Atazanavir/Ritonavir Maintenance Therapy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00084019 |
Recruitment Status
:
Completed
First Posted
: June 7, 2004
Last Update Posted
: June 3, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Atazanavir Drug: Ritonavir | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Open-Label, Pilot Trial of Regimen Simplification to Atazanavir/Ritonavir Alone as Maintenance Antiretroviral Therapy After Sustained Virologic Suppression |
Study Start Date : | July 2004 |
Actual Study Completion Date : | May 2006 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084019
United States, California | |
Stanford AIDS Clinical Trials Unit CRS | |
Palo Alto, California, United States, 94304-5350 | |
United States, Colorado | |
University of Colorado Hospital CRS | |
Aurora, Colorado, United States, 80045 | |
United States, Hawaii | |
Univ. of Hawaii at Manoa, Leahi Hosp. | |
Honolulu, Hawaii, United States, 96816 | |
United States, Iowa | |
Univ. of Iowa Healthcare, Div. of Infectious Diseases | |
Iowa City, Iowa, United States, 52242 | |
United States, Nebraska | |
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. | |
Omaha, Nebraska, United States, 68198-9500 | |
United States, New York | |
Weill Cornell Chelsea CRS | |
New York, New York, United States, 10011 | |
United States, North Carolina | |
Chapel Hill CRS | |
Chapel Hill, North Carolina, United States, 27599 | |
Duke Univ. Med. Ctr. Adult CRS | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Cincinnati CRS | |
Cincinnati, Ohio, United States, 45219 | |
United States, Pennsylvania | |
University of Pittsburgh CRS | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, Texas | |
Dallas VAMC | |
Dallas, Texas, United States, 75216 | |
Puerto Rico | |
Puerto Rico AIDS Clinical Trials Unit CRS | |
San Juan, Puerto Rico, 00935 |
Study Chair: | Susan Swindells, MD | University of Nebraska |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00084019 History of Changes |
Other Study ID Numbers: |
A5201 10096 ( Registry Identifier: DAIDS ES ) ACTG A5201 |
First Posted: | June 7, 2004 Key Record Dates |
Last Update Posted: | June 3, 2014 |
Last Verified: | June 2014 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Atazanavir Sulfate |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |