The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.  Listing a study does not mean it has been evaluated by the U.S. Federal Government. 
Read our disclaimer for details. 

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)

Time from randomization to virologic failure (HIV viral load of 1,000 copies/ml or greater at or after Week 16 and before Week 24, or two consecutive HIV viral load of 50 copies/ml or greater at or after Week 24) [ Time Frame: Week 24 ]

Choosing to participate in a study is an important personal decision.  Talk with your doctor and family members or friends about deciding to join a study.  To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.  For general information, Learn About Clinical Studies. 

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

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):