Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether a combination of raltegravir and darunavir is as effective as standard regimens in the treatment of HIV-infected patients who have not previously used antiretroviral drug (treatment naive)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dallas VA Medical Center
• Collaborators: Merck Sharp & Dohme Corp.; Tibotec Pharmaceutical Limited
• Treatments: Darunavir; Emtricitabine; Raltegravir Potassium; Ritonavir; Tenofovir

Criteria

Inclusion Criteria

• The patient has documented HIV-1 infection.

• The patient is at least 18 years of age.

• Antiretroviral naive, defined as 7 days or less of ARV treatment at any time prior to study entry. HIV viral load greater than 5,000 copies/ml within 90 days of study entry

• Willing to use acceptable forms of contraception

• Parent or guardian willing to provide informed consent, if applicable

• Hepatitis B surface antigen (HBsAg) negative at study entry

Exclusion Criteria

• Patient is current participant in a Raltegravir trial or in trials involving any of the other study medications (Darunavir, Tenofovir or Emtricitabine).

• Immunomodulators (e.g., interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Individuals receiving either stable physiologic glucocorticoid doses, corticosteroids for acute therapy for pneumocystis pneumonia, or a short course (2 weeks or less) of pharmacologic glucocorticoid therapy will not be excluded.

• Known allergy/sensitivity to study drugs or their formulations

• Patient has a condition (including but not limited to active alcohol or drug use) that, in the opinion of the investigator, may interfere with patient adherence or safety

• Patient with acute hepatitis due to any cause or clinically significant chronic liver disease including but not limited to cirrhosis, ascites, encephalopathy, hypoalbuminemia, prolonged PT/PTT and/or esophageal varices.

• Patient has severe renal insufficiency defined as a calculated creatinine clearance at time of screening <30 mL/min, base on Cockcroft/Gault equation which is as follows (and 0.85 X this value for females):

• CrCl (mL/min) = [(140-Age) x Weight (in Kg)]/72 x Serum Creatinine (mg/mL)

• Serious illness requiring systemic treatment or hospitalization. Patients who have completed therapy or are clinically stable on therapy for at least 7 days prior to study entry are not excluded.

• Known clinically relevant cardiac conduction system disease

• Patient requires or is anticipated to require any of the prohibited medications noted in the protocol

• Current imprisonment or involuntary incarceration for psychiatric or physical (e.g., infectious disease) illness

• Pregnancy and Breastfeeding. Women who become pregnant during the study will be required to permanently discontinue their study regimens.