AIDS Clinical Trials at a Glance:  

November 2008

(UH) indicates trials available at Case/University Hospitals.  

(M) indicates trials available at MetroHealth Medical Center. 

To receive more information or for questions regarding AIDS clinical trials 
at Case/University Hospitals of Cleveland, contact: 

Dawn Antosh, RN at 216-844-AIDS (2437) 

To receive more information or for questions regarding AIDS clinical trials 
at  MetroHealth Medical Center, contact:  

Ann Conrad, RN at 216-778-5489

 

To look at details of a specific trial, 
click on the trial number in the right column.

Salvage Treatment: For people whose antiretroviral medications are not working

Evaluates new anti-HIV medicines for people who are failing their protease-inhibitor containing regimen, are triple-class experienced and resistant to multiple anti-HIV medicines. 

5241 OPTIONS Study

 Immune Restoration

Identify a biologically active dose of Interleukin-7 CYT107 in patients on HAART with viral suppression but inadequate CD4 T cell count

Cytheris 107

Hepatitis A/B Vaccination for HIV Mono-infected and HIV/Hep C Co-infected persons

Measures immune response of study  participants of vaccinations in HIV mono-infected and HIV/Hepatitis C Co-infected people 

5232

Vaccines 

HPV Vaccine for HIV-positive women (UH)(M) 5240
Vaccine Trial for HIV-positive people (UH)(M) 5176

Other Complications: Trials looking at side effects of HIV and/or anti-HIV medications

Prospective study to assess the role of mitochondria in lipoatrophy (UH) AIDS257
 

A5241: The OPTIONS Study: A Study For People Whose HIV medicines Are Not Working to Control Their Viral Load.

Brief Description: This study will look at whether newer anti-HIV drugs are safe and effective in a group of HIV- infected persons whose current HIV medicines are not working and whether using a specific type of medicines,  nucleoside reverse transcriptase inhibitors (NRTIs), are needed to treat persons failing their current medicines.  This study will also look to see whether a medicine resistance test scoring system called cPSS (continuous phenotype susceptibility score) is able to predict which drugs will work best in people whose virus is resistant to specific HIV medications.

Major Requirements to Enter Study: 

  • HIV-1 positive  people 18 years of age and older

  • HIV viral load of 1000 or higher
  • Currently on an HIV medicine regimen that includes a protease inhibitor (PI)
  • Had exposure and have resistance to multiple types of HIV medications 
  • Never have taken an HIV medicine called an integrase inhibitor
  • Does not have active hepatitis B

 Part One:  Selecting your new medicines.  Part one of the study may last up to 60 days.   
Step A:  New HIV Medicines.  When you first enter the study, you will remain on your current HIV medicines while the study physicians review your resistance testing, your cPSS score and the type of virus that you have, as well as your previous medication history. The study physicians will recommend to you and your primary physician one or more new HIV medicine regimens that will give a cPSS test score above 2.  Some of the recommended medicines may need to be taken by injection.  If there are two or more combinations that may work for you, your primary doctor and you will pick one. If the study physicians and your primary doctor cannot choose a study drug combination that will give a cPSS score above 2, you might enter part two of the study.  

 Step B:  NRTIs or no NRTIs.   When the study physicians recommend the possible new HIV drugs combinations to your primary physician and you, they will also recommend a combination of NRTIs based on the results of the resistance testing. Again, if there is more than one possible NRTIs combination choice, your primary doctor and you will be able to pick one you might take.  However, only one-half of the people in the study will take the NRTI medicines along with their new HIV medicine regimen.  Whether you include NRTIs in your new HIV medicine regimen will be decided through randomization (chosen as if by a flip of a coin). 

 Part Two:  Monitoring your health while taking the new medicines.  Part two of the study will last 48 weeks.   During part two of the study, you will receive your medicines and return to the clinic at least 8 times for a health check up.  At these visits your HIV viral load and CD4 cell count will be tested. If the new drugs do not work to make your viral load low enough, you will have another resistance test done as part of the study; results of these tests will be given to your primary doctor. 

 Study Drugs The anti-HIV drugs that will be provided through the study are:  enfuvirtide, raltegravir, darunavir, tipranavir, etravirine and maraviroc.  Which of these drugs are recommended for you depends on the results of the testing done in the Part One of the study.  Although they may be recommended by the study doctors, NRTIs and ritonavir will not be provided through the study.

Length of Study: The study will last approximately 14 months (a little over one year).  
Compensation:  You will be compensated for two study visits.  

