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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by (Responsible Party): | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00084019 |
Purpose
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 | Intervention |
|---|---|
|
HIV Infections |
Drug: Atazanavir Drug: Ritonavir |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
| Enrollment: | 36 |
| Study Completion Date: | May 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford CRS | |
| Stanford, California, United States, 94305-5107 | |
| United States, Colorado | |
| University of Colorado Hospital CRS | |
| Aurora, Colorado, United States, 80262-3706 | |
| United States, Hawaii | |
| Univ. of Hawaii at Manoa, Leahi Hosp. | |
| Honolulu, Hawaii, United States, 96816-2396 | |
| United States, Iowa | |
| Univ. of Iowa Healthcare, Div. of Infectious Diseases | |
| Iowa City, Iowa, United States, 52242-1201 | |
| United States, Nebraska | |
| Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr. | |
| Omaha, Nebraska, United States, 68198-5130 | |
| United States, New York | |
| Cornell CRS | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Unc Aids Crs | |
| Chapel Hill, North Carolina, United States, 27514 | |
| Duke Univ. Med. Ctr. Adult CRS | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Univ. of Cincinnati CRS | |
| Cincinnati, Ohio, United States, 45267-0405 | |
| United States, Pennsylvania | |
| Pitt CRS | |
| Pittsburgh, Pennsylvania, United States, 15213-2582 | |
| United States, Texas | |
| Dallas VAMC | |
| Dallas, Texas, United States, 75216 | |
| Puerto Rico | |
| Puerto Rico-AIDS CRS | |
| San Juan, Puerto Rico, 00936-5067 | |
| Study Chair: | Susan Swindells, MD | University of Nebraska |
More Information
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00084019 History of Changes |
| Other Study ID Numbers: | A5201, 10096, ACTG A5201 |
| Study First Received: | June 4, 2004 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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Treatment Experienced |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Ritonavir |
Atazanavir HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses |