Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV wasting

@article{Hengge2003DoubleblindRP,
  title={Double-blind, randomized, placebo-controlled phase III trial of oxymetholone for the treatment of HIV wasting},
  author={Ulrich R. Hengge and Kristin Stocks and Heidi Wiehler and Sandy Faulkner and Stefan Esser and Christine Lorenz and Walter Jentzen and Dagmar Hengge and Manfred Goos and Robert E. Dudley and Gary L. Ringham},
  journal={AIDS},
  year={2003},
  volume={17},
  pages={699-710}
}
Background: Despite highly active antiretroviral therapy (HAART), chronic involuntary weight loss still remains a serious problem in the care of HIV patients. Various alterations in energy metabolism and endocrine regulation have been found to cause loss of lean body mass (LBM) and body cell mass (BCM). Previous studies in HIV-positive men undergoing androgen replacement therapy or treatment with recombinant growth hormone (rGH) have shown partial restoration of LBM, but these treatments have… Expand
Effect of nandrolone decanoate therapy on weight and lean body mass in HIV-infected women with weight loss: a randomized, double-blind, placebo-controlled, multicenter trial.
TLDR
Nandrolone decanoate therapy may prove to be generally safe and beneficial in reversing weight loss and lean tissue loss in women with HIV infection and other chronic catabolic diseases. Expand
Oxandrolone in the Treatment of HIV-Associated Weight Loss in Men: A Randomized, Double-Blind, Placebo-Controlled Study
TLDR
Oxandrolone administration is effective in promoting dose-dependent gains in body weight and BCM in HIV-infected men with weight loss and was associated with significant suppression of sex hormone-binding globulin, luteinizing hormone, follicle-stimulating hormone, and total and free testosterone levels. Expand
Testosterone supplementation of megestrol therapy does not enhance lean tissue accrual in men with human immunodeficiency virus-associated weight loss: a randomized, double-blind, placebo-controlled, multicenter trial.
TLDR
Whether coadministration of testosterone with MA could enhance lean body mass (LBM) accrual and evaluate the effects of MA, alone or combined with testosterone, on sexual functioning and the hypothalamic-pituitary-adrenal axis is evaluated. Expand
Effects of Testosterone Supplementation on Body Composition in HIV Patients: A Meta-analysis of Double-blinded Randomized Controlled Trials
This study was designed to evaluate the effects of testosterone supplementation (TS) on body composition in patients with HIV and the side effects of TS. A comprehensive literature search strategyExpand
Anabolic steroids for the treatment of weight loss in HIV-infected individuals.
TLDR
The results suggest that anabolic steroids may be useful in the treatment of weight loss in HIV infected individuals, but due to limitations, treatment recommendations cannot be made. Expand
Efficacy of Selected Treatments of HIV Wasting: A Systematic Review and Meta-Analysis
TLDR
Although meta-analysis did not indicate any statistically significant differences between these agents in the degree of efficacy in this outcome, the Food and Drug Administration–approved dose of rhGH may have advantages over the other 2 therapies in terms of improvements in functional capacity and QoL. Expand
Mammalian Cell-Derived Somatropin
TLDR
Somatropin 0.1 mg/kg/day administered subcutaneously for 12 weeks effectively increased work output, bodyweight and lean body mass and improved health-related quality of life (HR-QOL), compared with placebo, and had a generally manageable tolerability profile in a large randomised study in patients with HIV-associated wasting. Expand
Clinical utility of dronabinol in the treatment of weight loss associated with HIV and AIDS
TLDR
An in-depth evaluation based on existing clinical trials on the clinical utility of dronabinol in the treatment of weight loss associated with HIV/AIDS finds it to be a well-tolerated option to promote appetite stimulation. Expand
Treatment with nandrolone decanoate and megestrol acetate in HIV-infected men.
TLDR
The combined treatment with megestrol acetate and nandrolone decanoate led to a significant increase in body weight and FFM and Muscle strength and quality of life improved during the study. Expand
Highly Active Antiretroviral Therapy-Associated Metabolic Syndrome and Lipodystrophy: Pathophysiology and Current Therapeutic Interventions
TLDR
This review focuses on the proposed mechanisms involved in the development of metabolic syndrome and lipodystrophy, and highlights suggested potential therapeutic interventions to prevent lipody Strophy associated with HAART. Expand
...
1
2
3
4
5
...

