Comparative Study of Three NNRTI-Sparing HAART Regimens

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Clinical Trials Group
• Collaborators: Bristol-Myers Squibb; Gilead Sciences; Merck Sharp & Dohme Corp.; National Institute of Allergy and Infectious Diseases (NIAID); Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
• Treatments: Atazanavir Sulfate; Darunavir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Protease Inhibitors; Raltegravir Potassium; Ritonavir; Tenofovir

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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