Phase 3
N=20
Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy
HIV · Hyperlipidemia · Hypertriglyceridemia · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00887653 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Oct 2014
Primary outcome: Primary: Change From Baseline Triglycerides — 125 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- raltegravir (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Miriam Hospital
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Triglycerides |
120 | — |
| PRIMARY Change From Baseline Triglycerides |
120 | — |
| SECONDARY Proportion of Patients With Plasma Viral Load Below the Limit of Detection |
— | — |
Summary
The success of combination antiretroviral therapy heralded a revolution in the treatment of HIV in the mid-1990s. However, severe treatment-associated side effects have been observed including diabetes and increased cholesterol which are linked to premature heart attacks. This effect has been described among many regimens containing protease inhibitors (PIs), as well as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Raltegravir is a new medicine which has been shown to be potent and efficacious in suppression of the HIV. This study hopes to determine if switching from a PI or NNRTI to raltegravir will decrease cholesterol in subjects with high cholesterol and well controlled HIV. In addition, the study aims to confirm that raltegravir is safe and well tolerated. It also seeks to confirm if raltegravir will have similar anti-HIV activity compared with the patient's previous regimen.
The study will last 6 months and will involve 20 subjects. HIV-1 infected men and women on PIs or NNRTIs for at least 12 months before study entry with well controlled HIV will be recruited.
Hypotheses:
1. Patients with elevated lipid levels while on combination antiretroviral therapy with PIs or NNRTIs will experience an improvement in lipid levels after switching their PI or NNRTI to a raltegravir based regimen.
2. Raltegravir will be safe and well tolerated.
3. Raltegravir will have similar antiretroviral activity compared with the prior regimen.
Primary Objective:
To demonstrate an improvement in lipid profile (triglycerides or LDL) in subjects switched to raltegravir from PIs or NNRTIs at 2, 3, and 6 months after study entry.
Study Design: Subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily. Those who consent, will receive raltegravir provided by the study for 6 months. At entry, the subjects will undergo a complete physical exam and thereafter targeted exams at each visit. Labs will be drawn as part of clinical care at 2, 3, and 6 months. Some of the blood will be stored for later analysis. Also, the subjects will answer regular surveys on drug toxicity and quality of life. Their cholesterol level will be compared before and after the study. At the end of the study, the participants may choose to continue on raltegravir if they desire.
Eligibility Criteria
Inclusion Criteria
- Age >18
- Fasting LDL>130 mg/dL
- Fasting triglycerides >250 mg/dL
- Plasma viral load below 50 copies/mL on current regimen for 6 months prior to study entry.
- No prior history of any NRTI resistance.
Exclusion Criteria
- History of NRTI resistance mutations
- Need for medications that have drug interactions with raltegravir: dilantin, phenobarbitol and rifampin
- Unstable clinical condition, such as unstable cardiac disease, or cancer requiring ongoing chemotherapy or radiation therapy, or other medical condition which, in the opinion of the investigator, would preclude a subject from safely undergoing study procedures.
- Breast-feeding or pregnancy.
- Use of immunosuppressive medications within 60 days prior to study entry.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Data sourced from ClinicalTrials.gov (NCT00887653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.