HIV-1 InfectionPhase 2NCT01543958
Sevelamer for Reducing Endotoxemia and Immune Activation
A Phase 2 study testing Sevelamer carbonate in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 15 sites in United States.
Trial summary
HIV-infected people can have an increase in inflammation in their body organs, even after taking anti-HIV medicines. Sevelamer carbonate is used to bind phosphate in dialysis patients. It can also bind endotoxin in the gut and lowers endotoxin levels in the blood of dialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Sevelamer carbonate
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 15 sitesUnited States
- Study dates
- Nov 2011to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No plans to initiate ART during the course of the proposed study.
- Screening CD4+ T-cell count ≥ 400 cells/mm3 performed in a laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent.
- HIV-1 RNA >50 copies/mL within the last 180 days prior to entry.
- Screening serum phosphate > 2.6 mg/dL within 60 days prior to entry.
- Certain laboratory values, as detailed in section 4.1.6 of the protocol, obtained within 30 days prior to entry
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- Female subjects of reproductive potential must have a negative serum or urine pregnancy test performed within 30 days prior to entry.
- Female subjects participating in sexual activity that could lead to pregnancy must agree to use at least one of the following forms of birth control for at least 30 days prior to study entry until the final study visit:
- Condoms (male or female) with or without a spermicidal agent
- Diaphragm or cervical cap with spermicide
- Intrauterine device (IUD)
- Hormone-based contraceptive
- Female subjects who are not of reproductive potential are eligible without requiring the use of a contraceptive.
- Confirmation of the availability of the stored pre-entry plasma and peripheral blood mononuclear cell (PBMC) samples for endotoxin, sCD14, and immune activation determinations, obtained from a fasting sample.
- Ability and willingness of subject to provide informed consent.
- No plans to use probiotics (defined as products that contain significant amounts of live microorganisms and are ingested for specific health benefits, e.g., yogurt with live and active cultures, Lactobacillus GG, Saccharomyces boulardii) during the study.
Who cannot join
- Known diagnosis of acute HIV infection within 180 days prior to study entry.
- Pregnant or breastfeeding.
- Use of any antiretroviral agent within 24 weeks prior to study entry.
- Use of systemic cancer chemotherapy or radiation therapy, immunosuppressive or immunomodulatory therapy (e.g., interferons, tumor necrosis factor antagonists, interleukins, systemic corticosteroids) within 24 weeks prior to study entry.
- NOTE A: Use of inhaled steroids, nasal steroids, topical steroids, or the equivalent of 10 mg of prednisone or less per day or a less than 2-week course of oral steroids is not exclusionary.
- NOTE B: A single course of 1% hydrocortisone cream applied up to 3 times a day to <10 square inches area for <2 weeks is permitted while on study. Use of all other topical steroids is excluded.
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- Known allergy/sensitivity or any hypersensitivity to components of the study drug or its formulation.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Serious illness requiring systemic treatment and/or hospitalization within 60 days prior to study entry.
- Known cirrhosis or severe liver disease (e.g., ascites, encephalopathy, history of variceal bleeding).
- NOTE: Potential subjects with chronic hepatitis B or C virus infection who do not have known cirrhosis or severe liver disease may participate in the study.
- Severe kidney disease (defined as estimated glomerular filtration rate [GFR] <30 mL/min/1.73m2) at screening.
- History of bowel obstruction or severe GI motility disorders including severe constipation.
- Severe dysphagia or swallowing disorders.
- Major GI tract surgery within 60 days prior to study entry.
- Intent to initiate or change the dose of lipid-lowering drugs during study. NOTE: Potential subjects on stable doses of lipid-lowering agents (defined as no change in preparation or dose within 90 days prior to study entry) are permitted and may be enrolled.
- Use of investigational therapies within 90 days prior to study entry unless permission was granted by the A5296 protocol chairs (see Study Management page).
- Currently receiving hepatitis C therapy or anticipation that such therapy will be started during the study.