References

SHOWING 1-10 OF 63 REFERENCES
Recombinant human growth hormone in patients with HIV-associated wasting. A randomized, placebo-controlled trial. Serostim Study Group.
TLDR
Treatment with growth hormone increases body weight, lean body mass, and treadmill work output and appears to be a safe and potentially effective therapy in patients with HIV-associated wasting. Expand
Oxymetholone promotes weight gain in patients with advanced human immunodeficiency virus (HIV-1) infection.
TLDR
Oxymetholone was safe and promoted weight gain in cachectic patients with advanced HIV-1 infection and the need for a randomized, double-blind, placebo-controlled multicentre trial is suggested. Expand
Resistance exercise and supraphysiologic androgen therapy in eugonadal men with HIV-related weight loss: a randomized controlled trial.
TLDR
A moderately supraphysiologic androgen regimen that included an anabolic steroid, oxandrolone, substantially increased the lean tissue accrual and strength gains from PRE, compared with physiologic testosterone replacement alone, in eugonadal men with HIV-associated weight loss. Expand
Monitoring changes in fat-free mass in HIV-positive men with hypotestosteronemia and AIDS wasting syndrome treated with gonadal hormone replacement therapy.
TLDR
The BIS method is less costly, more convenient to use, and had results that more closely matched those from nitrogen balance and retention methods, which may be the preferred method to monitor changes in fat-free mass in AIDS patients and patients with malnutrition. Expand
Glutamine-antioxidant supplementation increases body cell mass in AIDS patients with weight loss: a randomized, double-blind controlled trial.
TLDR
GLN-antioxidant nutrient supplementation can increase body weight, body cell mass, and intracellular water when compared with placebo supplementation and provides a highly cost-effective therapy for the rehabilitation of HIV+ patients with weight loss. Expand
Thalidomide for the treatment of AIDS-associated wasting.
TLDR
Thalidomide therapy was associated with mild to moderate rashes and fevers, but not peripheral neuropathy, and the anabolic benefits of high-dose thalidomides are limited by drug intolerance, 8 weeks of low- doses results in significant weight gain in patients with AIDS-associated wasting. Expand
Sustained anabolic effects of long-term androgen administration in men with AIDS wasting.
TLDR
Testosterone administration results in sustained increases in LBM during 1 year of therapy in hypogonadal men with AIDS wasting, which is consistent with previous studies that have found lean body mass increases after treatment with testosterone. Expand
Transdermal testosterone administration in women with acquired immunodeficiency syndrome wasting: a pilot study.
TLDR
A novel method to augment testosterone levels in such patients that is safe and well tolerated during short term administration is demonstrated, and testosterone therapy was associated with positive trends in weight gain and quality of life. Expand
Effects of nandrolone decanoate therapy in borderline hypogonadal men with HIV-associated weight loss.
  • A. Strawford, T. Barbieri, +7 authors M. Hellerstein
  • Medicine
  • Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association
  • 1999
TLDR
Nandrolone decanoate therapy in the absence of an exercise program in borderline hypogonadal men with AWS caused substantial nitrogen retention compared with placebo, similar in extent to the nitrogen retention previously achieved with recombinant growth hormone. Expand
Safety and efficacy of nandrolone decanoate for treatment of wasting in patients with HIV infection
TLDR
Nandrolone decanoate has beneficial effects on weight, lean body mass and quality of life in selected patients who have mild to moderate HIV wasting. Expand
...
1
2
3
4
5
...