HIV InfectionsPhase 4NCT00242216
"The Once A Day Protease Inhibitor Regimens"
A Phase 4 study testing ritonavir-boosted atazanavir and ritonavir-boosted fosamprenavir in people with HIV Infections, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- ritonavir-boosted atazanavir and ritonavir-boosted fosamprenavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Mar 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the detailed description
Over the past decade, there have been significant advances toward fighting the progression of HIV disease. Current treatment strategies consist of utilization of potent combination antiretroviral therapy to suppress HIV replication below detectable limits limiting the potential for the emergence of resistant viruses, boosting CD4 cell counts and thereby delaying disease progression. Treatment of HIV-1 infection with Highly Active Antiretroviral Therapy (HAART) regimens containing a protease inhibitor (PI) and two nucleoside reverse transcriptase inhibitor (NRTIs) has been shown to prolong survival and decrease disease progression. Despite these potent antiretroviral agents, current available therapies continue to fail in some patients. Poor adherence to complex treatment regimens remains a significant cause of suboptimal viral suppression leading to emerge of resistant virus. Atazanavir and fosamprenavir were recently FDA approved protease inhibitors. The efficacy and safety profile of these two drugs have been established in clinical trials enrolling antiretroviral therapy naïve and protease inhibitor experienced patients. Atazanavir and fosamprenavir are the only protease inhibitors approved for a once a day regimen and this may set a new standard for treatment of antiretroviral therapy naïve HIV infected patients. Adherence to the medicines, a key component of treatment success, could be significantly improved by using these once daily regimens. However, no head-to-head trials comparing the safety and efficacy of fosamprenavir and atazanavir have been published. This prospective, randomized, open label 2-arm study will compare these two protease inhibitors for therapy of antiretroviral treatment-naïve HIV-infected patients. Patients who are successfully screened for eligibility will be randomized to receive tenofovir and emtricitabine plus either atazanavir (300mg qd) and ritonavir (100mg qd) or fosamprenavir (1400mg qd) and ritonavir (200mg qd). Participants will undergo assessment on day 1 and attend study visits at weeks 6, 12 and every 3 months until the completion of the study on week 96. "Antiretroviral Medication Self-Report" and "3-Day HIV Medication Self-Report" questionnaires will be applied at weeks 6, 12 and every 3 month, thereafter, until week 96. "Changes in Body Appearance" questionnaire will be applied at baseline and weeks 24, 48, 72, and 96.
- Conditions
- HIV Infections
- Being tested
- ritonavir-boosted atazanavir, ritonavir-boosted fosamprenavir
- Keywords
- HIV-1 infected people, Antiretroviral treatment-naïve, Atazanavir, Fosamprenavir, ARV Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ritonavir-boosted atazanavirDrug
Also called Reyataz plus Norvir
100 mg ritonavir plus 300 mg atazanavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
ritonavir-boosted fosamprenavirDrug
Also called Lexiva plus Norvir
100 mg ritonavir plus 1,400 mg fosamprenavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.
| Study group | Role | What they receive |
|---|---|---|
| Atazanavir oral once daily | Active comparator | HIV treatment Receives: Drug: ritonavir-boosted atazanavir |
| Fosamprenavir oral once daily | Active comparator | HIV treatment Receives: Drug: ritonavir-boosted fosamprenavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patient With Viral Load Less Than 400 Copies/mL
Measured: 24 weeks
Secondary outcomes (1)
CD4 Cell Count Change From Baseline During Treatment.
Measured: 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startMay 2004
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Arduino, The University of Texas Health Science Center, Houston
- Investigators
- Roberto C Arduino, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242216
- Sponsor's protocol ID
- HSC-MS-03-315
- Status last verified
- Dec 2013
- First submitted
- 18 Oct 2005
- Last updated
- 15 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Murphy RL, Sanne I, Cahn P, Phanuphak P, Percival L, Kelleher T, Giordano M. Dose-ranging, randomized, clinical trial of atazanavir with lamivudine and stavudine in antiretroviral-naive subjects: 48-week results. AIDS. 2003 Dec 5;17(18):2603-14. doi: 10.1097/00002030-200312050-00007.
PubMed 14685054Sax PE. Meeting notes from the 2nd International AIDS Society Conference on HIV Pathogenesis and Treatment. Atazanavir in treatment-experienced patients. AIDS Clin Care. 2003 Sep;15(9):78.
PubMed 14666914Bayes M, Rabasseda X, Prous JR. Gateways to clinical trials. Methods Find Exp Clin Pharmacol. 2003 Jul-Aug;25(6):483-506.
PubMed 12949633Goldsmith DR, Perry CM. Atazanavir. Drugs. 2003;63(16):1679-93; discussion 1694-5. doi: 10.2165/00003495-200363160-00003.
