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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
Sponsor:
Information provided by (Responsible Party):
Roberto Arduino, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Drug: ritonavir-boosted atazanavir
Drug: ritonavir-boosted fosamprenavir
Enrollment 76
Recruitment Details Patients enrolled at a county clinic
Pre-assignment Details  
Arm/Group Title Atazanavir Fosamprenavir
Hide Arm/Group Description Atazanavir/ritonavir (300mg/100mg) once daily Fosamprenavir/ritonavir (1400mg/100mg) once daily
Period Title: Overall Study
Started 39 37
Completed 21 15
Not Completed 18 22
Reason Not Completed
Lost to Follow-up             12             17
Death             4             2
Lack of Efficacy             1             2
no medicaiton dispensed             1             1
Arm/Group Title Atazanavir Fosamprenavir Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 39 37 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 37 participants 76 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  97.4%
33
  89.2%
71
  93.4%
>=65 years
1
   2.6%
4
  10.8%
5
   6.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 37 participants 76 participants
48  (9.7) 48  (10) 48  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 37 participants 76 participants
Female
11
  28.2%
9
  24.3%
20
  26.3%
Male
28
  71.8%
28
  75.7%
56
  73.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants 37 participants 76 participants
39 37 76
1.Primary Outcome
Title Proportion of Patient With Viral Load Less Than 400 Copies/mL
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atazanavir Fosamprenavir
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 18 15
Measure Type: Number
Unit of Measure: percentage
89 73
2.Secondary Outcome
Title CD4 Cell Count Change From Baseline During Treatment.
Hide Description [Not Specified]
Time Frame 24 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Atazanavir Fosamprenavir
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 18 15
Mean (Standard Deviation)
Unit of Measure: cell/mm3
139  (119) 117  (99)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atazanavir Fosamprenavir
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Atazanavir Fosamprenavir
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atazanavir Fosamprenavir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/39 (23.08%)      6/37 (16.22%)    
Blood and lymphatic system disorders     
Anemia   0/39 (0.00%)  0 1/37 (2.70%)  2
Gastrointestinal disorders     
Left perineal abscess   1/39 (2.56%)  1 0/0  0
Abdominal Pain   1/39 (2.56%)  1 0/37 (0.00%)  0
General disorders     
death   3/39 (7.69%)  3 2/37 (5.41%)  2
Infections and infestations     
Cryptococal meningitis   0/39 (0.00%)  0 1/37 (2.70%)  1
Nervous system disorders     
Seizure Disorder   1/39 (2.56%)  5 0/37 (0.00%)  0
Intracraneal Hypertension   1/39 (2.56%)  1 0/37 (0.00%)  0
Reproductive system and breast disorders     
Rupture hemorrhagic cyst   0/39 (0.00%)  0 1/37 (2.70%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonia   1/39 (2.56%)  1 1/37 (2.70%)  1
Skin and subcutaneous tissue disorders     
Steven's Johnson Syndrome   1/39 (2.56%)  1 0/37 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Atazanavir Fosamprenavir
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/39 (23.08%)      0/37 (0.00%)    
Gastrointestinal disorders     
hyperbilirrubinemia  7/39 (17.95%)  7 0/37 (0.00%)  0
Hepatobiliary disorders     
Increased LFTs   2/39 (5.13%)  2 0/37 (0.00%)  0
Indicates events were collected by systematic assessment
High porportion of subject did not complete the study.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Roberto C. Arduino, Professor of Medicine
Organization: The University of Texas Health Science Center at Houston
Phone: 713-500-6731
EMail: roberto.c.arduino@uth.tmc.edu
Publications of Results:
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.
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.
Other Publications:
Layout table for additonal information
Responsible Party: Roberto Arduino, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00242216     History of Changes
Other Study ID Numbers: HSC-MS-03-315
First Submitted: October 18, 2005
First Posted: October 19, 2005
Results First Submitted: May 2, 2013
Results First Posted: October 17, 2013
Last Update Posted: January 15, 2014