Pilot Study of Raltegravir Lipodystrophy IISP
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Southern California Institute for Research and Education.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Southern California Institute for Research and Education
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT01164605
First received: July 14, 2010
Last updated: May 16, 2012
Last verified: May 2012
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Purpose
The substitution of raltegravir for the NRTIs will result in some reversal of the long term adverse effect of lipodystrophy (specifically peripheral lipoatrophy) that is associated with the chronic use of NRTIs. Changing the HAART regimen in patients with a sustained virological response from a PI plus NRTI to a regimen of the PI plus raltegravir will likely result in continued virologic efficacy.
| Condition | Intervention |
|---|---|
|
HIV Infection |
Drug: Raltegravir |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study on the Efficacy of a Two Drug, Raltegravir-based Regimen,(NRTI) Sparing Antiretroviral Treatment |
Resource links provided by NLM:
Further study details as provided by Southern California Institute for Research and Education:
Primary Outcome Measures:
- Determine if the substitution of raltegravir for 2 NRTI's in patients with evidence of peripheral lipoatrophy and who have sustained HIV virological suppression will result in evidence of an increased in volume of peripheral fat within one year. [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Determining whether the patients will continue to have sustained virological suppression upon switching to a raltegravir-based regimen. [ Time Frame: eighteen months ] [ Designated as safety issue: No ]
- Determining what, if any, adverse effects the patients may develop.. [ Time Frame: eighteen months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Raltegravir
60 tablets (30-day supply)
A prospective, non-controlled, non-randomized, single center study of a treatment regimen of a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor in combination with raltegravir in patients with HIV-1 infection who have been, and continue to be, fully controlled on a standard HAART regimen of a PI or an NNRTI plus 2 NRTIs, and the effect of the change in regimen on peripheral fat distribution.
This pilot study will contain 30 patients who will be followed over a period of one year starting from the date of the medication change from an NRTI-based regimen to a raltegravir-based NRTI-sparing regimen. Potential changes in fat distribution (fat content as assessed by fat volume) will be measured with serial MRI's of the thighs.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- HIV-1 positive
- Any patient on a boosted PI plus 2 NRTIs.
- Visual evidence peripheral fat wasting
- HIV-1 viral load fully suppressed at least 9mths.
Exclusion Criteria:
- Historical resistance to PI patient receiving
- No prior exposure to raltegravir, elvitegravir, other HIV-1 integrase inhibitor.
- No contraindications to serial MRI scanning.
- No contraindications to utilization of raltegravir.
- Not currently receiving any medications drug-drug interaction w/ raltegravir.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164605
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164605
Contacts
| Contact: Stephen M Berman, M.D.,Ph.D. | (562) 826-8000 ext 2841 | stephen.berman2@va.gov | |
| Contact: Judy A Gerken, NP | (562) 826-8000 ext 5452 | judy.gerken@va.gov |
Locations
| United States, California | |
| VA Long Beach Healthcare System | Recruiting |
| Long Beach, California, United States, 90822 | |
Sponsors and Collaborators
Southern California Institute for Research and Education
Merck Sharp & Dohme Corp.
Investigators
| Principal Investigator: | Stephen M Berman, M.D., Ph.D. | Southern California Institute for Research and Education |
More Information
Additional Information:
Publications:
Efficacy, safety and tolerability of dual therapy with raltegravir and atazanavir in antiretroviral experienced patients. D. Ripamonti, F. Maggiolo, E. Bombana, et al. Presented at the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, July 19-22, 2010, Cape Town, South Africa.
Raltegravir without a protease inhibitor is highly efficacious in heavily pre-treated individuals. D. Skiest, C. Cohen, D. Barker, M. Gottlieb, et al. Presented at the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention, July 19-22, 2010, Cape Town, South Africa.
| Responsible Party: | Southern California Institute for Research and Education |
| ClinicalTrials.gov Identifier: | NCT01164605 History of Changes |
| Other Study ID Numbers: | #37977 |
| Study First Received: | July 14, 2010 |
| Last Updated: | May 16, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Southern California Institute for Research and Education:
|
NRTI-regimen Raltegravir Elvitegravir HIV-1 integrase inhibitor Fat Waste |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Raltegravir Potassium Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents HIV Integrase Inhibitors Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 30, 2016