"The Once A Day Protease Inhibitor Regimens"

NCT00242216 | Completed Phase 4 Results

• 1 other identifier: HSC-MS-03-315
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

HIV Infections

Keywords

HIV-1 infected people; Antiretroviral treatment-naïve; Atazanavir; Fosamprenavir; ARV Treatment Naive

Outcome Measures

Primary Outcomes (1)

• Proportion of Patient With Viral Load Less Than 400 Copies/mL

  24 weeks

Secondary Outcomes (1)

• CD4 Cell Count Change From Baseline During Treatment.

  24 weeks.

Study Arms (2)

Atazanavir oral once daily

ACTIVE COMPARATOR

HIV treatment

Drug: ritonavir-boosted atazanavir

Fosamprenavir oral once daily

ACTIVE COMPARATOR

HIV treatment

Drug: ritonavir-boosted fosamprenavir

Interventions

ritonavir-boosted atazanavir DRUG

100 mg ritonavir plus 300 mg atazanavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.

Also known as: Reyataz plus Norvir

Atazanavir oral once daily

ritonavir-boosted fosamprenavir DRUG

100 mg ritonavir plus 1,400 mg fosamprenavir in combination with tenofovir-emtricitabine fixed dose combination given once daily.

Also known as: Lexiva plus Norvir

Fosamprenavir oral once daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Thomas Street Health Center

Houston, Texas, 77009, United States

Location

Related Publications (12)

• 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.

  PMID: 14685054 BACKGROUND

• Sax 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.

  PMID: 14666914 BACKGROUND

• Bayes M, Rabasseda X, Prous JR. Gateways to clinical trials. Methods Find Exp Clin Pharmacol. 2003 Jul-Aug;25(6):483-506.

  PMID: 12949633 BACKGROUND

• Goldsmith DR, Perry CM. Atazanavir. Drugs. 2003;63(16):1679-93; discussion 1694-5. doi: 10.2165/00003495-200363160-00003.

  PMID: 12904086 BACKGROUND

• Rodriguez-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.

  PMID: 14707788 BACKGROUND

• SOLO trial results released. AIDS Patient Care STDS. 2003 Feb;17(2):95. doi: 10.1089/108729103321150827. No abstract available.

  PMID: 12639292 BACKGROUND

• Falcoz 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.

  PMID: 12162471 BACKGROUND

• Vierling P, Greiner J. Prodrugs of HIV protease inhibitors. Curr Pharm Des. 2003;9(22):1755-70. doi: 10.2174/1381612033454441.

  PMID: 12871195 BACKGROUND

• Mannheimer 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.

  PMID: 15832830 BACKGROUND

• Holmes 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Atazanavir Sulfate; Ritonavir; fosamprenavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Limitations and Caveats

High porportion of subject did not complete the study.

Results Point of Contact

• Title: Dr. Roberto C. Arduino, Professor of Medicine
• Organization: The University of Texas Health Science Center at Houston

roberto.c.arduino@uth.tmc.edu

713-500-6731

Study Officials

• Roberto C Arduino, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Internal Medicine

Study Record Dates

• First Submitted: October 18, 2005
• First Posted: October 19, 2005
• Study Start: May 1, 2004
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 15, 2014
• Results First Posted: October 17, 2013

Record last verified: 2013-12

Locations

US (1)