Atazanavir/Ritonavir Maintenance Therapy

Completed · Not applicable

Conditions studied: HIV Infections

In brief

Long-term side effects, the expense of medications, and the difficulty of taking medications continuously for long periods of time are all problems with complicated anti-HIV drug regimens. The purpose of this study is to determine whether two drugs, atazanavir (ATV) and ritonavir (RTV), will control HIV infection when taken together without any other anti-HIV drugs after 48 weeks of viral suppression. Hypothesis: Simplified maintenance therapy with ATV and RTV alone after virologic suppression does not markedly increase the risk of virologic failure.

Key facts

Study ID

NCT00084019

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

Starts

2004-07-01

Expected to finish

2006-05-01

Last updated by the study team

2021-11-01

Who can join

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

You may qualify if…

• HIV infected
• On first antiretroviral regimen, including at least 2 NRTIs and 1 PI, for at least 48 weeks immediately prior to study entry
• CD4 count of 250 cells/mm3 or greater
• Viral load less than 50 copies/ml within 30 days prior to entry
• Willing to use acceptable methods of contraception

You may not qualify if…

• Current or prior use of an NNRTI
• Certain PI mutations
• Hepatitis B infection within 90 days prior to study entry
• Certain therapies or medications within 30 days prior to study entry
• Heartbeat abnormalities or symptoms potentially related to heart block, such as unexplained fainting, dizziness, or palpitations, occurring within 180 days prior to study entry
• Drug or alcohol use or dependence that would interfere with adherence to the study requirements
• Serious illness requiring systemic treatment or hospitalization until the participant either completes therapy or has been clinically stable on therapy for at least 14 days prior to study entry
• Allergy or sensitivity to study medications or their formulations
• Current involuntarily incarceration for treatment of either a mental or physical illness
• Treatment for an active AIDS-defining opportunistic infection within 30 days prior to screening
• Pregnant or breastfeeding

Where it is running

• Stanford AIDS Clinical Trials Unit CRS — Palo Alto, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
• Univ. of Iowa Healthcare, Div. of Infectious Diseases — Iowa City, Iowa, United States
• Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. — Omaha, Nebraska, United States
• Weill Cornell Chelsea CRS — New York, New York, United States
• Chapel Hill CRS — Chapel Hill, North Carolina, United States
• Duke Univ. Med. Ctr. Adult CRS — Durham, North Carolina, United States
• Cincinnati CRS — Cincinnati, Ohio, United States
• University of Pittsburgh CRS — Pittsburgh, Pennsylvania, United States
• Dallas VAMC — Dallas, Texas, United States
• Puerto Rico AIDS Clinical Trials Unit CRS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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