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Cytheris 107:  Identification of a biologically active dose of Interleukin-7 CYT107 in patients on HAART with viral suppression but inadequate CD4 T cell count

 Primary Objective:  To determine the safety and identify a biologically active dose of CYT107 (3 doses, 1 does per week for 3 weeks) in chronically HIV infected patients receiving antiretroviral therapy, with  CD4 T lymphocyte counts between 101-400 cells/mm and plasma HIV RNA <50 copies/mL for at least 6 months.   

Major Requirements to Enter Study: 

  • HIV-1 positive  people 18 years of age and older

  • On HAART for for at least 12 months and on stable treatment for at least 3 months
  • 2 consecutive measurement of CD4 cells count >101 and < 400 
  • 2 consecutive plasma HIV RNA <50 copies/mL  
  • No category C AIDS-defining illness within previous 6 month
  • No history of malignancy, HIV related encephalopathy
  • No hepatitis B or C
  • No use of tipranavir/ritonavir or enfuvirtide or any investigational antiretroviral agents
  • No previous treatment with IL-2 or IL-7
  • No need for anticoagulant medication

Treatment:  Subcutaneous injections of Interleukin-7 CYT107 at rate of 1 injection per week for 3 weeks.  Dose escalation study with 3 dose levels cohorts: Cohort A: 10 µg/kg/week   Cohort B: 20 µg/kg/week 
Cohort C: 30 µg/kg/week.  Steering committee review of safety data, pharmacokinetics and immunogenicity prior to enrollment of subsequent cohorts.

Duration of Study:  28 days on study with 3 month follow up.  Up to 12 months post-study follow-up.

Compensation:  Compensation is paid to participants.

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A5232: Optimizing Vaccine Responsiveness in HIV-1 and HCV Infections by Identifying Determinants of Responsiveness: A Pilot Study

Brief Description:  A5232 is a 24-week research study, which is enrolling people who have hepatitis C, people who are HIV-positive, and people who are co-infected with HIV and hepatitis C.  Participants will be given two types of vaccines: diphtheria/tetanus toxoid and hepatitis A and B.  The study will look at the immunological effects of the vaccinations.    

Purpose of this Clinical Trial:  A5232 is a pilot study to look at the extent of immune defects in people who have hepatitis C, HIV, and both.  This will be done by immunizing people with antibodies to both tetanus toxoid and hepatitis A and B, and evaluating their immune systems’ responses. 

Major Requirements to Enter Study:

  • Men and Women ages 18-65 who have not had prior exposure to the hepatitis A or B vaccine;
  • Hepatitis A antibody negative; hepatitis B surface antigen and antibody negative.
  • The study will enroll three groups (called “Arms”) of people:
    • Arm A:  (currently not enrolling at Case/UHC) People who have chronic hepatitis C infection (and do not have HIV infection):
      • Defined as PCR positive without previous Hepatitis C therapy and without the presence of Child’s B or C cirrhosis;
    • Arm B: People who have HIV infection (and do not have hepatitis C infection)
      • Who have not taken more than 7 days of antiretroviral therapy (HAART);
      • CD4 count of 300 or more;
      • No prior or current opportunistic infections;
      • With no indication of need for antiretroviral therapy
    • Arm C:  People who have both hepatitis C and HIV infection, and meet the requirements of both Arm A and B

Treatment:   All participants will receive a vaccination for diphtheria/tetanus toxoid, and a combined hepatitis A and B vaccine. 

Length of Trial:  24 weeks

Compensation:  Trial participants receive compensation.

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A5240: A study for HIV-positive women to determine the safety and effectiveness of the HPV vaccine, Gardasil.     

Brief Description:  Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States and worldwide.  There are over 90 types of HPV that infect humans.  Some of these types infect the genital and anal areas where the infection causes genital and anal warts.  It also causes cancer of the cervix (the opening of the uterus) in females.  HPV infection may be more severe and harder to treat in people infected with HIV.  The FDA has approved an HPV vaccine (called Gardasil), and it is directed against 4 types of HPV which are the most common causes of genital warts and cervical cancer.  This study is the first of its kind to test the HPV vaccine in females infected with HIV.

Purpose of this Study:  This study will see if the HPV vaccine, when given in 3 separate doses, is safe and tolerable in females infected with HIV.  This will be done by asking how you feel and if you had any reactions after each dose of the vaccine.  The study will also check if the HPV vaccine can help the body make substances in response to the vaccination to help fight off disease caused by HPV.

