The Verve Study: For HIV+ Individuals Who Have Never Been on Treatment  

What is the purpose of this research?
The purpose of this research is to compare the safety and effectiveness of Viramune immediate release two times per day and Viramune XR (an investigational extended release formulation) once per day. Both are given in combination with a combination pill, Truvada.

What are the treatments for HIV?

Currently HIV is treated using at least 3 different drugs from at least 2 different drug classes. There are currently almost 30 drugs in 5 different drug classes approved by the FDA for the treatment of HIV infection.

How will this study be done?

Approximately 1200 volunteers will take part in this research study. Every participant will be asked to take the HIV study drugs and attend regularly scheduled study-related medical appointments for up to three years. After the study treatment has been completed, each participant will have a follow-up appointment in 1 month.

• All the risks and benefits of participation will be explained to you before you enroll in the study
• A study doctor or study nurse will evaluate your health status to decide if you can participate
• You will be required to sign a consent document if you wish to participate

How can I participate?
You must meet certain standards to participate. You must:

• Never have received HIV treatment
• Males should have a CD4 count less than 400 cells/mL
• Females should have a CD4 count less than 250 cells/mL  

Why should I participate?
By being part of this study you may be helping thousands of HIV infected individuals like yourself. The information obtained from your participation in this study will be used to help determine the best HIV treatment for future patients.

You will be reimbursed for expenses and travel.  

For more information please contact:
(703) 560-4821 or info@careidresearch.com

Gilead Sciences Elvitegravir/Ritonavir vs. Raltegravir

CARE-ID is currently enrolling HIV-1+ infected treatment-experienced adults who are 18 years of age or older to take part in a clinical trial investigating the safety and efficacy of Ritonavir-boosted elvitegravir verses Raltegravir.

Subjects must be:

• Treatment experienced with at least 2-classes of HIV medications
• Naïve to integrase inhibitors
• Viral load >1,000 copies/mL

Study medications, physical examinations and laboratory studies are provided at no cost to the subject, as are the laboratory studies and study visits.

All subjects will receive either elvitegravir/Ritonavir, or Raltegravir in combination with their choice of other antiretrovirals (ARVs).

Each volunteer will receive $30 per completed regular visit.

This study also has an optional pharmacokinetic (drug-level) substudy at Day 28. Subjects remain in the office for 12-hours for multiple blood draws, and return again the next morning for the 24th hour blood draw. They will be reimbursed $200 for completed participation in the sub-study.

For more information please contact:
(703) 560-4821 or info@careidresearch.com

V212-002 Heat-Treated Varicella-Zoster Virus in HIV Infected Volunteers

A Phase I, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults

The proposed indication for the investigational heat-treated, or weakened, varicella-zoster virus (VZV) vaccine is the prevention of herpes zoster (HZ), or Shingles, and HZ-related complications in immunocompromised individuals.

Immunocompromised patients, or people with weakened immune systems, have a higher incidence of HZ, compared with the general population, and are at increased risk for developing severe and life-threatening complications.  In human immunodeficiency virus (HIV)-infected patients with CD4 cell, or T-Cell, counts less than 200, the incidence of HZ is estimated to be 40 to 100 per 1000 people per-year.  ZOSTAVAX™ is currently available for prevention of HZ and its complications, especially HZ-related pain and postherpetic neuralgia (PHN), but only for patients who have intact immune systems.  ZOSTAVAX™, a live attenuated vaccine, is not allowed to be given to patients with CD4 counts that are less than 200.

Prevention of HZ disease in HIV-infected patients with CD4 cells less than 200 represent an area of significant medical need, since these patients cannot receive the live attenuated zoster vaccine.

This study will expand upon the experience of earlier studies with the heat-attenuated, or weakened Varicella-zoster virus vaccine and will provide information on its safety and effectiveness. 

If you are:

• 18 years old or older
• HIV positive
• A CD4 (T-cell) Count of less than 200
• Interested in receiving an investigational vaccine that may protect against the virus that causes Shingles

You may be eligible to participate in a vaccine study conducted with Dr. Donald Poretz and CARE-ID.

Participants will be compensated up to $350.

The NEwArT Study

Join our clinical research study comparing 2 different treatment regimens in individuals who have never taken HIV medications before.

What is the purpose of this research?

There are many medications approved for the treatment of HIV in combination with other HIV medications. The purpose of this research is to compare the safety and effectiveness of Reyataz boosted with Norvir and Viramune, both given in combination with a combination pill, Truvada.

Why conduct this study?

As newer HIV medications are approved by the FDA, it is important to determine the safety and effectiveness of different treatment regimens with existing HIV medications. This information is needed by doctors in order to determine/provide the best treatment for each patient.

What are the treatments for HIV?
Currently HIV is treated using at least 3 different drugs from at least 2 different drug classes. There are currently almost 30 drugs in 4 different drug classes approved by the FDA for the treatment of HIV infection.

How will this study be done?
Approximately 150 volunteers will take part in this research study in the US.

Every participant will be requested to take the HIV study treatment and regularly scheduled study visits for one year. After the study treatment has been completed, each participant will have a follow-up appointment in 1 month.

• All the risks and benefits of participation will be explained to you before you enroll in the study
• A study doctor or study nurse will evaluate your health status to decide if you can participate
• You will be required to sign a consent form if you wish to participate

How can I participate?

You must meet certain standards to participate. You must:

• Never have received HIV treatment (Individuals who have received HIV treatment for less than 10 days can also be considered.)
• Males should have a CD4 count below 400 cells/mL
• Females should have a CD4 count below 250 cells/mL

Why should I participate?

By being part of this study you may be helping thousands of HIV infected individuals in the future. The information obtained from your participation in this study will be used to help determine the best HIV treatment for future patients.

You will be paid for participation in this research study.

For more information, please contact us

at (703) 560-4821

or info@careidresearch.com