Raltegravir Therapy for Women With HIV and Fat Accumulation
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| ClinicalTrials.gov Identifier: NCT00656175 |
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Recruitment Status :
Completed
First Posted : April 10, 2008
Results First Posted : December 19, 2012
Last Update Posted : December 19, 2012
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Ritonavir-boosted protease inhibitor (PI) regimens have become a backbone for treatment of people with HIV. However, adverse drug effects, particularly lipodystrophy/lipoatrophy are closely associated with these regimens. Therefore, there is a need for a drug with comparable effectiveness to the ritonavir boosted PIs without the side effects of dyslipidemia, which has been associated with elevated cholesterol and cardiovascular disease
Raltegravir is an HIV integrase inhibitor in phase III clinical development. To date there are no approved drugs that target the same stage of the HIV-1 lifecycle. However, data from studies indicate that raltegravir is generally safe and well tolerated and has strong antiretroviral activity when used in combination with licensed antiretroviral medications.
This study aims to demonstrate that patients substituting raltegravir for a PI or NNRTI based antiretroviral regimen will be associated with a 10% reduction in body fat over 24 weeks.
The study will consist of a total of 10 subject visits over a period of 48 weeks. Approximately 40 female patients will participate in this study (approximately 10 at UCLA).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections Lipodystrophy | Drug: raltegravir | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 39 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Raltegravir as Replacement for Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Based Antiretroviral Therapy in Women With Fat Accumulation |
| Study Start Date : | September 2008 |
| Actual Primary Completion Date : | December 2011 |
| Actual Study Completion Date : | December 2011 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Immediate
Immediate switch of PI or NNRTI to Raltegravir
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Drug: raltegravir
raltegravir
Other Name: Isentress |
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Active Comparator: Delayed
Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir
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Drug: raltegravir
raltegravir
Other Name: Isentress |
- Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2) [ Time Frame: Baseline and 24 weeks ]Adipose tissue volumes were measured via single slice L4-L5 CT scan, and volumes were calculated using cm^2, not cm^3, as is standard protocol at the Tufts University Body Composition Reading Center. The authors acknowledge that cm^2 uses area as a surrogate for volume, but this protocol is well-accepted in our field.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry or plasma HIV-1 RNA > 2000 on two occasions,
- Female subjects 18 years or older
- Documented central fat accumulation (defined by waist circumference of > 94 cm or a waist to hip ratio of > 0.88).
- Documented HIV RNA <50 copies/mL at screening and <400 copies/mL in the past 6 months.
- Current antiretroviral therapy with two nucleoside analogues and either a non-nucleoside analogue (nevirapine, efavirenz or TMC125) or an approved protease inhibitor. Patients on NNRTI+PI at study entry will be excluded. Study participants do not need to be on their first regimen. No changes in ART in the 12 weeks prior to screening. The nucleoside backbone must include either tenofovir or abacavir and either lamivudine or emtricitabine. Fixed dose combinations with emtricitabine or abacavir are allowed.
- For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy and/or tubal ligation), will need a negative serum or urine pregnancy test within 48 hours prior to entry.
- Ability and willingness of subject to provide informed consent.
Exclusion Criteria:
- Pregnancy: current or within the past 6 months or breast feeding
- Prior treatment history that would preclude the use of emtricitabine or abacavir as the nucleoside backbone during study treatment
- Current use of metformin or thiazolidinediones.
- Use of growth hormone or growth hormone releasing factor in the last 6 months before screening.
- Change or initiation of anti-hyperlipemic regimen within 3 months prior to randomization; Use of stable anti-hyperlipemic regimen during the study is allowed.
- Current use of androgen therapy.
- Intent to modify diet, exercise habits or to enroll in a weight loss intervention during the study period.
- Current or projected need to use rifampin, dilantin or phenobarbital during the 48-week study period.
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Laboratory values at screening of
- ANC >500 cells/mm3
- Hemoglobin <10 gm/dl
- CrCl > 60 ml/min (estimated by Cockcroft-Gault equation)
- AST or ALT > 3 x ULN
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656175
| United States, California | |
| UCLA CARE Center | |
| Los Angeles, California, United States, 90035 | |
| United States, Massachusetts | |
| Tufts University School of Medicine | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Ohio | |
| Case School of Medicine | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37203 | |
| Canada, Ontario | |
| University Health Network, Toronto | |
| Toronto, Ontario, Canada | |
| Principal Investigator: | Judith S. Currier, M.D. | University of California, Los Angeles | |
| Study Chair: | Grace McComsey, M.D. | Case School of Medicine |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Judith S. Currier, M.D., University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00656175 |
| Obsolete Identifiers: | NCT00755612 |
| Other Study ID Numbers: |
IISP-Raltegravir |
| First Posted: | April 10, 2008 Key Record Dates |
| Results First Posted: | December 19, 2012 |
| Last Update Posted: | December 19, 2012 |
| Last Verified: | December 2012 |
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lipodystrophy fat visceral fat HIV women raltegravir |
ART anti HIV therapy NNRTI Protease inhibitor integrase inhibitor treatment experienced |
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Lipodystrophy Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic 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 |