Requirements to Enter Study:  
·         HIV-positive females, ages 18-45 years old.
·         Any T-cell count and any viral load is acceptable.   
·         If you are taking antiretroviral drugs, you must be on the same combination of medicines for at least 12 weeks before the study entry visit.  You do not need to be on antiretroviral drugs to be eligible for this study.
·         No cervical cancer, very abnormal Pap smear, or genital warts within 180 days.
·         No prior vaccinations for HPV.
·         Cannot take any of the disallowed medications.  Your study nurse will discuss these with you.

Treatment: 
Study treatment is defined as quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine, Gardasil, and will be provided to you by the study.  Quadrivalent means that the vaccine is directed at four types of HPV.  If you are currently taking antiretroviral drugs, you should continue taking them unless your doctor tells you otherwise.  Your antiretroviral drugs will not be provided to you by the study.  You must get them through your primary care provider.

Duration of Study: This study will last about one and a half years.

Compensation:  You will be provided compensation for participation in this study.            

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A5176: A Clinical Trial of a Vaccine for HIV+ People

 Purpose of the Clinical Trial:  This Phase I/II* study is being done to find out whether DermaVir vaccine (LC002) is safe and tolerable in humans and what the best dose is for treating HIV infection in people who are currently on antiretroviral medications (HAART).  The safety of DermaVir is currently being studied in persons with HIV in another study in Europe .

 * A Phase I clinical trial is one in which a study medicine is given to a small group of people to evaluate its safety.  A Phase II clinical trial is one in which the study medication is given to larger groups of people to see if it works and to further evaluate its safety.

 How It Works:  Study treatment is DermaVir or DermaVir placebo. Depending on when you enter in the study you will be registered to one of the three groups noted below. In the group you are registered in you will be assigned (by chance, like the flip of a coin) to receive either DermaVir vaccinations or placebo vaccinations (a placebo is the same vaccine without an active component). You have a 75% chance of actually receiving the DermaVir vaccine and a 25% chance of receiving the placebo vaccine:

- If you enter into group 1 you will receive low dose vaccinations at weeks 1, 7, and 13 (applied over 2 skin sites).

- If you enter into group 2 you will receive high dose vaccinations at weeks 1, 7, and 13 (applied over 4 skin sites).

- If you enter into group 3 you will receive high dose vaccinations at entry and at weeks, 0, 1, 6, 7, 12, and 13 (applied over 4 skin sites).

 This new vaccine will not be injected into your body like other vaccines. It will be applied to your skin (after a special skin preparation process is completed) in order to target immune cells (known as Langerhans cells) located just under the surface of your skin. These Langerhans cells must pick up the vaccine in order to train your body to fight HIV-1.

 Key Requirements to Enter Study:

-          HIV-positive people, ages 18-50 years old;           

-          HIV Viral load less than 50 and CD4+ T-cell count greater than 350;

-          On a stable HAART without changes or interruptions (for more than 4 consecutive days) for at least 12 weeks prior to study entry;

-          No history of AIDS-defining illnesses, diabetes, major active skin diseases and chronic autoimmune or bleeding disorders

 Duration of Study:  61 weeks

 Compensation Provided to Participants.

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AIDS 257:  A study to assess the role of mitochondria in lipoatrophy

Purpose of Study:  This study will evaluate the role of mitochondria in lipoatrophy w hich is the loss of fat from specific areas of the body, including the face, legs and buttocks. 

Major Requirements to Enter the Study:  18 years old or older; either naive and about to start HAART (anti-HIV medicines) or already taking HAART and on stable regimen of ZDV or d4T with lipoatrophy.

Brief Description:    Group 1: ARV naive patients ready to start 1st antiretroviral therapy. ARV must include d4T, ZDV, or ddI and a non-nucleoside or Atazanavir (boosted or not).  

Group 2: ARV-experienced patients, with lipoatrophy, randomized to 2 Arms: 
Arm 1) patients will continue current regimen with uridine (Nucleomaxx) added; 
Arm 2) patients will have d4T or ZDV changed to Tenofovir. 

Study will include 3 fat biopsies by plastic surgeon under local anesthetic.  Only Nucleomaxx for Arm 1 will be provided.  Compensation for all visits and each biopsy. 

Length of Trial:  48 weeks

Compensation:  Compensation provided. 

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To receive more information or for questions regarding AIDS clinical trials at Case/University Hospitals of Cleveland, contact: 

Dawn Antosh, RN at 216-368-AIDS. 

To receive more information or for questions regarding AIDS clinical trials at  MetroHealth Medical Center, contact:  

Ann Conrad, RN at 216.778.5489