Abstract
Highly active antiretroviral therapy (HAART) was recently associated with disturbance of lipid metabolism, fat mass distribution and insulin resistance, known to be partly regulated by steroid hormones. Nevertheless, complementary or adjunctive wide used of dehydroepiandrosterone (DHEA) in fully suppressed HIV patients appeared to have no beneficial antiviral, immuno modulatory, hormonal or body composition effects. Herein, we tested in vivo safety and efficacy of IM28, a potent analog of DHEA, on volunteers HIV positive patients from Gabon, randomly organized as followed: IM28 alone (15 patients + 30 healthy individuals), IM28+HAART (150 patients), HAART alone (13 patients) and DHEA+HAART (23 patients). All patients were evaluated three times: M0 (pre-treatment with IM28), M1 (after six months of treatment with IM28) and M2 (after 12 months of treatment with IM28). No noticeable side effects were observed for IM28 as evaluated by measuring hepatic, cardiac, renal functions and body weight progression. Compared to HAART therapy, combinations DHEA+HAART, IM28+HAART or IM28, quickly rescued patients from anxiety, restored their appetite and normalized their body weight. However, only patients receiving IM28 alone or in combination with HAART showed normalization of body temperatures and increase in the levels of CD4 lymphocytes (p<0.01) and haemoglobin (p<0.001), as well as significant reductions of platelets antigenemia p24 (p<0.001) and viral load (p<0.01). Moreover, only cardiovascular, obese and hypertensive disease-induced HAART therapy patients under IM28 showed restoration of body levels in lipids, glucose and normalization of blood pressure. These data unequivocally suggest therapeutic proprieties to IM28 for HIV-1 and cardiovascular-induced HAART therapy. These open new promising insights for IM28.
Highlights
Despite remarkable improvements of the survival and quality of life style in HIV patients with the use of highly active antiretroviral therapy (HAART), cross-sectional and prospective studies have reported chronically complications including hyperlipidemia, lipodystrophy and impaired glucose metabolism, qualified as metabolic syndrome
We tested the safety of IM28 on 30 healthy volunteers and 15 naïve patients freshly diagnose with HIV1
Data from the baseline (M0) for hepatic, cardiac and renal functions measured to M2 on healthy volunteers or 15 patients under IM28 alone did not shown dramatics variations from the baselines values for urea (3.73 ± 0.12 vs 4.70 ± 0.25 mmol), TGP (10.50 ± 0.98 vs 11.70±1.03 UI/I), Cholesterol (4.15 ± 0.98 vs4.09 ± 0.12) albeit significant increases seen for creatinine (77.50 ± 2.50 vs 105.20 ± 6.04 mmol), oxaloacetic transaminase (GOT) (12.10 ± 0.60 vs 15.90 ± 1.11UI/ I), which remained in the range of normal values
Summary
Despite remarkable improvements of the survival and quality of life style in HIV patients with the use of highly active antiretroviral therapy (HAART), cross-sectional and prospective studies have reported chronically complications including hyperlipidemia, lipodystrophy and impaired glucose metabolism, qualified as metabolic syndrome. The later result in cardiovascular disorders such as diabetes, hypertension, abdominal obesity, l ow HDL, hyperch olesterolem ia, Received December 03, 2009; Accepted December 26, 2009; Published December 26, 2009. Volume 1(2): 076-081 (2009) - 076 ISSN:1948-5964 JAA, an open access journal DHEA still limited as no helpful antiviral, hormonal, or body composition has been noticed in fully suppressed HIV patients (Abrams et al, 2007)
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