Trial record 17 of 35 for:    " October 13, 2010":" November 12, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Hydroxychloroquine for Discordant CD4 Responders on Highly Active Antiretroviral Therapy (HAART) (SSAT039)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by St Stephens Aids Trust
Sponsor:
Information provided by (Responsible Party):
St Stephens Aids Trust
ClinicalTrials.gov Identifier:
NCT01232660
First received: October 29, 2010
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to examine the effects of adding a drug called hydroxychloroquine, usually used to treat rheumatoid arthritis, to patients' usual antiretroviral combination. HIV causes activation of some parts of the immune system and this immune activation may persist despite effective antiretroviral therapy. Ongoing activation may be responsible for poor CD4 rise on antiretroviral therapy and for some HIV-related complications. Drugs like hydroxychloroquine work by inhibiting immune activation.

The study will primarily investigate the effect of adding this medication on immunological parameters (particularly CD4 count), on other safety parameters (such as cholesterol), patients' side effects and viral load.

If you decide to take part, the duration of your involvement in the study will be 24 weeks plus two screening visits up to 84 days prior to the start of the study and a follow up visit.


Condition Intervention Phase
HIV Infection
Drug: Hydroxychloroquine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Immunological Impact of Adding Hydroxychloroquine in Patients With Discordant CD4+ Cell Responses to Suppressive HAART: A Phase I Pilot Study.

Resource links provided by NLM:


Further study details as provided by St Stephens Aids Trust:

Primary Outcome Measures:
  • Change in CD4 from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To measure the change in CD4 from baseline after 12 weeks of hydroxychloroquine therapy


Estimated Enrollment: 12
Study Start Date: October 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Delayed
Delayed addition of hydroxychloroquine in patients with discordant CD4+ cell responses to suppressive HAART
Drug: Hydroxychloroquine
Hydroxychloroquine 400mg once daily orally
Experimental: Immediate
Immediate addition of hydroxychloroquine in patients with discordant CD4+ cell responses to suppressive HAART
Drug: Hydroxychloroquine
Hydroxychloroquine 400mg once daily orally

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented HIV infection
  • Age 18 to 65 years.
  • On stable antiretroviral therapy for at least 96 weeks
  • CD4 count less than 350 on screening blood test and on one other test performed within 4 months prior to screening and less than 150 cell rise in CD4 count in last 3 years
  • Expression of CD38 on CD8+ T cells >10%
  • Plasma HIV RNA viral load less than 50 copies/ml on screening blood test and for at least 72 weeks prior to screening (blips defined as a single viral load >50 and <500 copies/ml preceded and followed by an undetectable result will be permitted)
  • Willing and able to provide written informed consent
  • Females of child-bearing potential will need to use effective contraception
  • Satisfactory ophthalmological assessment including:

    • visual acuity
    • careful ophthalmoscopy
    • fundoscopy
    • central visual field testing with a red target
    • colour vision.

Exclusion Criteria:

  • History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy, cardiac arrhythmias or glucose 6-phosphate dehydrogenase (G6PD) deficiency.
  • Insulin-dependent or non-insulin-dependent diabetes mellitus.
  • Chronic liver disease of any cause or alcoholism (investigator defined)
  • Pneumonia, meningitis, septicaemia or any other serious infection in the 2 months prior to screening.
  • Any acute infection with fever and systemic symptoms in the last 24 hours.
  • Any vaccinations in the 2 months prior to screening.
  • Active malignancy (patients are eligible if treatment for the malignancy was completed more than 2 years prior to screening and there has been no subsequent clinical evidence of active disease or localised completely excised cutaneous cancers and low volume Kaposi's sarcoma) or any active immune-mediated or inflammatory disease.
  • Any known suicide attempts (at any time in the past) or current or past history of depression requiring treatment within the 2 years prior to screening.
  • A woman who is currently pregnant or breastfeeding.
  • Use of systemic corticosteroids or other immunomodulatory drugs within the 12 months prior to screening.
  • Current use of medication with known serious hepatotoxic effects or known interaction with hydroxychloroquine (section 5.2)
  • Evidence of cardiac conduction defects or cardiac arrhythmia on screening ECG.
  • Hepatitis B surface antigen (HBsAg) positive or Hepatitis C PCR positive (patients who are Hepatitis C antibody positive are allowed to enter if PCR is negative).
  • Any of the following laboratory abnormalities on screening blood test:

    • Haemoglobin less than 10.5g/dl
    • Absolute neutrophil count less than 1.0x109/L
    • Platelet count less than 100 X 109/L
    • ALT or AST, or alkaline phosphatase above 2.5 x upper limit of normal (ULN) Template V 2.0, 06 April 2008 SSAT039 Page 23 of 73 Version 6.0, 17 October 2011
    • Serum creatinine greater than 1.5xULN
    • Estimated creatinine clearance (MDRD equation*) below 60ml/min
  • Inability to attend or comply with treatment or follow-up scheduling.
  • Current participation in any other clinical intervention trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232660

Contacts
Contact: Chris Higgs 0208 846 6135 chris.higgs@chelwest.nhs.uk
Contact: Carl Fletcher 0208 846 6323 carl.fletcher@chelwest.nhs.uk

Locations
United Kingdom
St Stephen's Centre Recruiting
London, United Kingdom, SW10 9NH
Sponsors and Collaborators
St Stephens Aids Trust
Investigators
Principal Investigator: Laura Waters, Dr St Stephen's AIDS Trust
  More Information

No publications provided

Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT01232660     History of Changes
Other Study ID Numbers: SSAT 039
Study First Received: October 29, 2010
Last Updated: February 10, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 19, 2014