- Use of probiotics, for more than 3 consecutive days within the 60 days prior to study entry.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Colorado Hospital CRS (6101)
Aurora, Colorado, 80045
Alabama Therapeutics CRS (5801)
Birmingham, Alabama, 35294
Massachusetts General Hospital ACTG CRS (101)
Boston, Massachusetts, 02114
Northwestern University CRS (2701)
Chicago, Illinois, 60611
Univ. of Cincinnati CRS (2401)
Cincinnati, Ohio, 45267
Case CRS (2501)
Cleveland, Ohio, 44106
Metro Health CRS (2503)
Cleveland, Ohio, 44109
UCLA CARE Center CRS (601)
Los Angeles, California, 90095
Univ. of Miami AIDS CRS (901)
Miami, Florida, 33136
Hosp. of the Univ. of Pennsylvania CRS (6201)
Philadelphia, Pennsylvania, 19104
AIDS Care CRS (1108)
Rochester, New York, 14642
Univ. of Rochester ACTG CRS (1101)
Rochester, New York, 14642
Ucsf Aids Crs (801)
San Francisco, California, 94110
Washington University CRS (2101)
St Louis, Missouri, 63110
Harbor-UCLA Med. Ctr. CRS (603)
Torrance, California, 90502
About this study
Official title: Sevelamer Carbonate for Reducing Endotoxemia and Immune Activation: A Proof of Concept Study
HIV-infected people can have an increase in inflammation in their body organs, even after taking anti-HIV medicines.
Sevelamer carbonate is used to bind phosphate in dialysis patients. It can also bind endotoxin in the gut and lowers endotoxin levels in the blood of dialysis patients. Sevelamer carbonate decreases the inflammation endotoxin causes in dialysis patients.
A5296 is a phase II, single-arm study to evaluate the effect of 8 weeks of sevelamer carbonate administration on markers of microbial translocation and T-cell activation in the blood in chronically HIV-infected subjects not receiving ART.
Read the detailed description
HIV-infected people can have an increase in inflammation in their body organs, even after taking anti-HIV medicines. Inflammation is a normal body reaction to any infection. However, if inflammation lasts a long time like in HIV infection, it may lead to complications, such as heart disease, cancer, liver disease, and problems with thinking. Also, HIV-infected people with high inflammation have lower CD4+ T-cell counts (cells that fight infection). Many HIV researchers are studying the harmful effects of this prolonged inflammation and possible ways to prevent these complications.
The increase in inflammation in HIV-infected people may be caused by HIV or by other factors such as parts of bacteria. These bacterial pieces, called endotoxins, do not cause harm in the intestine (gut). However, in HIV infection, there is damage to the gut that allows endotoxins to cross from the gut into the blood. These endotoxins then cause inflammation in the body. New research is focusing on strategies to reduce the levels of endotoxin as a way to decrease inflammation.
A drug called sevelamer carbonate is used to bind phosphate in dialysis patients. However, sevelamer carbonate also binds endotoxin in the gut and lowers endotoxin levels in the blood of dialysis patients. Sevelamer carbonate also decreases the inflammation endotoxin causes in dialysis patients. This study will see if sevelamer carbonate can have the same effects in HIV-infected patients.
A5296 is a phase II, single-arm study to evaluate the effect of 8 weeks of sevelamer carbonate administration on markers of microbial translocation as well as monocyte and T-cell activation in the blood in chronically HIV-infected subjects with CD4+ T-cell count ≥ 400 cells/mm3 not receiving ART. This study enrolled 40 subjects. To assess whether there is a persistent effect of study drug, subjects were observed for an additional 8 weeks off sevelamer carbonate and changes in biomarkers were monitored.
As A5296 is a phase II study of biologic activity, the primary and secondary analyses are as-treated, limited to subjects who have data for baseline and week 8 and who remain on study treatment through week 8. For any subject who initiated antiretroviral treatment (ART), analyses only included data collected prior to the time ART was started.
- Conditions
- HIV-1 Infection
- Being tested
- Sevelamer carbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevelamer carbonateDrug
Also called Renvela
Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
Sevelamer carbonateDevice
Also called Renvela
| Study group | Role | What they receive |
|---|---|---|
| Sevelamer carbonate | Experimental | Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. Receives: Drug: Sevelamer carbonate; Device: Sevelamer carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endotoxin
Change in LPS from baseline to week 8, where baseline value is the average of pre-entry and entry values.
