technique described in the protocol
- Orthostatic drop in systolic BP of 30 mm Hg or more within 24 hours prior to study entry
- Drug or alcohol use that, in the opinion of the investigator, would interfere with the study
- Decreased mental capacity that, in the opinion of the investigator, would interfere with the study
- AIDS-defining opportunistic infection (OI) within 28 days prior to study entry. Patients who are receiving maintenance therapy for OIs and have no evidence of active disease are not excluded.
- Diabetes mellitus for 2 years or longer prior to study entry. Onset of diabetes is defined as the point at which patients began oral hypoglycemics or insulin.
- Pregnancy or breastfeeding
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998
Duke University Medical Center
Durham, North Carolina, 27710
Indiana University Hospital
Indianapolis, Indiana, 46202-5250
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202-5250
Wishard Hospital
Indianapolis, Indiana, 46202
NYU/Bellevue
New York, New York, 10016-6481
Rhode Island Hospital
Providence, Rhode Island, 02906
Stanley Street Treatment and Resource
Providence, Rhode Island, 02906
The Miriam Hospital
Providence, Rhode Island, 02906
Washington University (St. Louis)
St Louis, Missouri, 63108-2138
About this study
Official title: A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial of an Angiotensin Receptor Blocker (Valsartan) and Highly Active Antiretroviral Therapy (HAART) Versus HAART Alone for the Treatment of HIV-Associated Nephropathy
The angiotensin receptor blocker (ARB) valsartan is a drug commonly used to treat high blood pressure. Valsartan may also help slow down the progression of kidney disease in HIV infected people. The purpose of this study is to compare valsartan and antiretroviral therapy (ART) to ART alone in slowing kidney disease progression in people with HIV.
Read the detailed description
ART for the treatment of HIV may slow the progression of HIV-associated nephropathy (HIVAN) to end-stage renal disease (ESRD); nevertheless, it is predicted that many HIV infected patients on ART will reach ESRD by the next decade. Medications that affect the renin-angiotensin system, such as the ARB valsartan, may be useful in treating HIVAN. In a small study of HIV infected patients with HIVAN treated with the angiotensin-converting enzyme inhibitor (ACEI) fosinopril, kidney function was stable in patients who took the ACEI, but function decreased in patients who did not. These data are promising, and suggest that an ARB like valsartan may also slow the progression of HIVAN and improve patients' prognosis. This study will compare valsartan and ART to ART alone in slowing kidney disease progression in people with HIV.
This study will last 96 weeks. All participants will continue taking their current ART regimen during the study and will be randomly assigned to one of two arms: Arm 1 will receive valsartan daily, while Arm 2 will receive placebo daily. Doses of drug or placebo may be adjusted during the first 8 weeks based on blood pressure readings taken during the study. In addition, if patients are on other antihypertensive drugs, dosage adjustments may be necessary for those drugs during the study. No ART or antihypertensive drugs other than valsartan will be provided by the study. Study visits will occur every week until Week 8, then every 8 weeks until the end of the study at Week 96. Study visits will include physical examination, medication assessment, and blood pressure readings. In addition, blood collection will occur at entry, Weeks 2, 4, 6, and 8, and every 8 weeks thereafter.
- Conditions
- HIV Infections, Kidney Disease
- Being tested
- Valsartan
- Keywords
- Treatment Experienced
- Medical subject headings
- HIV Infections, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2004 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Lynda Anne Szczech, MD, MSCE, Study chair, Division of Nephrology, Department of Medicine, Duke University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089518
- Sponsor's protocol ID
- ACTG A5179
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2004
- Last updated
- 9 Mar 2015
- Results posted
- No
Publications
Herman ES, Klotman PE. HIV-associated nephropathy: Epidemiology, pathogenesis, and treatment. Semin Nephrol. 2003 Mar;23(2):200-8. doi: 10.1053/snep.2003.50018.
PubMed 12704580Kimmel PL, Barisoni L, Kopp JB. Pathogenesis and treatment of HIV-associated renal diseases: lessons from clinical and animal studies, molecular pathologic correlations, and genetic investigations. Ann Intern Med. 2003 Aug 5;139(3):214-26.
PubMed 12899589Marras D, Bruggeman LA, Gao F, Tanji N, Mansukhani MM, Cara A, Ross MD, Gusella GL, Benson G, D'Agati VD, Hahn BH, Klotman ME, Klotman PE. Replication and compartmentalization of HIV-1 in kidney epithelium of patients with HIV-associated nephropathy. Nat Med. 2002 May;8(5):522-6. doi: 10.1038/nm0502-522.
PubMed 11984599Wei A, Burns GC, Williams BA, Mohammed NB, Visintainer P, Sivak SL. Long-term renal survival in HIV-associated nephropathy with angiotensin-converting enzyme inhibition. Kidney Int. 2003 Oct;64(4):1462-71. doi: 10.1046/j.1523-1755.2003.00230.x.
