"The Once A Day Protease Inhibitor Regimens"
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ClinicalTrials.gov Identifier: NCT00242216 |
Recruitment Status
:
Completed
First Posted
: October 19, 2005
Results First Posted
: October 17, 2013
Last Update Posted
: January 15, 2014
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Atazanavir (ATV) and fosamprenavir (fAPV) are new protease inhibitors that can be administered once-a-day and boosted with ritonavir (r). Prior studies have demonstrated that both are effective in treatment of ARV-naïve HIV-infected people. This study was designed to demonstrate if a HAART regimen containing ATV/r is not inferior to a HAART regimen containing fAPV/r, in ARV-naïve patients over a 96-week period.
This is a phase IV, single center, randomized, open label, 2-arm clinical trial in ARV therapy-naïve patients with HIV-1 RNA >1,000 copes/mL and CD4 cell count <350 cells/mm3. Patients will be randomized to receive tenofovir and emtricitabine plus either ATV (300mg qd) and ritonavir (100mg qd) or fAPV (1400mg qd) and ritonavir (200mg qd).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: ritonavir-boosted atazanavir Drug: ritonavir-boosted fosamprenavir | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | "PIQD: The Once a Day Protease Inhibitor Regimens." Ritonavir Boosted Atazanavir vs. Ritonavir Boosted Fosamprenavir Used in Combination With Tenofovir and Emtricitabine in HIV-1 Infected Antiretroviral Treatment-Naïve Patients. |
Study Start Date : | May 2004 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Atazanavir oral once daily
HIV treatment
|
Drug: ritonavir-boosted atazanavir
100 mg ritonavir plus 300 mg atazanavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
Other Name: Reyataz plus Norvir
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Active Comparator: Fosamprenavir oral once daily
HIV treatment
|
Drug: ritonavir-boosted fosamprenavir
100 mg ritonavir plus 1,400 mg fosamprenavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
Other Name: Lexiva plus Norvir
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- Proportion of Patient With Viral Load Less Than 400 Copies/mL [ Time Frame: 24 weeks ]
- CD4 Cell Count Change From Baseline During Treatment. [ Time Frame: 24 weeks. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years of age or older.
- Patient agrees to participate in the study by giving written informed consent.
- Documentation of HIV infection.
- No prior treatment with any anti-retroviral agent.
- CD4 cell count < 350 cells x mm3 or with an AIDS defining condition.
- Viral load > 1,000 copies/mL
Exclusion Criteria:
- Less than 18 years old.
- Current pregnancy or breastfeeding.
- Any previous antiretroviral regimen.
- Severe hepatic impairment that precludes the use of either study drug. This will be defined as any laboratory value of Grade 3 or 4 on the ACTG scale.
- Use of any contra-indicated medication as defined in the package insert for each drug.
- Any condition that, in the judgment of the investigator, precludes successful participation in the study.

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): NCT00242216
United States, Texas | |
Thomas Street Health Center | |
Houston, Texas, United States, 77009 |
Principal Investigator: | Roberto C Arduino, MD | The University of Texas Health Science Center, Houston |
Publications of Results:
Other Publications:
Responsible Party: | Roberto Arduino, Professor - Internal Medicine, The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00242216 History of Changes |
Other Study ID Numbers: |
HSC-MS-03-315 |
First Posted: | October 19, 2005 Key Record Dates |
Results First Posted: | October 17, 2013 |
Last Update Posted: | January 15, 2014 |
Last Verified: | December 2013 |
Keywords provided by Roberto Arduino, The University of Texas Health Science Center, Houston:
HIV-1 infected people Antiretroviral treatment-naïve Atazanavir Fosamprenavir ARV Treatment Naive |
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 Fosamprenavir |
Tenofovir Emtricitabine 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 Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |