Raltegravir Therapy for Women With HIV and Fat Accumulation
Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Lipodystrophy
Intervention: raltegravir (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of California, Los Angeles Official(s) and/or principal investigator(s): Judith S. Currier, M.D., Principal Investigator, Affiliation: University of California, Los Angeles Grace McComsey, M.D., Study Chair, Affiliation: Case School of Medicine
Summary
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).
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
- 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
Locations and Contacts
UCLA CARE Center, Los Angeles, California 90035, United States
Tufts University School of Medicine, Boston, Massachusetts 02111, United States
Case School of Medicine, Cleveland, Ohio 44106, United States
University Health Network, Toronto, Toronto, Ontario, Canada
Vanderbilt University, Nashville, Tennessee 37203, United States
Additional Information
Starting date: September 2008
Last updated: December 17, 2012
|