Status:
COMPLETED
Atazanavir/Ritonavir Maintenance Therapy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
The expense, difficulty, and long-term adverse events associated with sustained adherence to combination antiretroviral therapy emphasize the need for simpler, alternative treatment strategies for HIV...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00084019
Start Date
July 1 2004
End Date
May 1 2006
Last Update
November 1 2021
Active Locations (12)
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1
Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, United States, 94304-5350
2
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
3
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, United States, 96816
4
Univ. of Iowa Healthcare, Div. of Infectious Diseases
Iowa City, Iowa, United States, 52242