Severe Impairment of Solute-Free Water Clearance in Patients With HIV Infection

An observational study of HIV Infection, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of the present study is to analyze the overall tubular function, and in particular that from the proximal tubule and the thick ascending loop of Henle (TALH) in patients with HIV infection receiving or not tenofovir-containing antiretroviral treatment in comparison with seronegative controls, by applying… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV Infection
Type of treatment: Injection or infusion
How many people: 30 participants
Where: 1 siteArgentina
Study dates: Jan 2010to Apr 2012
Phase: Observational
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
Healthy volunteers accepted
Adult, Older adult

Study population: Patients with and without HIV infection followed at Hospital Italiano de Buenos Aires, university-affiliated tertiary-care community hospital

Who may be able to join

Inclusion criteria are as follows: adult patients (≥18 years old) with confirmed chronic HIV-1 infection who agreed to provide written informed consent. Patients under antiretroviral treatment must had a stable regimen for over six months and undetectable (<50 copies/ml) viral load for at least three months. At study entry all selected patients were confirmed as having normal physical examination, routine clinical laboratory including urinalysis, as well as renal and cardiac ultrasound.

Who cannot join

Exclusion criteria include patients with acute HIV infection (< 6 months of disease), personal history of nephropathy, plasma creatinine ≥1.3 mg/dl, Glomerular filtration rate ≤60ml/min/1.73 m² (as determined by Modification of Diet in renal Disease formula), presence of glucosuria/proteinuria (measured in spot urine sample), prior heart failure, concurrent opportunistic infection, chronic active hepatitis B or C, and use of potentially nephrotoxic agents in the prior week before the test (e.g diuretics, angiotensin converting enzyme antagonists, Angiotensin II receptor antagonists or non-steroidal anti-inflammatory agents).

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Hospital Italiano de Buenos Aires - Infectious Diseases Section
Buenos Aires, Buenos Aires F.D., 1181

Other trials in Argentina

About this study

Hypothesis is that patients with HIV infection and normal renal function will show subclinical tubular abnormalities compared with seronegative controls

Read the detailed description

Renal disease is a well recognized complication among patients with HIV infection. Either viral infection itself and the use of some antiretroviral drugs contribute to this serious non AIDS-defining condition that may affect both the glomeruli and the renal tubules.

The thick ascending loop of Henle constitutes the main location for free-water clearance determining kidney´s ability to concentrate and dilute urine in a direct and indirect fashion, respectively.

Conditions: HIV Infection
Being tested: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls
Keywords: HIV infection, Antiretroviral treatment, Renal disease, Renal tubular damage, Free-water clearance
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.

Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controlsOther
This test is based on the exploration of the tubular response to an acute fluid load. After overnight fast, all participants received twenty cc/Kg of mineralized water per os and two liters of intravenous hypotonic solution (0.66%) infused in two hours. Three blood samples are drawn (at 0, 60 and 120 minutes) and also urine samples are collected from each person at baseline and at 30 (±5) minutes intervals during the whole test. From the obtained blood and urine samples creatinine and osmolarity are measured, and then from the data corresponding to the most hypotonic urine sample (maximum dilution) and its corresponding blood sample three renal physiological parameters (proximal sodium clearance, free water clearance, sodium TALH reabsorption) are analyzed. Since patient inclusion follow up period is one month

Study groups in NCT01869010
Study group	Role	What they receive
HIV Tenofovir		Not described Receives: Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls
HIV No tenofovir		Not described Receives: Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls
Seronegative controls		Not described Receives: Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls

What is being measured

The primary outcome is the main question the study is designed to answer.

Free Water Clearance
Low sodium water overload
Measured: 1 month

Secondary outcomes (1)

Urine osmolarity
Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Apr 2012

First posted5 Jun 2013 (estimated)
Study startJan 2010
Primary completionMar 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies of the same condition, open and under way.
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: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01869010
Sponsor's protocol ID: 1237
Status last verified: Feb 2018
First submitted: 29 May 2013
Last updated: 9 Sep 2025
Results posted: No
Data monitoring committee: No