Measured: baseline and Week 8
Change in Soluble CD14 (sCD14)
Change in soluble CD14 (sCD14) from baseline to week 8, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Secondary outcomes (48)
Change in Endotoxin
Change in endotoxin from baseline to week 4, where baseline value is the average of pre-entry and entry
Measured: baseline and week 4
Change in Endotoxin
Change in endotoxin from week 8 to week 16
Measured: week 8 and week 16
Change in sCD14
Change in sCD14 from baseline to week 4, where baseline value is the average of pre-entry and entry
Measured: baseline and week 4
Change in sCD14
Change in sCD14 from week 8 to week 16
Measured: week 8 and week 16
Change in CD4+ T-cell Activation
Change from baseline to week 8 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Change in CD4+ T-cell Activation
Change from baseline to week 4 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry
Measured: baseline and week 4
Change in CD4+ T-cell Activation
Change from week 8 to week 16 in CD4+ T-cell activation, defined as the %CD38+/HLA-DR+
Measured: week 8 and week 16
Change in CD8+ T-cell Activation
Change from baseline to week 4 in CD8+ T-cell activation, defined as the %CD38+/HLA-DR+, where baseline value is the average of pre-entry and entry
Measured: baseline and week 4
Change in CD8+ T-cell Activation
Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from baseline to week 8, where baseline is the average of pre-entry and entry
Measured: Baseline and Week 8
Change in CD8+ T-cell Activation
Change in CD8+ T-cell activation defined as the %CD38+/HLA-DR+ from week 8 to week 16
Measured: week 8 and week 16
Change in Proportion of Cycling CD8+
Change from baseline to week 4 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry
Measured: baseline and week 4
Change in Proportion of Cycling CD8+
Change from baseline to week 8 in cycling CD8+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Change in Proportion of Cycling CD8+
Change from week 8 to week 16 in cycling CD8+ , defined as the %Ki67+
Measured: from week 8 to week 16
Change in Proportion of Cycling CD4+
Change from baseline to week 4 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry
Measured: baseline and week 4
Change in Proportion of Cycling CD4+
Change from baseline to week 8 in cycling CD4+ , defined as the %Ki67+, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Change in Proportion of Cycling CD4+
Change from week 8 to week 16 in cycling CD4+ , defined as the %Ki67+
Measured: week 8 and week 16
Change in Blood Phosphate Levels
Change in blood phosphate levels from baseline to week 4, where baseline value is the average of pre-entry and entry
Measured: from baseline to week 4
Change in Blood Phosphate Levels
Change in blood phosphate levels from baseline to week 8
Measured: Baseline to Week 8
Change in Blood Phosphate Levels
Change in blood phosphate levels from week 8 to week 16
Measured: from week 8 to week 16
Change in log10 HIV RNA Levels
Change in log10 HIV RNA levels from baseline to week 4, where baseline value is the average of pre-entry and entry
Measured: baseline and week 4
Change in log10 HIV RNA Levels
Change in log10 HIV RNA levels from baseline to week 8, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Change in log10 HIV RNA Levels
Change in log10 HIV RNA levels from week 8 to week 16
Measured: week 8 and week 16
Change in CD4+ T-cell Counts
Change in CD4+ T-cell counts from baseline to week 4, where baseline is the average of pre-entry and entry
Measured: baseline and week 4
Change in CD4+ T-cell Counts
Change in CD4+ T-cell counts from baseline to week 8, where baseline is the average of pre-entry and entry
Measured: baseline and week 8
Change in CD4+ T-cell Counts
Change in CD4+ T-cell counts from week 8 to week 16
Measured: week 8 and week 16
Change in IL-6
Changes in levels of systemic inflammation marker IL-6 from baseline to week 4, where baseline is the average of pre-entry and entry
Measured: baseline and week 4
Change in IL-6
Changes in levels of systemic inflammation marker IL-6 from baseline to week 8, where baseline is the average of pre-entry and entry
Measured: baseline and week 8
Change in IL-6
Changes in levels of systemic inflammation marker IL-6 from week 8 to week 16
Measured: week 8 and week 16
Change in C-reactive Protein (CRP)
