Clinical Trials

Protocol Title

Treatment

Eligibility

AI424128  –  A Phase IV, Multi-center, Cross-sectional Study to Evaluate the I50L Substitution Among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV).  P.I.:  Jose G. Castro, Nurse: Tom Tanner

This is a cross-sectional multi-center study designed to compare the prevalence of the 150L substitution in various populations experiencing virologic failure on a HAART regimen containing ATV.

1.  Must be on antiretroviral regimen containing ATV at time of screening and the last 6 months. 2. HIV RNA ≥ 1000 copies/mL.

TMX114-TiDP31-C229  –  A Randomized, Open-Label Trial to Compare the Efficacy, Safety and Tolerability of DRV/rtv (800/100 mg) q.d. versus DRV/rtv (600/100 mg) b.i.d. in Early Treatment-experienced HIV-1 Infected Subjects.  P.I.: Dushyantha Jayaweera, Nurse: Sandra Mercado

DRV/rtv (800/100 mg) q.d. versus DRV/rtv (600/100 mg) b.i.d.

Early failure of any ART except Prezista.

NIH  –  True Prevalence of Pre-existing Reverse Transcriptase Inhibitor Resistance in Treatment Naive Individuals Initiating Antiretroviral Therapy. P.I.: Rafael Campo, Nurse: Tom Tanner

None.

1. HIV treatment naive. 2. Three blood draws at three different time points.                                                                                                                                    

GS-US-183-0144  –  A Multi-center, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered with a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults.  PI: Rafael Campo, Nurse: Tom Tanner

Arm 1 – Ritonavir-boosted elvitegravir 150 mg QD (RTV boosted elvitegravir 85 mg QD for subjects taking atazanavir/r or lopinavir/r as part of their BR) + raltegravir placebo BID + BR.  Arm 2 – Raltegravir 400 mg BID + elvitegravir placebo QD + BR .              

1. Plasma HIV-1 RNA  ≥ 1000 copies/mL at screening. 2. Documented resistance. OR At least 6 months experience prior to screening with two or more different classes of antiretrovirals. 3. Stable ARV for at least 30 days prior to screening and remain on screening regimen until baseline.

Pfizer A4001067  –  An International, Multicenter, Prospective Observational Study of the Safety of Maraviroc Used with Optimized Background Therapy in Treatment Experienced HIV-1 Infected Patients. P.I.: Jose G. Castro, Nurse: Tom Tanner

Observational.

Receive appropriate HIV-1 tropism assay for eligibility to receive maraviroc.

Retaining HIV Subjects.  –   P.I.: Allan Rodriguez,  Coordinator: Leah Varga

None.

DCFAR  –  Pathogenesis of HIV/HCV Co-Infection: the Role of Oxidative Stress.  P.I.: Dushyantha Jayaweera, Nurse: Tom Tanner                                                     .

1. HIV/HCV co-infected or HIV mono-infected with HBV infection rules out. HIV mono-infected subjects will have HCV-RNA analysis to rule out HCV infection.   2. HIV/HCV co-infected subjects at the F0, F1, F4 and F5 Ishak score for stage of liver fibrosis as determined by liver biopsy and prior to stating HCV treatment. 3. CD4 count > 350 cells/mL HIV-1 viral load ≤ 400 copies.

NIH  –  Attitudes of Hispanics About Male Circumcision of their Unborn Children.  P.I.: Jose G. Castro, Nurse: TBA

Questionnaires.

TMC114-HIV-3004  –  An Open-Label, Multicenter Trial to Compare the Efficacy, Safety and Tolerability of Prezista/r by Gender and Race when Administered in Combination with an Individually Optimized Background Regimen Over a 48 Week Period.  P.I.: Dushyantha Jawaweera, Nurse: Sandra Mercado

Prezista/r twice daily (600/100 mg)

1. Plasma HIV RNA ≥ 1000 copies/mL. 2. Previous therapy consisting of a PI or NNRTI based HAART regimen of at least 12 weeks. 3. Premenopausal and postmenopausal women.  4. No prior use of Prezista, TMC 125, ENF or TPV.

