Open & Enrolling Clinical Trials

5294

HEPATITIS C AND HIV CO-INFECTION STUDY
A 72 week study adding a newly FDA approved drug for Hep C, Boceprevir to standard Hepatitis C treatment. All Hepatitis C drugs will be provided by the study.
Key requirements:

• Must have both Hepatitis C and HIV
• 18 years of age or older
• HIV viral load less than 50,000
• CD4 count of more than 200
• Prior treatment for Hepatitis C permissible.

Contact:
Debbie Perez
401-793-4632 of
dperez@lifespan.org

UNITE

hEPATITS c AND hiv cO-INFECTION sTUDY
This is a study that could last up to 2 years to evaluate a newly FDA approved Hepatitis C medication given along with current Hepatitis C treatment  for people infected with both HCV and HIV
Key requirements:

• Must be co-infected with HIV and HCV
• Must be between the ages of 18 and 65
• Must be on a stable HIV regimen that includes, Raltegravir, Sustiva, or Atazanavir
• CD4 of 200 or greater
• HIV viral load of 50 or lower
• Cannot be pregnant or become pregnant during length of study

Contact:
Pam Poethke
401-793-4971
ppoethke@lifespan.org
or
Patricia Delgado,
401-793-4769
pdelgado@lifespan.org

HEPCAT

A Study for people infected with Hepatitis C and never been treated
This 24 to 48 week study compares a new drug, daclatasvir, and the standard anti-Hepatitis C treatment with a recently FDA approved drug, Teleapravir, and standard Hepatitis C treatment
Key requirements:

• Must have hepatitis C and never been treated
• Must be 18 years of age or older
• Must be HIV negative and not infected with hepatitis B
• Must not be pregnant/breastfeeding or planning to become pregnant
• Cannot have serious liver, psychiatric, blood, thyroid, hearing or eye disease

Contact:
Pam Poethke
401-793-4971
ppoethke@lifespan.org
or
Patricia Delgado,
401-793-4769
pdelgado@lifespan.org

5298

An HPV Vaccine Study for HIV+ men who have sex with men
This is a new study to show that the HPV vaccination prevents persistent anal infection with HPV types contained in the vaccine. You will get the injections of the HPV vaccine within 24 weeks and followed for 3 to 4 years afterward.
Key requirements:

• HIV+ men age 27 or older
• Receptive anal sex within 1 year prior to entry
• High resolution anoscopy performed withing 45 days prior to entry.
• Cannot: 1) have history of anal, penile or oropharyngeal cancer, 2) have used topical or surgical treatment for anal neoplasia or warts/condyloma within 6 months prior to entry,
•  3) have received a prior HPV vaccine

Contact:
Helen Patterson
401-793-464771 or hpatterson@lifespan.org

5303

A STUDY FOR PEOPLE WHO HAVE NEVER USED HIV MEDICATIONS AND NEED TO BEGIN
This is a 48 week study is to compare the effects on bones of two different HIV drug regimens. All of the medications in this study are approved by the FDA and are currently used for the treatment of HIV.
Key requirements:

• HIV positive and never used HIV medication
• Viral load of 1000 or greater and need to begin therapy
• Cannot be pregnant or breastfeeding
• No active Hepatitis B
• No history of bone fracture related to osteoporosis
• Never used bone therapies

Contact:
Pam Poethke
401-793-4971
ppoethke@lifespan.org

GSK CSF

A STUDY FOR PEOPLE WHO ARE HIV POSTIVE AND HAVE NEVER TAKEN HIV MEDICATIONS
A two year study to see how much of an investigational drug, dolutegravir, gets into the cerebral spinal fluid (the fluid around the spinal cord and brain).
Key requirements:

• 18 years of age or older
• CD4 of 200 or greater
• Have not taken HIV medications in the past
• Not pregnant or planning to become pregnant during the course of the study
• Willing to undergo 3 lumbar punctures
• Cannot have liver imparement

Contact:
Helen Patterson
401-793-464771 or hpatterson@lifespan.org
or
Patricia Delgado,
401-793-4769
pdelgado@lifespan.org

Alcohol & HIV

A 3 year study to look at the effects of alcohol on the brain of people with HIV. Three appointments per year, each lasting from 50 minutes to 2 hours. You will participate in memory, reaction time and cognitive testing, as well as a MRI of the brain.

Key requirements:

• HIV positive or negative
• Users and non-users of alcohol
• Between ages 21 and 70

Contact:
Skye Ross
401-793-4364