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Sevelamer Carbonate for Reducing Endotoxemia and Immune Activation: A Proof of Concept Study

Phase 2
18 Years
Not Enrolling
HIV-1 Infection

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Trial Information

Sevelamer Carbonate for Reducing Endotoxemia and Immune Activation: A Proof of Concept Study

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

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.

- 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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in soluble CD14 (sCD14) from week 0 to week 8

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Rajesh Gandhi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital ACTG CRS


United States: Federal Government

Study ID:

ACTG A5296



Start Date:

November 2011

Completion Date:

November 2012

Related Keywords:

  • HIV-1 Infection
  • Endotoxemia
  • HIV Infections



Alabama Therapeutics CRS (5801)Birmingham, Alabama  35294-2050
UCLA CARE Center CRS (601)Los Angeles, California  90095
Northwestern University CRS (2701)Chicago, Illinois  60611
Massachusetts General Hospital ACTG CRS (101)Boston, Massachusetts  02114
Washington University CRS (2101)St. Louis, Missouri  63110
AIDS Care CRS (1108)Rochester, New York  14607
Case CRS (2501)Cleveland, Ohio  44106
Harbor-UCLA Med. Ctr. CRS (603)Torrance, California  90502
University of Colorado Hospital CRS (6101)Aurora, Colorado  80045
Univ. of Rochester ACTG CRS (1101)Rochester, New York  14642
Univ. of Cincinnati CRS (2401)Cincinnati, Ohio  45267
Metro Health CRS (2503)Cleveland, Ohio  44109
Hosp. of the Univ. of Pennsylvania CRS (6201)Philadelphia, Pennsylvania  19104
Univ. of Miami AIDS CRS (901)Miami, Florida  33136
Ucsf Aids Crs (801)San Francisco, California  94110