Optimizing Treatment for Treatment-Experienced, HIV-Infected People
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Treatment Experienced
Eligibility Criteria
Inclusion Criteria:
- HIV-1 infection
- Triple-class drug experience or resistance. More information on this criterion can be found in the protocol.
- Currently on a failing PI-containing regimen that includes 2 other ARVs with no regimen change for 8 weeks prior to study screening
- HIV viral load of 1000 copies/ml or more
- Hepatitis B surface antigen negative within 90 days of study entry
- Able to obtain NRTIs and ritonavir and have required ARVs at time of starting study intervention
- Willing to use acceptable forms of contraception
- Parent or legal guardian willing to provide consent, if applicable
- CD4 count result from a specimen drawn within 120 days prior to study entry
- If any previous HIV-1 viral co-receptor tropism result is available, then most recent specimen date and the tropism result of that specimen AND specimen date and tropism result of any test with either X4 or D/M result, if different from the first specimen, must be available
Inclusion Criteria continued:
- Receipt of successful phenotype/genotype resistance results within 105 days prior to study treatment intervention assignment
- Study team identification of a study regimen and at least 2 NRTIs for participant to take
- Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
Exclusion Criteria:
- Chronic, active hepatitis B virus infection (hepatitis B surface antigen positive or HBV DNA positive)
- Taking certain medications. More information on this criterion can be found in the protocol.
- Known allergy/sensitivity to components of two or more of the study-provided drugs or their formulations. For maraviroc, this includes hypersensitivity or history of allergy to soy lecithin or peanuts.
- Active drug or alcohol use that, in the opinion of the investigator, may interfere with the study
- Pregnancy or breastfeeding
- Use of any immunomodulator (interferons, interleukins, systemic corticosteroids, or cyclosporine), vaccine, or investigational therapy within 30 days prior to study treatment allocation/assignment
- Require certain medications prohibited with study treatment
- Serious illness requiring systemic treatment or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study treatment allocation are not excluded.
Sites / Locations
- Alabama Therapeutics CRS
- Miller Children's Hosp. Long Beach CA NICHD CRS
- University of Southern California CRS
- Usc La Nichd Crs
- UCLA CARE Center CRS
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
- Stanford AIDS Clinical Trials Unit CRS
- UCSD Antiviral Research Center CRS
- Ucsf Hiv/Aids Crs
- Univ. of California San Francisco NICHD CRS
- University of Colorado Hospital CRS
- Denver Public Health CRS
- Georgetown University CRS (GU CRS)
- Children's National Med. Ctr. ATN CRS
- Howard Univ. Washington DC NICHD CRS
- Pediatric Perinatal HIV Clinical Trials Unit CRS
- The Ponce de Leon Center CRS
- Northwestern University CRS
- Rush University CRS
- Tulane Univ. New Orleans NICHD CRS
- IHV Baltimore Treatment CRS
- Johns Hopkins University CRS
- Massachusetts General Hospital CRS (MGH CRS)
- Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
- Bmc Actg Crs
- Boston Medical Center Ped. HIV Program NICHD CRS
- Beth Israel Deaconess Med. Ctr., ACTG CRS
- Wayne State Univ. CRS
- Henry Ford Hosp. CRS
- Washington University Therapeutics (WT) CRS
- Cooper Univ. Hosp. CRS
- New Jersey Medical School Clinical Research Center CRS
- Rutgers - New Jersey Medical School CRS
- Bronx-Lebanon Hosp. Ctr. CRS
- Weill Cornell Chelsea CRS
- NY Univ. HIV/AIDS CRS
- Nyu Ny Nichd Crs
- Metropolitan Hosp. NICHD CRS
- Columbia P&S CRS
- Columbia IMPAACT CRS
- Harlem ACTG CRS
- Trillium Health ACTG CRS
- Univ. of Rochester ACTG CRS
- Chapel Hill CRS
- Duke Univ. Med. Ctr. Adult CRS
- Cincinnati CRS
- Case Clinical Research Site
- MetroHealth CRS
- Ohio State University CRS
- The Research & Education Group-Portland CRS
- Penn Therapeutics, CRS
- Thomas Jefferson Univ. Med. Ctr. CRS
- University of Pittsburgh CRS
- The Miriam Hospital Clinical Research Site (TMH CRS) CRS
- St. Jude Children's Research Hospital CRS
- Vanderbilt Therapeutics (VT) CRS
- Trinity Health and Wellness Center CRS
- Houston AIDS Research Team CRS
- Texas Children's Hospital CRS
- Virginia Commonwealth Univ. Medical Ctr. CRS
- University of Washington AIDS CRS
- Puerto Rico AIDS Clinical Trials Unit CRS
- University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
- San Juan City Hosp. PR NICHD CRS
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Other
A
B
C
Regimen with higher predicted activity assigned by the study plus at least 2 NRTIs (personalized choice from expert recommendation) for 96 weeks. A 3-4 drug regimen was selected from the drugs listed to the right.
Regimen with higher predicted activity assigned by the study without NRTIs for 96 weeks. A 3-4 drug regimen was selected from the drugs listed to the right.
Regimen with lower predicted activity assigned plus at least 2 NRTIs (personalized choice from expert recommendation) for 96 weeks. A 3-4 drug regimen was selected from the drugs listed to the right.