HIV Infections
Conditions
Keywords
HIV infection, Raltegravir, Switch, Hyperlipidemia, Women
Brief summary
This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily. This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV infected women from a PI based regimen to raltegravir.
Interventions
DRUGRaltegravir
Sponsors
Merck Sharp & Dohme LLC
Arbeitsgemeinschaft medikamentoese Tumortherapie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Documented HIV-1 infection in female patients, age ≥18 years * Patients receiving antiretroviral therapy consisting of at least 2 antiretroviral agents other than protease inhibitor plus a ritonavir-boosted protease inhibitor (PI) for at least the previous 6 months * Plasma HIV viral load \<50 copies/ml on current boosted PI containing regimen for ≥ 6 months prior to study entry * Fasting LDL cholesterol \>130 mg/dl * Fasting triglycerides \<450 mg/dl
Exclusion criteria
* History of virological failure during previous antiretroviral therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction | baseline to week 12 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Total Cholesterol Baseline and After 24 Weeks | baseline to week 24 |
| Triglycerides Baseline and After 24 Weeks | baseline to week 24 |
| High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks | baseline to week 24 |
Countries
Austria
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Raltegravir 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 | 11 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | patient was abroad for 6 months | 1 |
Baseline characteristics
| Characteristic | Raltegravir |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 11 |
| serious Total, serious adverse events | 1 / 11 |
Outcome results
Primary
Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction
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
Population: all patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Raltegravir | Patients With Low-density Lipoprotein (LDL) Cholesterol Reduction | 90.9 percentage of participants |
Secondary
High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks
Time frame: baseline to week 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Raltegravir | High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks | Baseline | 58 mg/dl | Standard Deviation 14.09 |
| Raltegravir | High-density Lipoprotein (HDL) Cholesterol Baseline and After 24 Weeks | 24 weeks | 64 mg/dl | Standard Deviation 12.75 |
Secondary
Total Cholesterol Baseline and After 24 Weeks
Time frame: baseline to week 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Raltegravir | Total Cholesterol Baseline and After 24 Weeks | Baseline | 247.55 mg/dl | Standard Deviation 21.07 |
| Raltegravir | Total Cholesterol Baseline and After 24 Weeks | 24 weeks | 215.7 mg/dl | Standard Deviation 28.55 |
Secondary
Triglycerides Baseline and After 24 Weeks
Time frame: baseline to week 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Raltegravir | Triglycerides Baseline and After 24 Weeks | Baseline | 168.45 mg/dl | Standard Deviation 57.08 |
| Raltegravir | Triglycerides Baseline and After 24 Weeks | 24 weeks | 83.3 mg/dl | Standard Deviation 28.94 |