Atazanavir/Ritonavir Maintenance Therapy

Not Applicable

Completed

• Conditions: HIV Infections

• Registration Number: NCT00084019
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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 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.

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 infection. Studies have shown that single protease inhibitor (PI) maintenance therapy may provide sufficient virologic suppression while reducing the risk of nucleoside reverse transcriptase inhibitor (NRTI)-associated metabolic complications. However, it is not known whether ritonavir-boosted atazanavir (ATV/RTV) maintenance therapy would be effective in controlling HIV replication in the genital compartments and whether viral load testing by blood collection would be effective in detecting elevated levels of HIV in the genital compartments. This study will determine whether simplified maintenance therapy with ATV/RTV after 48-week virologic suppression will increase the likelihood of virologic failure.

This study will last 54 weeks. Participants will undergo an electrocardiogram (EKG) at screening. At study start, participants will switch from their current PIs to ATV/RTV and stay on their current NRTIs until Week 6, when they will discontinue their NRTIs and remain on a maintenance regimen of ATV/RTV alone for the duration of the study. Study visits will take place at Weeks 3 and 6, then every 4 weeks until Week 30, then every 8 weeks until the end of the study at Week 54. Medication assessment, physical exam, and blood work will occur at each study visit. At Week 30, viral load will be measured in the genital secretions of both male and female study participants.

Study Timeline

• Study First Submitted: 2004-06-04
• Study First Submitted QC: 2004-06-04
• Study First Posted: 2004-06-07
• Study Start: 2004-07
• Study Completion: 2006-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Virologic failure, defined as 2 consecutive viral load measurements of 200 copies/ml or greater, at or before Week 30 (24 weeks on ATV/RTV alone)

Secondary Outcome Measures

Name	Time	Method
total cholesterol, high-density lipoprotein (HDL) cholesterol, calculated low-density lipoprotein (LDL) cholesterol, and triglycerides
time to treatment discontinuation because of toxicity or intolerance
minor PI variants at virologic failure
Grade 3 and 4 laboratory abnormalities and signs and symptoms
virologic failure at or before Week 54
CD4 cell count and percentages at Weeks 30 and 54
detectable viral load in the genital compartment at Week 30
self-reported adherence scores
viral load determined by modified ultrasensitive RT-PCR assay
plasma drug levels characterized by Cmin and AUC

Trial Locations

Locations (12)

University of Pittsburgh CRS; 🇺🇸 Pittsburgh, Pennsylvania, United States

Dallas VAMC; 🇺🇸 Dallas, Texas, United States

University of Colorado Hospital CRS; 🇺🇸 Aurora, Colorado, United States

Stanford AIDS Clinical Trials Unit CRS; 🇺🇸 Palo Alto, California, United States

Univ. of Iowa Healthcare, Div. of Infectious Diseases; 🇺🇸 Iowa City, Iowa, United States

Univ. of Hawaii at Manoa, Leahi Hosp.; 🇺🇸 Honolulu, Hawaii, United States

Weill Cornell Chelsea CRS; 🇺🇸 New York, New York, United States

Chapel Hill CRS; 🇺🇸 Chapel Hill, North Carolina, United States

Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.; 🇺🇸 Omaha, Nebraska, United States

Puerto Rico AIDS Clinical Trials Unit CRS; 🇵🇷 San Juan, Puerto Rico

Cincinnati CRS; 🇺🇸 Cincinnati, Ohio, United States

Duke Univ. Med. Ctr. Adult CRS; 🇺🇸 Durham, North Carolina, United States