Atazanavir/Ritonavir Maintenance Therapy

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Atazanavir Sulfate; Ritonavir

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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