PO4889  –  14 Vicriviroc in Combination Treatment with an Optimized Regimen in Experienced Subjects (VICTOR-E4: Protocol P04889). P.I.: Allan Rodriguez, Nurse: Tom Tanner

Vicriviroc 30 mg tablet – orally once daily.  Matching placebo table – orally once daily.

1. HIV-1 RNA > 1000 copies/mL within 60 days of randomization either: a. On stable regimen of 3 or more ARVs for at least 4 weeks at time of screening. OR b. Not on any ARVs for ≥ 4 weeks prior to screening. 2. Subjects must be ART class experienced with documented resistance to at leaset 2 of the following: NRTI, NNRTI or PI.                           OR  3. ART experienced ≥ 6 months with at least 2 of the following: NRTI, NNRTI or 2 PIs (excluding low dose ritonavir).                               

TMC278-TiDP6-C215  –  A Phase III, Randomized, Double-Blind Trial of TMC278 25 mg q.d. versus Efavirenz 600 mg q.d. in Combination with a Background Regimen Containing 2 Nucleoside/nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-naive HIV-1 Infected Subjects.  P.I.: Dushyantha Jayaweera Nurse: Sandra Mercado

Randomized to 1:1 ratio to one of two treatment groups: TMC278 (and EFV placebo)  OR  EFV (and TMC278 placebo) each in combination with ABC/3TC or TDF/FTC.

1. Demonstrate sensitivity to ABC and 3TC, AZT and 3TC and/or TDF and FTC. 2. Subjects with ABC in their background regimen are HLA-B*5701 negative.

TMC114HIV4023  –  A Multicenter, Open-label, Randomized Study to Assess the Metabolics, Efficacy and Safety of Once-daily Darunavir versus Atazanavir in HIV-infected Treatment-naive adult patients. P.I.: Dushyantha Jayawerra Nurse: Sandra Mercado

Subjects randomized in a 1:1 ratio to receive DRV/r 800/100 mg q.d. or ATV/r 300/100 mg q.d. administered in combination with a fixed dose background regimen consisting of Truvada (FTC/TDV 200/300 mg).

1. HIV-1 RNA ≥ 1000 copies mL. 2. No previous ARVs for HIV. 3. Any CD4 count.

MC114-HIV-4022  –  Randomized, Open-label, Study of Switch from Lopinavir/ritonavir (LPV/r) of Fosamprenavir/ritonavir (FPV/r) to Either Once Daily Darunavir/ritonavir (DRV/r) (plus Background Nucleoside Reverse Transcriptase Inhibitors) in Patiens Experienceing Triglyceride Elevations While Receiving LPV/r or FPV/r Lopinavir/r of Fosamprenavir/r Switch to Atazanavir/r or Daruavir/r.  P.I.: Dushyantha Jayaweera Nurse: Sandra Mercado

Either on :PV/r or FPV/r as first PI* and ≥ 2 NRTIs for at least 12 weeks with undetectable VL for at least 12 weeks and fasting triglycerides > 200 mg/dL. * Can be on a second PI if reason for switch to LPV/r or FPV/r was not for virologic failure.

1. Currently receiving ARV inclusive of LPV/r or FPV/r and ≥ 2 NRTIs for at least 12 weeks prior to screening. 2. Undetectable VL (<400 copies/mL).  3. No evidence of HIV protease resistance.  4. Currently receiving first PI undless switch to LPV/r or FPV/r was for non-virologic reasons.  5. Fasting triglycerides > 200 mg/dL.

MK-0518-071  –  A Multicenter, Double-blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of Once Daily Raltegravir (MK-0518) versus Efavirenz in Treatment-naive HIV-infected Patients, Each in Combination wiht Truvada.  P.I.: Rafael E. Campo Nurse: Tom Tanner

Group 1: Raltegravir 400 mg PO b.i.d. + placebo to raltegravir PO q.d. + Truvada q.d.   Group 2: Raltegravir 800 PO q.d. + placebo to raltegravir PO q.d. + Truvada q.d.

1. Screening HIV RNA > 5000 copies/mL within 45 days prior to treatment phase. 2. Naive to ARVs.