CURRENT STUDIES
All
A5294 (Boceprevir)
Brief Description:
You are being asked to take part in this research study because you are infected with both HIV (the virus that causes AIDS) and HCV (a virus that causes hepatitis; an inflammation of the liver, specifically genotype 1 which is one of the main types of hepatitis C). This is often referred to as coinfection. Treatment for the HCV virus usually consists of a combination of two drugs known as pegylated-interferon alfa 2b (PEG-IFN) and ribavirin (RBV). Treatment response in HCV infected persons is measured by SVR (sustained virologic response, which is the proportion of patients who have no measurable virus in blood six months after completing treatment). SVR is lower among persons who have HIV coinfection compared to those who have HCV infection alone and is higher among those who have never been treated before compared to those who have previously failed treatment. Among treatment naïve HIV and HCV genotype 1 coinfected individuals treated with PEG-IFN and RBV, SVR is generally less than 25% (vs. 40-45% in those with HCV alone); among previously treated persons, SVR is achieved in 10% or less. In 2011, two new drugs were approved in the U.S. (Boceprevir [BOC] and Telaprevir) to treat HCV in those infected with HCV alone. These agents, when used in combination with PEG-IFN/RBV have yielded SVR rates of 65-72% in subjects with HCV infection alone. However, studies of these agents in those coinfected with HIV are lacking.
Purpose of this Study:
This study is being done to see if adding a third drug to this combination is safe and whether it will help people with both HIV and HCV better fight their HCV. The third drug that this study is investigating has already been approved by the Food and Drug Administration (FDA) recently for the treatment of people who are infected with HCV alone.
Requirements to Enter Study (Groups A and B):
- Documented HIV infection and ≥18 years of age
- Presence of chronic HCV infection with a positive HCV RNA >180 days ago and current
HCV viremia or a positive liver biopsy demonstrating chronic hepatitis
- HCV RNA ≥10,000 copies and screening genotype 1 performed within 42 days prior to
study entry
- Viral load < 50,000 copies or T-cell count >200 cells within 42 days prior to study entry
- Liver biopsy within 104 weeks prior to study entry
- Currently on a stable anti-HIV drug regimen for at least 8 wks or have not received any anti-HIV drugs for at least 4 wks immediately prior to study entry.
- Safety labs
- No active depression or uncontrolled mental health disorders
A5298 (HPV Vaccine)
Brief Description:
This study is for women who are HIV infected and are aged 27 years or older. Each person in the study will be given the HPV vaccine, or placebo, to see if it prevents persistent HPV infection. The study will also help to determine the acceptability of procedures and treatments associated with anal HPV infection. The participants in the study will have anal HPV DNA testing, oral HPV DNA testing, high-resolution anoscopies, and other tests.
Purpose of this Study:
To learn if the HPV Vaccine prevents persistent anal infection with the four HPV types contained in the vaccine.
Requirements to Enter Study:
- HIV-1-infected women aged 27 years or older with no history of anal, vulvar, cervical, or oropharyngeal cancer
- High-resolution anoscopy performed within 45 days prior to entry with no evidence of anal cancer by anal biopsy or by visual inspection if no biopsy was obtained.
- No prior topical or surgical treatment for internal anal or perianal intraepithelial neoplasia or warts/condyloma within 6 months prior to entry. (Presence of warts/condyloma is not exclusionary.)
- No prior doses of an HPV vaccine.
- Other requirements which your study nurse will discuss with you.
A5303 (Maraviroc)
Brief Description:
A5303 is a study for people who are infected with the R5 type of HIV virus and have never taken HIV medications. Participants will receive either an experimental regimen (darunavir [DRV] + ritonavir [RTV] + maraviroc [MVC] + emtricitabine [FTC] once-daily) or a standard regimen (DRV + RTV + tenofovir [TDF] + FTC once-daily) for 48 weeks.
Purpose of this Study:
The main purpose of the study is to compare the effects of the regimens on bone mineral density (BMD) as measured by a DXA bone scan in patients who have never taken HIV medications.
The study will also compare the effects of the study drug regimens on changes in the immune system and kidney, bone, and neurocognitive function. Safety and tolerability of the study drugs and any changes or resistance that occurs in the HIV virus will also be evaluated.
Requirements to Enter Study:
- HIV-1 infected men and women at least 18 years of age.
- Have not taken HIV medications.
- No resistance to the type (class) of medications provided by the study on a test called a genotype.
- R5 type of HIV virus based on a Trofile test performed at screening.
- HIV viral load (HIV level) currently 1000 copies/mL or higher.
- Never taken bone therapies.
- No history after 18 year of age of fracture of the spine, hip, wrist, or other site thought to be related to osteoporosis or bone fragility.
- No active hepatitis B infection.
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