View Clinical Trial (Medical Research Study)

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of pGA2/JS7 DNA and MVA/HIV62B in HIV-infected Adults With Suppressed Viremia Who Started ART Within 18 Months of a Negative HIV Antibody Test

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Conditions:		HIV-1 Infection
Purpose:		GV-TH-01 is an open label Phase 1 study of 10 HIV-1 infected adults with suppressed viremia who started anti-retroviral therapy (ART) within 18 months of a negative HIV antibody test. This study has 3 phases. The first phase is the vaccination phase, where patients are vaccinated with pGA2/JS7 (JS7)DNA and MVA62B vaccines on a prime/boost regimen at weeks 1 and 9 (JS7 DNA vaccine) and weeks 17 and 25 (MVA62B). Both vaccines express Gag, Pol, and Env. The second phase of the study is a treatment interruption phase, whereby ART is interrupted for a 12 week period approximately 8 weeks following the last vaccination. The third phase occurs after the 12 week treatment interruption phase and is called the treatment reinstitution phase, because subjects reinstitute ART and are followed for an additional 24 weeks. The primary objective is to evaluate the safety of the vaccines during the three phases of the study. A secondary objective is to evaluate the immunogenicity of the vaccines during the vaccination phase of the study.
Study Summary:
Criteria:		Inclusion Criteria: - Age 18 through 50 years - Time between start of ART and last documented negative HIV antibody test within 18 months; or time from negative detuned HIV-1 antibody assay to start of ART within 13 months; or time between evolution of Western blot from indeterminate to positive (as defined by CDC/ASTPHLD) in the presence of a positive antibody test and initiation of ART is within 18 months - No changes to ART treatment within 4 weeks of study entry - Documentation of level of plasma HIV-1 RNA and CD4+ counts prior to beginning ART; pretreatment HIV-RNA must be at least 8 wks following diagnosis of acute HIV-1 infection - On stable suppressive ART, defined as HIV-1 RNA < 50 copies/mL (PCR) or < 75 copies/mL (bDNA) for a minimum of 6 months prior to starting vaccination so that at least two measures must have occurred within the 6 months preceding vaccination (One may be from the chart and one at screening) - No history of virologic failure, failure defined as HIV-1 RNA > 50 copies/mL (PCR) or > 75 copies/mL (bDNA), after achieving suppression below those levels or failure to reach HIV-1 RNA < 50 copies/mL (PCR) or < 75 copies/mL (bDNA) on initial antiretroviral regimen (Substitutions due to intolerance are allowed) - CD4+ > 500 cells/µL - Nadir CD4+ > 350 cells/µL unless measured in the setting of acute infection - Laboratory values: - Hemoglobin ≥ 10g/dL (male) or 9g/dL (women) - ANC > 1000 cells/µL - ALT, AST ≤ 2.5 ULN - Total bilirubin < 1.5 x ULN (≤ 5 x ULN on atazanavir) - Fasting glucose ≤ 125 mg/dL - Serum creatine < 1.5 x ULN - Creatinine clearance ≥ 60 mL/min (Cockcroft-Gault) - Serum creatine phosphokinase (CPK) ≤ 1.5 x ULN - UA negative for hemoglobin and glucose and no greater than 1+ protein - Any abnormalities must be assessed by the investigator as not clinically significant - ECG without evidence of current or past MI, or ischemic heart disease - Willing to provide signed informed consent - Female subjects must have a negative serum or urine β-HCG pregnancy test at screening - Female subjects of reproductive potential (not having reached menopause or not having undergone hysterectomy, bilateral oophorectomy, or tubal ligation) who engage in sexual activity that could lead to pregnancy must agree to avoid pregnancy and agree to consistently use contraception for at least 21 days prior to first vaccination until the last protocol visit. - Contraception is defined as using at least one of the following methods: - Condoms (male or female) - Diaphragm or cervical cap - Intrauterine device (IUD) - Hormonal contraceptive with one of the following: condoms, diaphragm or cervical cap - Male subjects participating in the study must agree to not attempt to impregnate a female, or participate in sperm donation programs - Males engaging in sexual activity that could lead to pregnancy must use a condom from the date of receipt of the first study vaccine until the last protocol visit - Male and female subjects participating in the study must agree to use condoms for protection against HIV-1 transmission throughout the study - Participants must be willing to comply with all study requirements and expected to be available for the duration of the study - Participants must be willing to temporarily discontinue antiretroviral therapy for up to 12 weeks post-vaccinations Exclusion Criteria: - Known infection with HIV-1 subtype other than Clade B - Receipt of chemotherapy for active malignancy in the past 12 months - Prior vaccinations with any HIV-1 vaccine - Prior vaccination against smallpox within the last 15 years - History of or known cardiac disease including: - myocardial infarction - angina pectoris - congestive heart failure - cardiomyopathy - pericarditis - stroke or transient ischemic attack - symptoms suggestive of cardiac disease in the opinion of the investigator - History of myositis - Diagnosis of HIV-associated nephropathy - Evidence of active hepatitis B or C infection, including positive HBsAG or positive hepatitis C antibody - Framingham Global Risk Assessment Score consistent with high short-term (10 year) cardiac risk - Receipt of immunomodulatory agents, systemic corticosteroids (including nonprescription street steroids), gamma globulin, or investigational agents (other than H1N1 influenza vaccine) within 6 months of screening - Any immunization within 1 month of screening - Creatine supplements within 14 days of baseline and unwillingness to discontinue use throughout the trial - Changes in ART regimen prior to entry due to virologic failure (not including toxicity) - Pregnancy or breastfeeding - Any clinically significant diseases (other than HIV-1 infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise participant safety - Active alcohol or substance abuse, defined as use that is likely to interfere with the ability of the subject to adhere to medications, return for study visits or lead to adverse events - Allergy to chicken egg derived products - Contraindication to intramuscular injection such as anticoagulant therapy or thrombocytopenia - Unwilling to forego vigorous exercise 3 days prior to each vaccination
NCT ID:		NCT01378156
Primary Contact:		Study Chair Harriet L Robinson, PhD GeoVax, Inc.
Backup Contact:		N/A
Location Contact:		Los Angeles, California 90015 United States Stephen Brown, MD Phone: 310-358-2428 Email: s.brown@aidsresearch.org Site Status: Recruiting

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