Raltegravir Therapy for Women With HIV and Fat Accumulation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00656175
• Date of registration: 02/04/2008
• Prospective Registration: Yes
• Primary sponsor: University of California, Los Angeles
• Public title: Raltegravir Therapy for Women With HIV and Fat Accumulation
• Scientific 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
• Date of first enrolment: September 2008
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00656175
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Canada, United States

Contacts

• Name: Judith S. Currier, M.D.
• Affiliation: University of California, Los Angeles

• Name: Grace McComsey, M.D.
• Affiliation: Case School of Medicine

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Lipodystrophy

HIV Infections

Intervention(s)

Drug: raltegravir

Primary Outcome(s)

Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2) [Time Frame: Baseline and 24 weeks]

Secondary ID(s)

IISP-Raltegravir

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Tufts University

University Health Network, Toronto

Merck Sharp & Dohme Corp.

Vanderbilt University

Case Western Reserve University

Results

• Results available: Yes
• Date Posted: 19/12/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00656175