Publications

Phair J, Palella F. Renal disease in HIV-infected individuals. Curr Opin HIV AIDS. 2011 Jul;6(4):285-9. doi: 10.1097/COH.0b013e3283476bc3.
PubMed 21519246
Estrella MM, Fine DM, Atta MG. Recent developments in HIV-related kidney disease. HIV Ther. 2010 Sep;4(5):589-603. doi: 10.2217/hiv.10.42.
PubMed 21331321
Mathew G, Knaus SJ. Acquired Fanconi's syndrome associated with tenofovir therapy. J Gen Intern Med. 2006 Nov;21(11):C3-5. doi: 10.1111/j.1525-1497.2006.00518.x.
PubMed 17026723
Fernandez-Fernandez B, Montoya-Ferrer A, Sanz AB, Sanchez-Nino MD, Izquierdo MC, Poveda J, Sainz-Prestel V, Ortiz-Martin N, Parra-Rodriguez A, Selgas R, Ruiz-Ortega M, Egido J, Ortiz A. Tenofovir nephrotoxicity: 2011 update. AIDS Res Treat. 2011;2011:354908. doi: 10.1155/2011/354908. Epub 2011 Jun 7.
PubMed 21716719
Rodriguez-Novoa S, Alvarez E, Labarga P, Soriano V. Renal toxicity associated with tenofovir use. Expert Opin Drug Saf. 2010 Jul;9(4):545-59. doi: 10.1517/14740331003627458.
PubMed 20384533
Cooper RD, Wiebe N, Smith N, Keiser P, Naicker S, Tonelli M. Systematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIV-infected patients. Clin Infect Dis. 2010 Sep 1;51(5):496-505. doi: 10.1086/655681.
PubMed 20673002
Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
PubMed 15385656
Choi AI, Li Y, Deeks SG, Grunfeld C, Volberding PA, Shlipak MG. Association between kidney function and albuminuria with cardiovascular events in HIV-infected persons. Circulation. 2010 Feb 9;121(5):651-8. doi: 10.1161/CIRCULATIONAHA.109.898585. Epub 2010 Jan 25.
PubMed 20100969
Gupta SK, Smurzynski M, Franceschini N, Bosch RJ, Szczech LA, Kalayjian RC; AIDS Clinical Trials Group Longitudinal Linked Randomized Trials Study Team. The effects of HIV type-1 viral suppression and non-viral factors on quantitative proteinuria in the highly active antiretroviral therapy era. Antivir Ther. 2009;14(4):543-9.
PubMed 19578239
Kalayjian RC. Kidney Disease in HIV-Infected Persons. Curr Infect Dis Rep. 2012 Feb;14(1):83-90. doi: 10.1007/s11908-011-0228-2.
PubMed 22190152
Kalayjian RC. Renal issues in HIV infection. Curr HIV/AIDS Rep. 2011 Sep;8(3):164-71. doi: 10.1007/s11904-011-0080-x.
PubMed 21643783
Szczech LA. Renal dysfunction and tenofovir toxicity in HIV-infected patients. Top HIV Med. 2008 Oct-Nov;16(4):122-6.
PubMed 18838746
Vrouenraets SM, Fux CA, Wit FW, Garcia EF, Furrer H, Brinkman K, Hoek FJ, Abeling NG, Krediet RT, Reiss P; Prepare Study Group. Persistent decline in estimated but not measured glomerular filtration rate on tenofovir may reflect tubular rather than glomerular toxicity. AIDS. 2011 Nov 13;25(17):2149-55. doi: 10.1097/QAD.0b013e32834bba87.
PubMed 21857491
Hall AM, Edwards SG, Lapsley M, Connolly JO, Chetty K, O'Farrell S, Unwin RJ, Williams IG. Subclinical tubular injury in HIV-infected individuals on antiretroviral therapy: a cross-sectional analysis. Am J Kidney Dis. 2009 Dec;54(6):1034-42. doi: 10.1053/j.ajkd.2009.07.012. Epub 2009 Sep 23.
PubMed 19783343
Labarga P, Barreiro P, Martin-Carbonero L, Rodriguez-Novoa S, Solera C, Medrano J, Rivas P, Albalater M, Blanco F, Moreno V, Vispo E, Soriano V. Kidney tubular abnormalities in the absence of impaired glomerular function in HIV patients treated with tenofovir. AIDS. 2009 Mar 27;23(6):689-96. doi: 10.1097/QAD.0b013e3283262a64.
PubMed 19262355

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Severe Impairment of Solute-Free Water Clearance in Patients With HIV Infection
ClinicalTrials.gov ID: NCT01869010
Acronym / sponsor ID: 1237
Conditions: HIV Infection
Keywords: HIV infection, Antiretroviral treatment, Renal disease, Renal tubular damage, Free-water clearance
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Hospital Italiano de Buenos AiresUniversity, hospital or other
Study start: Jan 2010
Primary completion: Mar 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 5 Jun 2013 (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.

Hypothesis is that patients with HIV infection and normal renal function will show subclinical tubular abnormalities compared with seronegative controls

Detailed description

The thick ascending loop of Henle constitutes the main location for free-water clearance determining kidney´s ability to concentrate and dilute urine in a direct and indirect fashion, respectively.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
HIV Tenofovir	–	Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls
HIV No tenofovir	–	Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls
Seronegative controls	–	Other: Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Patients with and without HIV infection followed at Hospital Italiano de Buenos Aires, university-affiliated tertiary-care community hospital

Key inclusion criteria (1 listed)

Inclusion criteria are as follows: adult patients (≥18 years old) with confirmed chronic HIV-1 infection who agreed to provide written informed consent. Patients under antiretroviral treatment must had a stable regimen for over six months and undetectable (<50 copies/ml) viral load for at least three months. At study entry all selected patients were confirmed as having normal physical examination, routine clinical laboratory including urinalysis, as well as renal and cardiac ultrasound.

