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

NCT01232660 | Unknown Phase 1

• 1 other identifier: SSAT 039
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

• Change in CD4 from baseline

  To measure the change in CD4 from baseline after 12 weeks of hydroxychloroquine therapy

  12 weeks

Study Arms (2)

Delayed

ACTIVE COMPARATOR

Delayed addition of hydroxychloroquine in patients with discordant CD4+ cell responses to suppressive HAART

Drug: Hydroxychloroquine

Immediate

EXPERIMENTAL

Immediate addition of hydroxychloroquine in patients with discordant CD4+ cell responses to suppressive HAART

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine 400mg once daily orally

Delayed; Immediate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St Stephens Aids Trust: lead

Study Sites (1)

St Stephen's Centre

London, SW10 9NH, United Kingdom

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Laura Waters, Dr

  St Stephen's AIDS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Higgs

CONTACT

0208 846 6135; chris.higgs@chelwest.nhs.uk

Carl Fletcher

CONTACT

0208 846 6323; carl.fletcher@chelwest.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 2, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 11, 2014

Record last verified: 2014-02

Locations

GB (1)