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NIAID HIV and Emerging Infectious Diseases Program

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CONQUER Study

Study name

Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected with HIV-HCV

Study number

14-CC-0065

Goal of Study

You are being asked to participate in this study because you have HIV infection and you have liver disease caused by infection with the hepatitis C virus (HCV). Asunaprevir (ASV) and daclatasvir (DCV) are new oral medications being developed for the treatment of HCV infection. They are still being researched and are not approved by the Food and Drug Administration (FDA). This combination of Asunaprevir (ASV) and daclatasvir (DCV) has never been given to individuals with HIV and HCV infection. The purpose of this study is to determine whether ASV in combination with DCV for 24 weeks can be safe and effective for treating HCV infection in people who also have HIV infection.

ASV and DCV work by blocking the HCV from dividing in your body. These drugs have been used along with other medications commonly used to treat HCV such as interferon (IFN) and ribavirin (RBV). As of October 2013, more than 1000 healthy volunteers, as well as people with HCV, have taken this combination of drugs as part of research studies. When used with IFN and RBV, these drugs seem to be very effective in eliminating HCV from the body. However, IFN (given as weekly injection) and RBV (pills taken twice a day) are associated with several serious side effects. The development of drugs that may cure HCV infection without using IFN or RBV would be extremely beneficial for the large number of patients infected with HCV.

Study regimen

This study will enroll 20 people who have both HIV and HCV type 1b. Once enrolled you would receive 24 weeks of ASV and DCV. We do not yet know for sure if we can treat the difficult cases of HCV, such a type 1b, seen in people who also have HIV with pills alone, instead of the usual combination of pills and IFN injections.

One ASV (100 mg pill) will be taken twice a day and one 60 mg pill of DCV will be taken once a day, for a total of 3 pills per day. Both drugs will be provided by the manufacturer, Bristol-Myers Squibb, Inc. Participants will be followed during the treatment and for 48 weeks afterwards. After starting the study drugs, if you have to stop them for any reason, you will be offered treatment for HCV (which will contain interferon, RBV, and another drug that blocks HCV called HCV protease inhibitors) under another clinical study, should you choose to take part.

Your participation in the study involves multiple visits to the NIH only, or the NIH and the DC community clinics over a period of 1 year and 5 months from the start of study treatment. In general, each visit will require collection of blood and urine to be used for safety labs (blood counts, blood clotting tests, kidney function, muscle and liver tests, blood minerals, and electrolytes), as well as labs to determine the amount of HCV in your blood (HCV viral load), levels of the study drugs ASV & DCV, your CD4 count, and your HIV viral load. All these tests are routine for patients with infections like yours, but we will need to do them much more often. A liver biopsy or FibroTest®, which is explained below, will be required prior to the start of the study if you have not had one within 3 years.

You may be offered an optional liver biopsy prior to start of study treatment and again at the end of study treatment to help us learn who may or may not respond well to these drugs. We will explain in great detail the process involved, and the risks. You may need a liver ultrasound or other imaging before a liver biopsy. At the time of liver biopsy, you will sign another consent that will explain the procedure and risks in greater detail. Volunteer compensation and study medications will be provided.

Eligibility Criteria

  • Age 18 years or older with documented HIV and HCV co-infection
  • Have not used HIV medications in the past 8 weeks, OR your only HIV medications are Isentress and Truvada; OR your only HIV medications are Isentress and Epzicom; OR if you are not on either of these regimens, you and your doctor would agree to switch you to one of these regimens for the duration of the study
  • Your CD4 t-cell count is at least 500, and your HIV viral load is <500 if you are not on HIV medications; if you are on HIV medications, your CD4 is >100 and viral load is <50
  • Are not pregnant or breast-feeding
  • Willing to either practice sexual abstinence or use a barrier method of contraception throughout the study and for 30 days from last study medication dose
  • Have HCV Genotype 1b
  • Have adequate veins for access to blood draws
  • Have a Primary Care Physician
  • Have no other significant illnesses that may interfere with study treatment
  • Have no current substance abuse that is likely to interfere with study compliance
  • Willing to give informed consent and ability to comply with study requirements

Last Updated May 07, 2014