Comparative Study of Three NNRTI-Sparing HAART Regimens

Completed · Phase 3

Conditions studied: HIV Infection

In brief

The U.S. Department of Health and Human Services (HHS) guidelines recommend that HIV infected patients who have never received anti-HIV therapy be treated with a triple drug regimen. The most commonly prescribed and successful regimen contains the medication efavirenz (EFV). However, this regimen may not be an option for everyone, hence alternative regimens are needed. This study was designed to look at how well different combinations of anti-HIV drugs work to decrease the amount of HIV in the blood (viral load) of and allow immune system recovery in people who have never received anti-HIV therapy. This study also examined drug tolerability and safety for the various drug combinations.

Key facts

Study ID

NCT00811954

Run by

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

People needed

1814

Starts

2009-05-01

Expected to finish

2013-06-01

Last updated by the study team

2014-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infected
• No evidence of any exclusionary mutations defined as any major NRTI or PI resistance-associated mutation on any genotype or evidence of significant NRTI or PI resistance on any phenotype performed at any time prior to study entry. NNRTI-associated resistance mutations are not excluded. More information on this criterion can be found in the study protocol.
• No prior anti-HIV therapy. More information on this criterion can be found in the study protocol.
• Viral load is 1000 copies/mL or higher, as measured within 90 days prior to study entry
• Certain laboratory values obtained within 60 days prior to study entry
• Ability to obtain RTV by prescription
• Completed cardiovascular risk assessment. More information on this criterion can be found in the study protocol.
• Must agree to use acceptable forms of contraception while receiving study drugs and for 6 weeks after stopping the medications. More information on this criterion is available in the protocol.
• Negative pregnancy test within 72 hours before initiating antiretroviral medication
• Participating in research at any AIDS Clinical Trial Group (ACTG) clinical research site or select International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) group sites
• Ability and willingness of subject or legal guardian/representative to give written informed consent

You may not qualify if…

• Use of immunomodulators, HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Those using stable physiologic glucocorticoid doses, a short course of pharmacologic glucocorticoid, corticosteroids for acute therapy treating an opportunistic infection, inhaled or topical corticosteroids, or granulocyte-colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) will not be excluded.
• Known allergy or sensitivity to study drugs or their ingredients. A history of sulfa allergy is not excluded.
• Any condition that, in the opinion of the investigator, would compromise the participant's ability to participate in the study
• Serious illness requiring systemic treatment and/or hospitalization until participant either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 7 days prior to study entry
• Requirement for any current medications that are prohibited with any study drugs
• Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness
• Any prior use of entecavir for treatment of hepatitis B for greater than 8 weeks while the participant was known to be HIV infected
• Presence of decompensated cirrhosis
• Pregnant or breastfeeding

Where it is running

• Miller Children's Hospital — Long Beach, California, United States
• USC CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Stanford CRS — Palo Alto, California, United States
• Ucsd, Avrc Crs — San Diego, California, United States
• Ucsf Aids Crs — San Francisco, California, United States
• Harbor-UCLA Med. Ctr. CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Denver Public Health CRS — Denver, Colorado, United States
• Georgetown University CRS (GU CRS) — Washington D.C., District of Columbia, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• South Florida Childrens Diagnostic & Treatment Cen (5055) — Fort Lauderdale, Florida, United States
• University of Florida Jacksonville (5051) — Jacksonville, Florida, United States
• Univ. of Miami AIDS CRS — Miami, Florida, United States
• The Ponce de Leon Center CRS — Atlanta, Georgia, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
• Tulane University New Orleans NICHD CRS (5095) — New Orleans, Louisiana, United States
• IHV Baltimore Treatment CRS — Baltimore, Maryland, United States
• Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
• Massachusetts General Hospital CRS — Boston, Massachusetts, United States
• Brigham and Women's Hosp. ACTG CRS — Boston, Massachusetts, United States
• Bmc Actg Crs — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States
• Alabama Therapeutics CRS — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.