Atazanavir/Ritonavir Maintenance Therapy

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Conditions

HIV Infections

Treatments

Drug: Atazanavir

Drug: Ritonavir

Study type

Interventional

Funder types

NIH

Identifiers

NCT00084019

10096 (Registry Identifier)

ACTG A5201

A5201

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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