icon_folder.gif   Conference Reports for NATAP  
 
  7th International Workshop on
Adverse Drug Reactions and Lipodystrophy in HIV
November 13-17, 2005
Dublin, Ireland
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Testosterone gel switch strategy: perceptions of non-response specific to sexual function/satisfaction and dose titration issues of HIV-positive men
 
 
  Abstracts presented at the 7th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 13-16 November 2005, Dublin, Ireland
 
S Schrader 1, A Mills 2, M Scheperle3 and JE Block4 1The Schrader Clinic, Houston, TX, USA; 2Private Practice Los Angeles, CA, USA; 3Private Practice, St. Louis, MO, USA; 4Private Consultant, San Francisco, CA, USA
 
ABSTRACT 96
Antiviral Therapy 2005; 10:L57
 
Objectives: Evaluate the clinical effectiveness of switching to Testim 1% testosterone gel therapy in HIV+ males who failed to respond in respect to sexual functioning and libido following a prior treatment period of AndroGel 1% testosterone gel therapy. Provide a proof of concept to qualify needs for research in HIV-positive, testosterone gel non-responders.
 
Methods: Open label, multicentre study (n=48, two arms of 24): consecutive subjects were assigned randomly to experimental treatment, Testim 1% (5 g) once daily (n=24), or to continued maintenance of control therapy, AndroGel 1% (5 g) once daily (n=24). At baseline and after 4 weeks, all subjects completed the Brief Male Sexual Function Inventory (BMSFI) survey of five separate domains: sexual drive, erectile function, ejaculatory function, problem assessment and sexual satisfaction; all changes from baseline were compared (Wilcoxon Rank Sum Test). At 4 weeks, investigators assessed all subjects and determined the need for upward medication titration based on persistent symptoms. Subjects were required to have documentation of PSA=4 ng/ml <45 days prior to initiation of study medication.
 
Results: The average length of follow-up was 28.3 ±7.6 days and 31.8 ±2.0 days for experimental and control subjects, respectively.
 
The average % improvement from baseline to 4 weeks favoured the experimental treatment in all five domains of the BMSFI survey including sexual drive (53% vs 18%, P=0.0005), erectile function (49% vs 7%, P=0.0035), ejaculatory function (15% vs 8%, P=0.138), problem assessment (59% vs 12%, P=0.0025) and sexual satisfaction (58% vs 9%, P=0.0058).
 
A greater percentage of subjects also reported satisfaction with the experimental treatment (85% vs 48%, P=0.026) and these subjects were less likely to require upward dose titration at the final follow-up visit (30% vs 74%, P=0.01).
 
Conclusions: Proof of concept was achieved: Although the limitations of this study precluded the investigators from reliably determining if Testim 1% gel therapy should be considered in HIV+ males who inadequately responded (re: sexual functioning/libido) to prior AndroGel therapy, the ‘real life’ clinical model of this trial revealed clinical issues that require further, rigorous, scientific investigation to improve the effectiveness of testosterone replacement therapy in HIV+ hypogonadal men.