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Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02097108
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Arbeitsgemeinschaft medikamentoese Tumortherapie

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV Infections
Intervention Drug: Raltegravir
Enrollment 11
Recruitment Details 11 patients were enrolled at 3 sites in Austria. First patient in was 15.05.2014; last patient in was 23.06.2015.
Pre-assignment Details  
Arm/Group Title Raltegravir
Hide Arm/Group Description

Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.

Raltegravir

Period Title: Overall Study
Started 11
Completed 9
Not Completed 2
Reason Not Completed
Adverse Event             1
patient was abroad for 6 months             1
Arm/Group Title Raltegravir
Hide Arm/Group Description

Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.

Raltegravir

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
11
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction
Hide Description A reduction of > 5% in the plasma concentration of direct LDL cholesterol from baseline to week 12 or > 10% reduction of total cholesterol or reduction of lipid lowering agents is expected. Reduction of lipid lowering agents is defined as reduction due to amelioration of lipid profiles and does not include reduction due to side effects or other toxicity issues.
Time Frame baseline to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
all patients
Arm/Group Title Raltegravir
Hide Arm/Group Description:

Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.

Raltegravir

Overall Number of Participants Analyzed 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90.9
(58.7 to 99.8)
2.Secondary Outcome
Title Total Cholesterol Baseline and After 24 Weeks
Hide Description [Not Specified]
Time Frame baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir
Hide Arm/Group Description:

Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.

Raltegravir

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mg/dl
Baseline 247.55  (21.07)
24 weeks 215.7  (28.55)
3.Secondary Outcome
Title Triglycerides Baseline and After 24 Weeks
Hide Description [Not Specified]
Time Frame baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir
Hide Arm/Group Description:

Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.

Raltegravir

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mg/dl
Baseline 168.45  (57.08)
24 weeks 83.3  (28.94)
4.Secondary Outcome
Title High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks
Hide Description [Not Specified]
Time Frame baseline to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir
Hide Arm/Group Description:

Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.

Raltegravir

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mg/dl
Baseline 58  (14.09)
24 weeks 64  (12.75)
Time Frame 19 months
Adverse Event Reporting Description All (serious) adverse events occuring during study treatment were collected until 28 days after the end of study treatment.
 
Arm/Group Title Raltegravir
Hide Arm/Group Description

Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.

Raltegravir

All-Cause Mortality
Raltegravir
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Raltegravir
Affected / at Risk (%) # Events
Total   1/11 (9.09%)    
Gastrointestinal disorders   
Abdominal pain  1  1/11 (9.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Raltegravir
Affected / at Risk (%) # Events
Total   5/11 (45.45%)    
Gastrointestinal disorders   
Abdominal pain  1  1/11 (9.09%)  1
Constipation  1  1/11 (9.09%)  1
General disorders   
Pyrexia  1  1/11 (9.09%)  1
Investigations   
Aspartate aminotransferase increased  1  1/11 (9.09%)  1
Alanine aminotransferase increased  1  1/11 (9.09%)  1
Gamma-glutamyltransferase increased  1  1/11 (9.09%)  1
Nervous system disorders   
Headache  1  1/11 (9.09%)  1
Renal and urinary disorders   
Dysuria  1  1/11 (9.09%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/11 (9.09%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  1/11 (9.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Public contact Daniela Wolkersdorfer
Organization: AGMT
Phone: 00436626404411
EMail: d.wolkersdorfer@agmt.at
Layout table for additonal information
Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT02097108    
Other Study ID Numbers: AGMT_HIV1
First Submitted: March 24, 2014
First Posted: March 26, 2014
Results First Submitted: June 15, 2016
Results First Posted: September 13, 2016
Last Update Posted: September 13, 2016