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ObjectivesCurrent research is unclear about the most effective pharmacological agents for managing the loss of weight and fat-free mass common in HIV/AIDS. The aim of this study was to compare nandrolone decanoate with placebo and testosterone. MethodsThe study was a multicentre randomized double-blind placebo-controlled trial. Three hundred and three adult HIV-positive male patients with a weight loss of 5-15% in the last 12 months, or a body mass index of 17-19 kg/m 2 , or a body cell mass/height ratio lower than 13.5 kg/m, were randomly assigned to receive nandrolone decanoate (150 mg), testosterone (250 mg) or placebo intramuscularly every 2 weeks for 12 weeks. Fat-free mass, weight, immune markers and perception of treatment were the main outcome measures. ResultsTreatment with nandrolone resulted in significantly greater increases in fat-free mass [mean increase 1.34 kg; 95% confidence interval (CI) 0.60; 2.08 kg] and in weight (mean increase 1.48 kg; 95% CI 0.82; 2.14 kg) compared with placebo. The mean increase in weight with nandrolone of 1.00 kg (95% CI 0.27; 1.74 kg) when compared with testosterone was significant, although the difference in fat free mass did not reach significance (mean increase 0.69 kg; 95% CI-0.13; 1.51 kg). Patient perception of benefit was significantly greater in the nandrolone group when compared with both the placebo and the testosterone groups. ConclusionsTreatment with nandrolone decanoate increased body weight when compared with placebo and testosterone. Nandrolone decanoate treatment resulted in greater increases in fat-free mass than placebo and demonstrated a trend for a significant increase when compared with testosterone.Keywords: anabolic steroids, HIV, nandrolone decanoate, testosterone, weight loss IntroductionDespite the introduction of highly active antiretroviral therapy (HAART), weight loss continues to be prevalent in HIV disease [1,2]. More importantly, the introduction of [6]. Lowered testosterone levels have also been associated with loss of fat-free mass in HIV disease [7]. There are a number of different pharmacological agents available to assist in management of HIV-associated weight loss [8]. These agents include appetite stimulants such as corticosteroids, megestrol acetate, thalidomide and anabolic and androgenic agents (e.g. growth hormone, nandrolone decanoate and testosterone). The anabolic and androgenic agents are the only ones to have shown consistent improvements in both weight and fat-free mass [9][10][11][12].Currently, in the clinical management of weight loss in HIV-infected patients, there remains uncertainty about the best approach. After investigation of any underlying cause of weight loss, such as inadequate dietary intake, diarrhoea, opportunistic infections or malignancy, there are no clear guidelines as to the most appropriate agent to use to assist patients to increase fat free mass.There were two primary aims of this study. First, we intended to compare the effectiveness of 12 weeks of therapy with nandrolone decanoate with placeb...

Objective: The objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP). Study design: US health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localizationor removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA. Results: Among 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization-or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal. Conclusion: Events related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant. Implications: This report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the utility and real-life experience that clinical training programs can provide.