Comparative Study of Three NNRTI-Sparing HAART Regimens

Recruiting in Palo Alto (17 mi)

+56 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Raphael Landovitz, MD, MSc

Principal Investigator

UCLA AIDS Prevention & Treatment CTU

Judith Silverstein Currier, MD, MSc

Principal Investigator

UCLA AIDS Prevention & Treatment CTU

Jeffrey L. Lennox, MD

Principal Investigator

Emory HIV/AIDS CTU

Igho Ofotokun, MD

Principal Investigator

Emory HIV/AIDS CTU

Eligibility 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.

Treatment Details

Interventions

• Atazanavir (Protease Inhibitor)
• Darunavir (Protease Inhibitor)
• Emtricitabine/tenofovir disoproxil fumarate (Nucleoside Reverse Transcriptase Inhibitor)
• Raltegravir (Integrase Inhibitor)
• Ritonavir (Pharmacokinetic Enhancer)

Participant Groups

Group I: Arm C: DRV/RTV + FTC/TDF Experimental Treatment 3 Interventions

FTC/TDF, darunavir (DRV), and RTV, orally, once daily.

Group II: Arm B: RAL + FTC/TDF Experimental Treatment 2 Interventions

FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.

Group III: Arm A: ATV/RTV + FTC/TDF Experimental Treatment 3 Interventions

Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Harbor-UCLA Med. Ctr. CRS Torrance, CA

The Ponce de Leon Center CRS Atlanta, GA

Case CRS Cleveland, OH

The Research & Education Group- Portland CRS (31474) Portland, OR

More Trial Locations

Who Is Running the Clinical Trial?

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Lead Sponsor

Trials

103

Patients Recruited

74,200+

AIDS Clinical Trials Group

Lead Sponsor

Trials

101

Patients Recruited

73,600+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3361

Patients Recruited

5,516,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2731

Patients Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA

Industry Sponsor

Trials

15

Patients Recruited

3,100+

Gilead Sciences

Industry Sponsor

Trials

1150

Patients Recruited

878,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4096

Patients Recruited

5,232,000+