Changes in levels of systemic inflammation marker CRP from baseline to week 4, where baseline is the average of pre-entry and entry
Measured: baseline and week 4
Change in CRP
Changes in levels of systemic inflammation marker CRP from baseline to week 8, where baseline is the average of pre-entry and entry
Measured: Baseline and Week 8
Change in CRP
Changes in levels of systemic inflammation marker CRP from week 8 to week 16, where baseline is the average of pre-entry and entry
Measured: week 8 and week 16
Change in D-dimer
Change in levels of coagulation biomarker d-dimer from baseline to week 4, where baseline value is the average of pre-entry and entry
Measured: baseline and week 4
Change in D-dimer
Change in levels of coagulation biomarker d-dimer from baseline to week 8, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Change in D-dimer
Change in levels of coagulation biomarker d-dimer from week 8 to week 16
Measured: week 8 and week 16
Change in Tissue Factor
Change in levels of coagulation biomarker tissue factor from baseline to week 4, where baseline value is the average of pre-entry and entry
Measured: baseline and week 4
Change in Tissue Factor
Change in levels of coagulation biomarker tissue factor from baseline to week 8, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Change in Tissue Factor
Change in levels of coagulation biomarker tissue factor from week 8 to week 16
Measured: week 8 and week 16
Change in Total Cholesterol
Change in total cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Change in Total Cholesterol
Change in total cholesterol from week 8 to week 16
Measured: week 8 and week 16
Change in LDL Cholesterol
Change in fasting LDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Change in LDL Cholesterol
Change in fasting LDL cholesterol from week 8 to week 16
Measured: week 8 and week 16
Change in HDL Cholesterol
Change in fasting HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Change in HDL Cholesterol
Change in fasting HDL cholesterol from week 8 to week 16
Measured: from week 8 to week 16
Change in Non-HDL Cholesterol
Change in non-HDL cholesterol from baseline to week 8, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Change in Non-HDL Cholesterol
Change in non-HDL cholesterol from week 8 to week 16
Measured: week 8 and week 16
Change in Fasting Glucose
Change in fasting glucose from baseline to week 8, where baseline value is the average of pre-entry and entry
Measured: baseline and week 8
Change in Fasting Glucose
Change in fasting glucose from week 8 to week 16
Measured: week 8 and week 16
Primary Adverse Events
Number of subjects experiencing primary adverse events, defined as all reported Grade ≥ 2 signs and symptoms, Grade ≥ 2 laboratory abnormalities and other serious adverse events (SAEs)
Measured: baseline and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rajesh Gandhi, MD, Study chair, Massachusetts General Hospital ACTG CRSNetanya Sandler, MD, Study chair, National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543958
- Sponsor's protocol ID
- ACTG A5296
- Other IDs
- 1U01AI068636
- Status last verified
- Sep 2018
- First submitted
- 29 Feb 2012
- Last updated
- 11 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sandler NG, Zhang X, Bosch RJ, Funderburg NT, Choi AI, Robinson JK, Fine DM, Coombs RW, Jacobson JM, Landay AL, Douek DC, Tressler R, Read SW, Wilson CC, Deeks SG, Lederman MM, Gandhi RT; AIDS Clinical Trials Group A5296 Team. Sevelamer does not decrease lipopolysaccharide or soluble CD14 levels but decreases soluble tissue factor, low-density lipoprotein (LDL) cholesterol, and oxidized LDL cholesterol levels in individuals with untreated HIV infection. J Infect Dis. 2014 Nov 15;210(10):1549-54. doi: 10.1093/infdis/jiu305. Epub 2014 May 26.
PubMed 24864123
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sevelamer Carbonate for Reducing Endotoxemia and Immune Activation: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT01543958
- Acronym / sponsor ID
- ACTG A5296
- Conditions
- HIV-1 Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other InfectionsResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Posted 25 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HIV-infected people can have an increase in inflammation in their body organs, even after taking anti-HIV medicines.
