Raltegravir Therapy for Women With HIV and Fat Accumulation
Ключови думи
Резюме
Дати
| Последна проверка: | 11/30/2012 |
| Първо изпратено: | 04/01/2008 |
| Очаквано записване подадено: | 04/03/2008 |
| Първо публикувано: | 04/09/2008 |
| Изпратена последна актуализация: | 12/16/2012 |
| Последна актуализация публикувана: | 12/18/2012 |
| Дата на първите подадени резултати: | 06/11/2012 |
| Дата на първите подадени резултати от QC: | 12/16/2012 |
| Дата на първите публикувани резултати: | 12/18/2012 |
| Действителна начална дата на проучването: | 08/31/2008 |
| Приблизителна дата на първично завършване: | 11/30/2011 |
| Очаквана дата на завършване на проучването: | 11/30/2011 |
Състояние или заболяване
Интервенция / лечение
Drug: raltegravir
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Active Comparator: Immediate Immediate switch of PI or NNRTI to Raltegravir | |
| Active Comparator: Delayed Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
1. Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2) [Baseline and 24 weeks]