Key exclusion criteria (1 listed)

Exclusion criteria include patients with acute HIV infection (< 6 months of disease), personal history of nephropathy, plasma creatinine ≥1.3 mg/dl, Glomerular filtration rate ≤60ml/min/1.73 m² (as determined by Modification of Diet in renal Disease formula), presence of glucosuria/proteinuria (measured in spot urine sample), prior heart failure, concurrent opportunistic infection, chronic active hepatitis B or C, and use of potentially nephrotoxic agents in the prior week before the test (e.g diuretics, angiotensin converting enzyme antagonists, Angiotensin II receptor antagonists or non-steroidal anti-inflammatory agents).

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
Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controlsThis test is based on the exploration of the tubular response to an acute fluid load. After overnight fast, all participants received twenty cc/Kg of mineralized water per os and two liters of intravenous hypotonic solution (0.66%) infused in two hours. Three blood samples are drawn (at 0, 60 and 120 minutes) and also urine samples are collected from each person at baseline and at 30 (±5) minutes intervals during the whole test. From the obtained blood and urine samples creatinine and osmolarity are measured, and then from the data corresponding to the most hypotonic urine sample (maximum dilution) and its corresponding blood sample three renal physiological parameters (proximal sodium clearance, free water clearance, sodium TALH reabsorption) are analyzed. Since patient inclusion follow up period is one month	Other	HIV No tenofovir, HIV Tenofovir, Seronegative controls

Primary outcome

Free Water Clearance
Time frame: 1 month
Low sodium water overload

1 secondary outcome

Urine osmolarity
Time frame: one month

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 9 Sep 2025.
Background: PubMed 21519246Phair J, Palella F. Renal disease in HIV-infected individuals. Curr Opin HIV AIDS. 2011 Jul;6(4):285-9. doi: 10.1097/COH.0b013e3283476bc3.
Background: PubMed 21331321Estrella MM, Fine DM, Atta MG. Recent developments in HIV-related kidney disease. HIV Ther. 2010 Sep;4(5):589-603. doi: 10.2217/hiv.10.42.
Background: PubMed 17026723Mathew G, Knaus SJ. Acquired Fanconi's syndrome associated with tenofovir therapy. J Gen Intern Med. 2006 Nov;21(11):C3-5. doi: 10.1111/j.1525-1497.2006.00518.x.
Background: PubMed 21716719Fernandez-Fernandez B, Montoya-Ferrer A, Sanz AB, Sanchez-Nino MD, Izquierdo MC, Poveda J, Sainz-Prestel V, Ortiz-Martin N, Parra-Rodriguez A, Selgas R, Ruiz-Ortega M, Egido J, Ortiz A. Tenofovir nephrotoxicity: 2011 update. AIDS Res Treat. 2011;2011:354908. doi: 10.1155/2011/354908. Epub 2011 Jun 7.
Background: PubMed 20384533Rodriguez-Novoa S, Alvarez E, Labarga P, Soriano V. Renal toxicity associated with tenofovir use. Expert Opin Drug Saf. 2010 Jul;9(4):545-59. doi: 10.1517/14740331003627458.
Background: PubMed 20673002Cooper RD, Wiebe N, Smith N, Keiser P, Naicker S, Tonelli M. Systematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIV-infected patients. Clin Infect Dis. 2010 Sep 1;51(5):496-505. doi: 10.1086/655681.
Background: PubMed 15385656Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.
Background: PubMed 20100969Choi AI, Li Y, Deeks SG, Grunfeld C, Volberding PA, Shlipak MG. Association between kidney function and albuminuria with cardiovascular events in HIV-infected persons. Circulation. 2010 Feb 9;121(5):651-8. doi: 10.1161/CIRCULATIONAHA.109.898585. Epub 2010 Jan 25.
Background: PubMed 19578239Gupta SK, Smurzynski M, Franceschini N, Bosch RJ, Szczech LA, Kalayjian RC; AIDS Clinical Trials Group Longitudinal Linked Randomized Trials Study Team. The effects of HIV type-1 viral suppression and non-viral factors on quantitative proteinuria in the highly active antiretroviral therapy era. Antivir Ther. 2009;14(4):543-9.
Background: PubMed 22190152Kalayjian RC. Kidney Disease in HIV-Infected Persons. Curr Infect Dis Rep. 2012 Feb;14(1):83-90. doi: 10.1007/s11908-011-0228-2.
Background: PubMed 21643783Kalayjian RC. Renal issues in HIV infection. Curr HIV/AIDS Rep. 2011 Sep;8(3):164-71. doi: 10.1007/s11904-011-0080-x.
Background: PubMed 18838746Szczech LA. Renal dysfunction and tenofovir toxicity in HIV-infected patients. Top HIV Med. 2008 Oct-Nov;16(4):122-6.

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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.

Waldo H Belloso, MD principal investigator

Hospital Italiano de Buenos Aires

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

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 1 inclusion and 1 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 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. 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.

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.

What does the primary outcome measure?

Free Water Clearance (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01869010, which also lists 22 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 Sep 2025.