PubMed 12904086Rodriguez-French A, Boghossian J, Gray GE, Nadler JP, Quinones AR, Sepulveda GE, Millard JM, Wannamaker PG. The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients. J Acquir Immune Defic Syndr. 2004 Jan 1;35(1):22-32. doi: 10.1097/00126334-200401010-00003.
PubMed 14707788SOLO trial results released. AIDS Patient Care STDS. 2003 Feb;17(2):95. doi: 10.1089/108729103321150827. No abstract available.
PubMed 12639292Falcoz C, Jenkins JM, Bye C, Hardman TC, Kenney KB, Studenberg S, Fuder H, Prince WT. Pharmacokinetics of GW433908, a prodrug of amprenavir, in healthy male volunteers. J Clin Pharmacol. 2002 Aug;42(8):887-98. doi: 10.1177/009127002401102803.
PubMed 12162471Vierling P, Greiner J. Prodrugs of HIV protease inhibitors. Curr Pharm Des. 2003;9(22):1755-70. doi: 10.2174/1381612033454441.
PubMed 12871195Mannheimer SB, Matts J, Telzak E, Chesney M, Child C, Wu AW, Friedland G; Terry Beirn Community Programs for Clinical Research on AIDS. Quality of life in HIV-infected individuals receiving antiretroviral therapy is related to adherence. AIDS Care. 2005 Jan;17(1):10-22. doi: 10.1080/09540120412331305098.
PubMed 15832830Holmes A, Lucke J, Maghidman S, Fernandez-Bussy S, Barnett B, Arduino R. Tenofovir associated nephrotoxicity is dose-dependent ritonavir administration a co-factor? XVI International AIDS Conference. Toronto, Canada. August 13-18, 2006. Abstract TUPE0085.
Bell TK, Holmes A, McCormack OE, Barnett BJ, Arduino RC. Changing Genotypic Resistance Patterns and Demographics of Antiretroviral-Naïve HIV Patients in Houston: 1999-2006. 44th Annual Meeting of the Infectious Diseases Society of America (IDSA). Toronto, Canada. October 12-15, 2006. Abstract 975.
Holmes A, Bell T, Barnett B, Arduino R. Emerging resistance mutations in once-daily ritonavir-boosted protease inhibitor-containing antiretroviral regimens. 44th Annual Meeting of the Infectious Diseases Society of America (IDSA). Toronto, Canada. October 12-15, 2006. Abstract 973.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00242216
- Acronym / sponsor ID
- HSC-MS-03-315
- Conditions
- HIV Infections
- Keywords
- HIV-1 infected people, Antiretroviral treatment-naïve, Atazanavir, Fosamprenavir, ARV Treatment Naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Oct 2005 (estimated)
- Results
- Posted 17 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Over the past decade, there have been significant advances toward fighting the progression of HIV disease. Current treatment strategies consist of utilization of potent combination antiretroviral therapy to suppress HIV replication below detectable limits limiting the potential for the emergence of resistant viruses, boosting CD4 cell counts and thereby delaying disease progression. Treatment of HIV-1 infection with Highly Active Antiretroviral Therapy (HAART) regimens containing a protease inhibitor (PI) and two nucleoside reverse transcriptase inhibitor (NRTIs) has been shown to prolong survival and decrease disease progression. Despite these potent antiretroviral agents, current available therapies continue to fail in some patients. Poor adherence to complex treatment regimens remains a significant cause of suboptimal viral suppression leading to emerge of resistant virus. Atazanavir and fosamprenavir were recently FDA approved protease inhibitors. The efficacy and safety profile of these two drugs have been established in clinical trials enrolling antiretroviral therapy naïve and protease inhibitor experienced patients. Atazanavir and fosamprenavir are the only protease inhibitors approved for a once a day regimen and this may set a new standard for treatment of antiretroviral therapy naïve HIV infected patients. Adherence to the medicines, a key component of treatment success, could be significantly improved by using these once daily regimens. However, no head-to-head trials comparing the safety and efficacy of fosamprenavir and atazanavir have been published. This prospective, randomized, open label 2-arm study will compare these two protease inhibitors for therapy of antiretroviral treatment-naïve HIV-infected patients. Patients who are successfully screened for eligibility will be randomized to receive tenofovir and emtricitabine plus either atazanavir (300mg qd) and ritonavir (100mg qd) or fosamprenavir (1400mg qd) and ritonavir (200mg qd). Participants will undergo assessment on day 1 and attend study visits at weeks 6, 12 and every 3 months until the completion of the study on week 96. "Antiretroviral Medication Self-Report" and "3-Day HIV Medication Self-Report" questionnaires will be applied at weeks 6, 12 and every 3 month, thereafter, until week 96. "Changes in Body Appearance" questionnaire will be applied at baseline and weeks 24, 48, 72, and 96.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atazanavir oral once daily | Active comparator | Drug: ritonavir-boosted atazanavirHIV treatment |
| Fosamprenavir oral once daily | Active comparator | Drug: ritonavir-boosted fosamprenavirHIV treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ritonavir-boosted atazanavirAlso: Reyataz plus Norvir100 mg ritonavir plus 300 mg atazanavir in combination with tenofovir-emtricitabine fixed dose combination given once daily. | Drug | Atazanavir oral once daily |
| ritonavir-boosted fosamprenavirAlso: Lexiva plus Norvir100 mg ritonavir plus 1,400 mg fosamprenavir in combination with tenofovir-emtricitabine fixed dose combination given once daily. | Drug | Fosamprenavir oral once daily |
Primary outcome
Proportion of Patient With Viral Load Less Than 400 Copies/mL
Time frame: 24 weeks
1 secondary outcome
CD4 Cell Count Change From Baseline During Treatment.