Sevelamer carbonate is used to bind phosphate in dialysis patients. It can also bind endotoxin in the gut and lowers endotoxin levels in the blood of dialysis patients. Sevelamer carbonate decreases the inflammation endotoxin causes in dialysis patients.
A5296 is a phase II, single-arm study to evaluate the effect of 8 weeks of sevelamer carbonate administration on markers of microbial translocation and T-cell activation in the blood in chronically HIV-infected subjects not receiving ART.
Detailed description
HIV-infected people can have an increase in inflammation in their body organs, even after taking anti-HIV medicines. Inflammation is a normal body reaction to any infection. However, if inflammation lasts a long time like in HIV infection, it may lead to complications, such as heart disease, cancer, liver disease, and problems with thinking. Also, HIV-infected people with high inflammation have lower CD4+ T-cell counts (cells that fight infection). Many HIV researchers are studying the harmful effects of this prolonged inflammation and possible ways to prevent these complications.
The increase in inflammation in HIV-infected people may be caused by HIV or by other factors such as parts of bacteria. These bacterial pieces, called endotoxins, do not cause harm in the intestine (gut). However, in HIV infection, there is damage to the gut that allows endotoxins to cross from the gut into the blood. These endotoxins then cause inflammation in the body. New research is focusing on strategies to reduce the levels of endotoxin as a way to decrease inflammation.
A drug called sevelamer carbonate is used to bind phosphate in dialysis patients. However, sevelamer carbonate also binds endotoxin in the gut and lowers endotoxin levels in the blood of dialysis patients. Sevelamer carbonate also decreases the inflammation endotoxin causes in dialysis patients. This study will see if sevelamer carbonate can have the same effects in HIV-infected patients.
A5296 is a phase II, single-arm study to evaluate the effect of 8 weeks of sevelamer carbonate administration on markers of microbial translocation as well as monocyte and T-cell activation in the blood in chronically HIV-infected subjects with CD4+ T-cell count ≥ 400 cells/mm3 not receiving ART. This study enrolled 40 subjects. To assess whether there is a persistent effect of study drug, subjects were observed for an additional 8 weeks off sevelamer carbonate and changes in biomarkers were monitored.
As A5296 is a phase II study of biologic activity, the primary and secondary analyses are as-treated, limited to subjects who have data for baseline and week 8 and who remain on study treatment through week 8. For any subject who initiated antiretroviral treatment (ART), analyses only included data collected prior to the time ART was started.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sevelamer carbonate | Experimental | Drug: Sevelamer carbonate, Device: Sevelamer carbonatePatients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- HIV-1 infection
- No plans to initiate ART during the course of the proposed study.
- Screening CD4+ T-cell count ≥ 400 cells/mm3 performed in a laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent.
- HIV-1 RNA >50 copies/mL within the last 180 days prior to entry.
- Screening serum phosphate > 2.6 mg/dL within 60 days prior to entry.
Key exclusion criteria (19 listed)
- Known diagnosis of acute HIV infection within 180 days prior to study entry.
- Pregnant or breastfeeding.
- Use of any antiretroviral agent within 24 weeks prior to study entry.
- Use of systemic cancer chemotherapy or radiation therapy, immunosuppressive or immunomodulatory therapy (e.g., interferons, tumor necrosis factor antagonists, interleukins, systemic corticosteroids) within 24 weeks prior to study entry.
- NOTE A: Use of inhaled steroids, nasal steroids, topical steroids, or the equivalent of 10 mg of prednisone or less per day or a less than 2-week course of oral steroids is not exclusionary.
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 |
|---|---|---|
| Sevelamer carbonateAlso: RenvelaPatients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks. | Drug | Sevelamer carbonate |
| Sevelamer carbonateAlso: Renvela | Device | Sevelamer carbonate |
Primary outcome
Change in Endotoxin
Time frame: baseline and Week 8
Change in LPS from baseline to week 8, where baseline value is the average of pre-entry and entry values.
Change in Soluble CD14 (sCD14)
Time frame: baseline and week 8
Change in soluble CD14 (sCD14) from baseline to week 8, where baseline value is the average of pre-entry and entry
48 secondary outcomes
Change in Endotoxin
Time frame: baseline and week 4
Change in Endotoxin
Time frame: week 8 and week 16
Change in sCD14
Time frame: baseline and week 4
Change in sCD14
Time frame: week 8 and week 16
Change in CD4+ T-cell Activation
Time frame: baseline and week 8
Change in CD4+ T-cell Activation
Time frame: baseline and week 4
Change in CD4+ T-cell Activation
Time frame: week 8 and week 16
Change in CD8+ T-cell Activation
Time frame: baseline and week 4
Change in CD8+ T-cell Activation
Time frame: Baseline and Week 8
Change in CD8+ T-cell Activation
Time frame: week 8 and week 16
Change in Proportion of Cycling CD8+
Time frame: baseline and week 4
Change in Proportion of Cycling CD8+
Time frame: baseline and week 8
Change in Proportion of Cycling CD8+
Time frame: from week 8 to week 16
Change in Proportion of Cycling CD4+
Time frame: baseline and week 4
Change in Proportion of Cycling CD4+
Time frame: baseline and week 8
Change in Proportion of Cycling CD4+
Time frame: week 8 and week 16
Change in Blood Phosphate Levels
Time frame: from baseline to week 4
Change in Blood Phosphate Levels
Time frame: Baseline to Week 8
Change in Blood Phosphate Levels
Time frame: from week 8 to week 16
Change in log10 HIV RNA Levels
Time frame: baseline and week 4
Change in log10 HIV RNA Levels
Time frame: baseline and week 8
Change in log10 HIV RNA Levels
Time frame: week 8 and week 16
Change in CD4+ T-cell Counts
Time frame: baseline and week 4
Change in CD4+ T-cell Counts
Time frame: baseline and week 8
Change in CD4+ T-cell Counts
Time frame: week 8 and week 16
Change in IL-6
Time frame: baseline and week 4
Change in IL-6
Time frame: baseline and week 8
Change in IL-6
Time frame: week 8 and week 16
Change in C-reactive Protein (CRP)
Time frame: baseline and week 4
Change in CRP
Time frame: Baseline and Week 8
Change in CRP
Time frame: week 8 and week 16
Change in D-dimer
Time frame: baseline and week 4
Change in D-dimer
Time frame: baseline and week 8
Change in D-dimer
Time frame: week 8 and week 16
Change in Tissue Factor
Time frame: baseline and week 4
Change in Tissue Factor
Time frame: baseline and week 8
Change in Tissue Factor
Time frame: week 8 and week 16
Change in Total Cholesterol
Time frame: baseline and week 8
Change in Total Cholesterol
Time frame: week 8 and week 16
Change in LDL Cholesterol
Time frame: baseline and week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24864123Sandler NG, Zhang X, Bosch RJ, Funderburg NT, Choi AI, Robinson JK, Fine DM, Coombs RW, Jacobson JM, Landay AL, Douek DC, Tressler R, Read SW, Wilson CC, Deeks SG, Lederman MM, Gandhi RT; AIDS Clinical Trials Group A5296 Team. Sevelamer does not decrease lipopolysaccharide or soluble CD14 levels but decreases soluble tissue factor, low-density lipoprotein (LDL) cholesterol, and oxidized LDL cholesterol levels in individuals with untreated HIV infection. J Infect Dis. 2014 Nov 15;210(10):1549-54. doi: 10.1093/infdis/jiu305. Epub 2014 May 26.
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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.
Rajesh Gandhi, MD study chair
Massachusetts General Hospital ACTG CRS
Netanya Sandler, MD study chair
National Institutes of Health (NIH)
15 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 Sevelamer carbonate in people with HIV-1 Infection, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections at 15 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 16 inclusion and 19 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Yes. Results are posted in the registry (first posted 25 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Endotoxin (time frame: baseline and Week 8). The study lists 2 primary outcomes in all. 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 NCT01543958, 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 11 Oct 2018.