Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery

Completed · Phase 2

Conditions studied: HIV-1 Infection

In brief

This phase II study was done in HIV-infected participants on antiretroviral therapy to evaluate the effects of isotretinoin (a drug that is approved for use in the treatment of severe acne) on the immune system. The immune system helps the body fight infections. When the immune system is not working well, one may be at greater risk for diseases that are common in aging, like heart disease, weaker bones, and kidney disease.

Key facts

Study ID

NCT01969058

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

76

Starts

2014-07-02

Expected to finish

2016-11-01

Last updated by the study team

2024-10-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
• NOTE: The term "licensed" refers to a US FDA-approved kit, which is required for all IND studies.
• CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
• Receiving ART therapy for at least 12 months prior to study entry.
• No plans to change the ART regimen in the 6 months after study entry.
• HIV-1 RNA below the lower limit of detection using an FDA-approved assay obtained within 30 days prior to study entry by any laboratory that has a CLIA certification or its equivalent (eg, <50 copies/mL on Roche Amplicor HIV-1 Monitor assay, <75 copies/mL on the Versant HIV-1 RNA assay by branched DNA, <40 copies/mL on the Abbott m2000sp/m2000rt real-time PCR test, < 20 copies/mL on the COBAS AmpliPrep/TAQMAN HIV-1 assay).
• All measurements of HIV-1 RNA within the 12 months prior to study entry must be below the limit of detection with the following exception:
• NOTE A: 1 viral blip (<200 copies/mL) is permitted if it is preceded and followed by viral loads below the limits of detection.
• NOTE B: The virologic assay must have a lower limit of detection of ≤ 75 copies/mL.
• CD4+ cell count <350 cells/mm3 obtained at screening within 30 days prior to entry at any laboratory that has a CLIA (Clinical Laboratory Improvement Amendments) certification or its equivalent.
• The following laboratory values obtained within 30 days prior to entry by any laboratory that has a CLIA certification or its equivalent:
• Hemoglobin A1c (HgbA1c) levels ≤ 6.5%
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 50,000/mm3
• Creatinine ≤1.5 mg/dl
• CrCl ≥ 60 mL/min, calculated by the Cockcroft-Gault method
• Aspartate aminotransferase (AST) (SGOT) ≤1.5x upper limit of normal (ULN)
• Alanine aminotransferase (ALT) (SGPT) ≤1.5x ULN
• Serum lipase ≤1.5x ULN
• Fasting triglyceride level ≤200 mg/dL
• Fasting glucose <126mg/dL
• Karnofsky performance score >/=70 within 30 days prior to entry.
• Men and post-menopausal females aged ≥ 18 years and ≤ 80 years at entry.
• Note: Post-menopausal is defined as having either:
• Appropriate medical documentation (see note) of prior complete bilateral oophorectomy (i.e., surgical removal of the ovaries, resulting in "surgical menopause" and occurring at the age at which the procedure was performed), OR

You may not qualify if…

• Pre-existing diagnosis of diabetes.
• Currently receiving treatment with fibrate, nicotinic acid, tetracycline, fish oil >1g/d, or methotrexate.
• Known active healing fracture or any severe bone disorders. NOTE: does not include healed fractures or history of old fractures.
• Receipt of any of the following medications within 30 days prior to entry: systemic steroids (including intra-articular steroids; inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (including intra-articular steroid injection; local injection of interferon alpha for treatment of human papilloma virus is permitted), or systemic chemotherapy.
• Known allergy/sensitivity or any hypersensitivity to vitamin A, retinoids, or any of their derivatives.
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Acute or serious illness requiring systemic treatment and/or hospitalization within 60 days prior to entry.
• Weight < 40 kg or > 150 kg.
• History of major depression or suicide attempt requiring hospitalization, or psychotic episode requiring medication or hospitalization.
• History of inflammatory bowel disease such as Crohn's disease, or Ulcerative colitis.

Where it is running

• 31788 Alabama CRS — Birmingham, Alabama, United States
• 601 University of California, Los Angeles CARE Center CRS — Los Angeles, California, United States
• 801 University of California, San Francisco HIV/AIDS CRS — San Francisco, California, United States
• 101 Massachusetts General Hospital (MGH) CRS — Boston, Massachusetts, United States
• 107 Brigham and Women's Hosp. ACTG CRS — Boston, Massachusetts, United States
• 2101 Washington University Therapeutics (WT) CRS — St Louis, Missouri, United States
• 31786 New Jersey Medical School Clinical Research Center CRS — Newark, New Jersey, United States
• 31787 University of Rochester Adult HIV Therapeutic Strategies Network CRS — Rochester, New York, United States
• 3201 Chapel Hill CRS — Chapel Hill, North Carolina, United States
• 3203 Greensboro CRS — Greensboro, North Carolina, United States
• 2401 Cincinnati CRS — Cincinnati, Ohio, United States
• 2951 The Miriam Hospital (TMH) ACTG CRS — Providence, Rhode Island, United States
• 3652 Vanderbilt Therapeutics (VT) CRS — Nashville, Tennessee, United States
• 31473 Houston AIDS Research Team (HART) CRS — Houston, Texas, United States
• 5401 Puerto Rico AIDS Clinical Trials Unit CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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