Time frame: 24 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14685054Murphy RL, Sanne I, Cahn P, Phanuphak P, Percival L, Kelleher T, Giordano M. Dose-ranging, randomized, clinical trial of atazanavir with lamivudine and stavudine in antiretroviral-naive subjects: 48-week results. AIDS. 2003 Dec 5;17(18):2603-14. doi: 10.1097/00002030-200312050-00007.
- Background: PubMed 14666914Sax PE. Meeting notes from the 2nd International AIDS Society Conference on HIV Pathogenesis and Treatment. Atazanavir in treatment-experienced patients. AIDS Clin Care. 2003 Sep;15(9):78.
- Background: PubMed 12949633Bayes M, Rabasseda X, Prous JR. Gateways to clinical trials. Methods Find Exp Clin Pharmacol. 2003 Jul-Aug;25(6):483-506.
- Background: PubMed 12904086Goldsmith DR, Perry CM. Atazanavir. Drugs. 2003;63(16):1679-93; discussion 1694-5. doi: 10.2165/00003495-200363160-00003.
- Background: PubMed 14707788Rodriguez-French A, Boghossian J, Gray GE, Nadler JP, Quinones AR, Sepulveda GE, Millard JM, Wannamaker PG. The NEAT study: a 48-week open-label study to compare the antiviral efficacy and safety of GW433908 versus nelfinavir in antiretroviral therapy-naive HIV-1-infected patients. J Acquir Immune Defic Syndr. 2004 Jan 1;35(1):22-32. doi: 10.1097/00126334-200401010-00003.
- Background: PubMed 12639292SOLO trial results released. AIDS Patient Care STDS. 2003 Feb;17(2):95. doi: 10.1089/108729103321150827. No abstract available.
- Background: PubMed 12162471Falcoz C, Jenkins JM, Bye C, Hardman TC, Kenney KB, Studenberg S, Fuder H, Prince WT. Pharmacokinetics of GW433908, a prodrug of amprenavir, in healthy male volunteers. J Clin Pharmacol. 2002 Aug;42(8):887-98. doi: 10.1177/009127002401102803.
- Background: PubMed 12871195Vierling P, Greiner J. Prodrugs of HIV protease inhibitors. Curr Pharm Des. 2003;9(22):1755-70. doi: 10.2174/1381612033454441.
- Background: PubMed 15832830Mannheimer SB, Matts J, Telzak E, Chesney M, Child C, Wu AW, Friedland G; Terry Beirn Community Programs for Clinical Research on AIDS. Quality of life in HIV-infected individuals receiving antiretroviral therapy is related to adherence. AIDS Care. 2005 Jan;17(1):10-22. doi: 10.1080/09540120412331305098.
- Results publicationHolmes A, Lucke J, Maghidman S, Fernandez-Bussy S, Barnett B, Arduino R. Tenofovir associated nephrotoxicity is dose-dependent ritonavir administration a co-factor? XVI International AIDS Conference. Toronto, Canada. August 13-18, 2006. Abstract TUPE0085.
- Results publicationBell TK, Holmes A, McCormack OE, Barnett BJ, Arduino RC. Changing Genotypic Resistance Patterns and Demographics of Antiretroviral-Naïve HIV Patients in Houston: 1999-2006. 44th Annual Meeting of the Infectious Diseases Society of America (IDSA). Toronto, Canada. October 12-15, 2006. Abstract 975.
- Results publicationHolmes A, Bell T, Barnett B, Arduino R. Emerging resistance mutations in once-daily ritonavir-boosted protease inhibitor-containing antiretroviral regimens. 44th Annual Meeting of the Infectious Diseases Society of America (IDSA). Toronto, Canada. October 12-15, 2006. Abstract 973.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto C Arduino, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ritonavir-boosted atazanavir and ritonavir-boosted fosamprenavir in people with HIV Infections, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patient With Viral Load Less Than 400 Copies/mL (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00242216, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2014.