Circle Medical, LLC

153 East Avenue, Suite #32
Norwalk, CT  06851

Dr. Gary Blick, M.D., A.A.H.I.V.S.

Age / Gender Requirements

Regimen

Entrance Criteria

Details

CD4 Count

Viral Load

Previous HIV Treatment

Age ≥ 18 years; males and non-pregnant females; must agree to utilize highly effective contraception from screening until 30 days following the last dose of study drugs.

Must be eligible to receive one of the fully-active ritonavir-boosted-protease inhibitors (based on the results of screening phenotype analysis), an allowed second agent, and either Elvitegravir (GS 9137) or Raltegravir.

No entrance criteria

Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening.

1) Documented resistance or at least 6 months experience prior to screening with two or more different classes of antiretroviral agents.

2) Stable ARV regimen for at least 30 days prior to screening and must remain on screening regimen until the Baseline visit.

3) Treatment naïve to integrase inhibitors.

1) Study medications, physical examinations and laboratory testing will be provided at no cost to the subject.

2) Minimum length of study: 48 weeks

3) After 48 weeks, study visits may continue every 8 weeks until the study is completed.

Age / Gender Requirements

Regimen

Entrance Criteria

Details

CD4 Count

Viral Load

Previous HIV Treatment

Age ≥ 18 years; males or non-pregnant, non-lactating females; must agree to utilize highly effective contraception from screening until 30 days following the last dose of study drugs.

Based on randomization:

Arm 1:  will switch from their current Epzicom to Truvada, administered as one tablet, once daily for 48 weeks.

Arm 2:  will continue taking Epzicom, administered as one tablet, once daily for 48 weeks.

In both arms, the current ritonavir-boosted protease inhibitor will be continued unchanged through the 48 weeks of the study.

No entrance criteria

Two consecutive plasma HIV-1 RNA concentration < 50 copies/mL to ensure that the subject was virologically suppressed for at least 3 months prior to study.

1) HIV-1 infected subjects currently receiving a ritonavir-boosted protease inhibitor and fixed-dose Epzicom (ABC/3TC) regimen for ≥ 6 months.

2)  HIV infection as documented by a validated HIV-antibody ELISA and confirmed by one other method designated by the protocol.

1)Study length: 48 weeks

2) Physical examinations and laboratory testing will be provided at no cost to the subject.

3) If subject randomized to switch from Epzicom to Truvada, Gilead will provide Truvada free of charge, during participation in the study.

4) Post baseline/enrollment visits (total of five) are compensated @ $25 each upon completion of study.

Age / Gender Requirements

Regimen

Entrance Criteria

Details

CD4 Count

Viral Load

Previous HIV Treatment

Age ≥ 18 years; males or non-pregnant, non-lactating females.

Subjects may or may not receive maraviroc in combination with an optimized background antiretroviral therapy regimen, prescribed by the enrolling physician according to the local standard of care of HIV infected patients.

No entrance criteria

No entrance criteria

1) Subject cannot be a recipient of a small molecule CCR5 inhibitor other than maraviroc.)

2) Subject must receive an appropriate HIV-1 tropism assay as a screening for eligibility to receive maraviroc.

1) Study length: all subjects will be followed for up to 5 years after enrollment.

2) The cost of the initial HIV-tropism assay will be covered by Pfizer.

3) Subjects will obtain commercially available drugs as they would in routine clinical practice.

4) Subject must provide signed and dated informed consent to allow the enrolling physician access to medical, hospital and vital statistics records as appropriate.

 To Be Enrolling Soon:

Age / Gender Requirements

Regimen

Entrance Criteria

Details

CD4 Count

Viral Load

Previous HIV Treatment

Age; at least 18 years; males or non-pregnant females.

Arm 1: maraviroc + atazanavir/tironavir, once daily

Arm 2: atazanavir/ritonavir + emtricitabine/tenofovir, once daily

CD4 count ≥ 100 cells/mm3 at screening

HIV-1 RNA viral load of ≥ 1,000 copies/mL measured at screening visit

1) Must be treatment naïve, HIV-infected; no prior treatment with any other HIV antiretroviral therapy for more than 14 days at any time.
 

2) Have only R5 HIV-1 verified at screening.

1) Length of study: 48 weeks

2) Sponsor will provide maraviroc and other study drugs until the end of the study or early termination.

3) Physical examinations and laboratory testing will be provided at no cost to the subject.

* Note: This listing is simply an overview of current ongoing study protocol criteria. For full details, please call CIRCLE Medical @ 203-852-9525 and ask to speak with a Study Coordinator. Fulfillment of the study criteria listed does not guarantee enrollment into a clinical study.  Each participant must be screened individually for qualifications.