Phase II trial to determine safety and efficacy of an anti-HIV-1 gene transfer product.

Condition	Treatment or Intervention	Phase
HIV Infections	Gene Transfer: OZ1 (anti-HIV-1 gene)	Phase II

Further Study Details: 

Primary Outcomes: viral load
Expected Total Enrollment:  74

Ages Eligible for Study:  18 Years   -   45 Years,  Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:

• HIV-1 infection for at least 6 months documented by positive HIV serology and confirmed by Western Blot.
• Aged between 18 – 45 years.
• Receiving either the first or second regimen of ART (3 or more antiretroviral drugs in combination) for more than 6 months consecutively prior to study entry and maintaining suppression of viral load (less than 400 copies/ml) during the same period. Early mono or dual therapy either with or without the subsequent addition of one or more antiretroviral agents will be considered as one regimen. The addition of an antiretorviral agent to an exisiting ART combination for intensification of a regimen that is maintaining viral suppression will not be classified as a new regimen. Substitution of drugs in the same drug class due to toxicity is not considered a change in ART regimen.
• Viral load less than 400 copies/ml, on two consecutive occasions, at least seven days apart. The second measurement must be within 14 days prior to G-CSF.
• CD4+ cell count greater than 300 cells/mm3 measured on two consecutive occasions, at least 7 days apart. The second measurement must be within 14 days prior to G-CSF.
• Women and men participating in this study (or their partners) must agree to use a medically accepted barrier form of contraception (i.e. male or female condoms or diaphragm). Women must have a negative serum pregnancy at screening and again within 7 days prior to G-CSF.

EXCLUSION CRITERIA:

• Any previous or current AIDS-defining illness by the CDC case definition, including AIDS-related dementia, with the exception of Kaposi’s sarcoma.
• Abnormal laboratory results at screening:

** Hemoglobin < 8.5 g/dl for males and < 8 g/dl for females

** Platelet count < 100,000 cells/mm3

** SGOT (AST) > 5 x upper limit of normal.

** Serum creatinine > 1.5 x upper limit of normal.

** Total bilirubin > 1.5 x upper limit of normal unless due to elevated indirect bilirubin obtained in a patient receiving indinavir and in the absence of any significant liver disease.

• Patients with antecubital veins unsuitable for apheresis and unable to consent to the insertion of a catheter into an alternate vein (i.e. femoral, subclavian, jugular).
• Patients whose ART combinations exhibit antagonism when used together (e.g. zidovudine [AZT] and stavudine [d4T])or whose current or previous ART includes hydroxyurea - Participation in any study involving an experimental drug or an experimental medical device in the 30 days prior to study entry, with the exception of FDA approved Phase III IND antiretroviral therapeutics.
• Previous participation at any time in any study involving a gene transfer product.
• Inability to provide informed consent.
• Current pregnancy or lactation.
• Any concurrent disease or reason that, in the opinion of the Investigator, would constitute a hazard for participating in the study. In particular, this includes any serious or chronic illnesses potentially affecting the risks of administration of G-CSF and of apheresis, such as bleeding or thromboembolic disorders, CD34+ cell engraftment, hematopoiesis and/or interpretation of results.
• Continued alcohol consumption, drug abuse or other condition which, in the judgment of the Investigator, raises significant doubt about the patient's ability to comply with protocol requirements.
• Known hypersensitivity to E. coli -derived recombinant proteins e.g. G-CSF.
• Current Hepatitis B virus infection
• Previous participation in any study that may have a long term impact on viral dynamics e.g. vaccine studies.

California
      University of California Los Angeles (UCLA) CARE Center, Los Angeles,  California,  90095-1793,  United States; Recruiting
      Stanford University, Department of Medicine, Division of Infectious Disease, Stanford,  California,  94305-5107,  United States; Recruiting
      AIDS Healthcare Foundation Research Centre, Los Angeles,  California,  90015,  United States; Recruiting
      Akil MB, Los Angeles,  California,  90046,  United States; Recruiting
      Pacific Horizon Medical Group, San Francisco,  California,  94115,  United States; Recruiting
Australia, New South Wales
      St Vincent’s Hospital; HIV, Immunology & Infectious Diseases Clinical Services Unit, Darlinghurst,  New South Wales,  2010,  Australia; Recruiting
      Albion Street Centre, Surry Hills,  New South Wales,  2010,  Australia; Recruiting
      AIDS Research Initiative, Darlinghurst,  New South Wales,  2010,  Australia; Recruiting
      Holdsworth House General Practice, Darlinghurst,  New South Wales,  2010,  Australia; Recruiting
      Taylor Square Private Clinic, Darlinghurst,  New South Wales,  2010,  Australia; Recruiting
      407 Doctors, Surry Hills,  New South Wales,  2010,  Australia; Recruiting

Study ID Numbers:  OTH/OZ1-INT-1; NIH/OBA Protocol 0107-486
Record last reviewed:  November 2004
Last Updated:  November 4, 2004
Record first received:  December 28, 2003
ClinicalTrials.gov Identifier:  NCT00074997
Health Authority: United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08