PubMed 12969167
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Placebo-Controlled, Double-Blind Trial of an Angiotensin Receptor Blocker (Valsartan) and Highly Active Antiretroviral Therapy (HAART) Versus HAART Alone for the Treatment of HIV-Associated Nephropathy
- ClinicalTrials.gov ID
- NCT00089518
- Acronym / sponsor ID
- ACTG A5179
- Conditions
- HIV Infections, Kidney Disease
- Keywords
- Treatment Experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 6 Aug 2004 (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 angiotensin receptor blocker (ARB) valsartan is a drug commonly used to treat high blood pressure. Valsartan may also help slow down the progression of kidney disease in HIV infected people. The purpose of this study is to compare valsartan and antiretroviral therapy (ART) to ART alone in slowing kidney disease progression in people with HIV.
Detailed description
ART for the treatment of HIV may slow the progression of HIV-associated nephropathy (HIVAN) to end-stage renal disease (ESRD); nevertheless, it is predicted that many HIV infected patients on ART will reach ESRD by the next decade. Medications that affect the renin-angiotensin system, such as the ARB valsartan, may be useful in treating HIVAN. In a small study of HIV infected patients with HIVAN treated with the angiotensin-converting enzyme inhibitor (ACEI) fosinopril, kidney function was stable in patients who took the ACEI, but function decreased in patients who did not. These data are promising, and suggest that an ARB like valsartan may also slow the progression of HIVAN and improve patients' prognosis. This study will compare valsartan and ART to ART alone in slowing kidney disease progression in people with HIV.
This study will last 96 weeks. All participants will continue taking their current ART regimen during the study and will be randomly assigned to one of two arms: Arm 1 will receive valsartan daily, while Arm 2 will receive placebo daily. Doses of drug or placebo may be adjusted during the first 8 weeks based on blood pressure readings taken during the study. In addition, if patients are on other antihypertensive drugs, dosage adjustments may be necessary for those drugs during the study. No ART or antihypertensive drugs other than valsartan will be provided by the study. Study visits will occur every week until Week 8, then every 8 weeks until the end of the study at Week 96. Study visits will include physical examination, medication assessment, and blood pressure readings. In addition, blood collection will occur at entry, Weeks 2, 4, 6, and 8, and every 8 weeks thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (8 listed)
- HIV infected
- Evidence of HIV-associated nephropathy by kidney biopsy performed locally within 24 weeks prior to study entry
- On ART for at least 42 days prior to study entry and willing to continue ART while on study
- Systolic blood pressure (BP) between 91 mm Hg and 170 mm Hg and diastolic BP 105 mm Hg or less within 24 hours of study entry
- Stable kidney function, as indicated by two consecutive calculated creatinine clearance measurements higher than 30 ml/min
Key exclusion criteria (18 listed)
- Current treatment with hemodialysis or peritoneal dialysis
- History of kidney transplant
- Condition other than HIVAN contributing to decreased kidney function
- ALT or AST greater than 5 times the upper limit of normal (ULN) within 28 days of study entry
- Total bilirubin greater than 2.5 times ULN within 28 days of study entry. Patients with total bilirubin between 2.5 times and 5 times ULN who are receiving indinavir or atazanavir and do not have cirrhosis or severe liver disease are not excluded.
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 |
|---|---|---|
| Valsartan | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
- Background: PubMed 12704580Herman ES, Klotman PE. HIV-associated nephropathy: Epidemiology, pathogenesis, and treatment. Semin Nephrol. 2003 Mar;23(2):200-8. doi: 10.1053/snep.2003.50018.
- Background: PubMed 12899589Kimmel PL, Barisoni L, Kopp JB. Pathogenesis and treatment of HIV-associated renal diseases: lessons from clinical and animal studies, molecular pathologic correlations, and genetic investigations. Ann Intern Med. 2003 Aug 5;139(3):214-26.
- Background: PubMed 11984599Marras D, Bruggeman LA, Gao F, Tanji N, Mansukhani MM, Cara A, Ross MD, Gusella GL, Benson G, D'Agati VD, Hahn BH, Klotman ME, Klotman PE. Replication and compartmentalization of HIV-1 in kidney epithelium of patients with HIV-associated nephropathy. Nat Med. 2002 May;8(5):522-6. doi: 10.1038/nm0502-522.
- Background: PubMed 12969167Wei A, Burns GC, Williams BA, Mohammed NB, Visintainer P, Sivak SL. Long-term renal survival in HIV-associated nephropathy with angiotensin-converting enzyme inhibition. Kidney Int. 2003 Oct;64(4):1462-71. doi: 10.1046/j.1523-1755.2003.00230.x.
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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.
Lynda Anne Szczech, MD, MSCE study chair
Division of Nephrology, Department of Medicine, Duke University Medical Center
10 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 Valsartan in people with HIV Infections and Kidney Disease, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 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 8 inclusion and 18 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: withdrawn, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 was withdrawn before enrolling participants, so there are no results.
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 NCT00089518, which also lists 4 linked publications.
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 9 Mar 2015.