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HIV Wasting Syndrome clinical trials

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NCT ID: NCT00637572 Completed - HIV Infections Clinical Trials

Evaluate Weight Gain Using 2 Different Formulations of Megestrol Acetate Oral Suspension for AIDS-related Weight Loss

Start date: December 2004
Phase: Phase 2
Study type: Interventional

Explore weight gain in HIV-positive patients who have weight loss associated with AIDS-related wasting (anorexia/cachexia). Patients are treated for 12 weeks with either megestrol acetate oral suspension nanocrystal dispersion formulation, or megestrol acetate oral suspension original formulation

NCT ID: NCT00489528 Completed - HIV Infections Clinical Trials

Growth Hormone in the Treatment of HIV-Associated Wasting

Start date: July 1997
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare physical function and lean body mass in patients getting different doses of somatropin compared to patients not getting the drug.

NCT ID: NCT00006167 Completed - Clinical trials for HIV Wasting Syndrome

Nutrition Intervention in AIDS Wasting

Start date: January 1998
Phase: Phase 4
Study type: Interventional

There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. In this clinical trial AIDS patients with wasting are randomized to one of three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition with progressive resistance training (PRT). In all participants, dietary intervention is maximized by weekly personalized counseling to address individual issues and concerns. Two primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be used to develop guidelines for standards of nutritional care among AIDS patient with the wasting syndrome.

NCT ID: NCT00006158 Completed - Clinical trials for AIDS Wasting Syndrome

AIDS Wasting in Women: Anabolic Effects of Testosterone

Start date: September 1998
Phase: Phase 2
Study type: Interventional

The study is a 6 month, placebo-controlled study of transdermal testosterone for women with HIV-associated weight loss. Women with AIDS wasting have been found to have low testosterone levels. This study is designed to test the efficacy of physiologic testosterone dosing to improve weight, muscle mass and quality of life indices, including energy level, appetite and libido, in androgen deficient women with AIDS wasting. After 6 months, all women receive open label transdermal testosterone for an additional 6 months.

NCT ID: NCT00006064 Completed - HIV Infections Clinical Trials

The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children

Start date: June 2000
Phase: N/A
Study type: Observational

The purpose of this study is to see how beginning or changing anti-HIV medications affects the body composition (weight, height, growth, body fat, and muscle mass, or fat and muscle distribution) of HIV-infected children. This study also looks at how changes in body composition relate to changes in viral load (level of HIV in the blood), CD4 cell counts, height, and weight in HIV-infected children. This study also compares changes in body composition to levels of cytokines (proteins in the body that affect some immune cells) in HIV-infected children who are beginning or changing anti-HIV therapy. Though studies have been done on adults, little is known about the effects of HIV infection and anti-HIV drugs on body composition in children. One theory is that changes in body composition can predict the failure of anti-HIV treatment. If this is true, body composition measurements can be as useful as CD4+ cell counts in determining drug effectiveness.

NCT ID: NCT00004664 Completed - HIV Infections Clinical Trials

Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting

Start date: June 1995
Phase: N/A
Study type: Interventional

OBJECTIVES: I. Evaluate the effect of aerobic exercise and progressive resistance plus megestrol acetate on lean body mass of patients with human immunodeficiency virus-related weight loss (HIV-wasting). II. Evaluate whether exercise acutely alters immune function. III. Evaluate whether long-term exercise improves immunocompetence. IV. Evaluate the accuracy of multifrequency bioelectrical impedance spectral analysis in measuring body composition. V. Assess the impact of these therapies on quality of life. VI. Evaluate the effect of these therapies on the balance of energy intake and energy expenditure.

NCT ID: NCT00002157 Completed - HIV Infections Clinical Trials

Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome

Start date: n/a
Phase: N/A
Study type: Interventional

To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2 doses. To gain safety and efficacy data from a broader base of patients with HIV-associated wasting in order to support Celgene's pivotal placebo-controlled study.

NCT ID: NCT00002127 Completed - HIV Infections Clinical Trials

A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome

Start date: n/a
Phase: Phase 2
Study type: Interventional

To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.

NCT ID: NCT00001079 Completed - HIV Infections Clinical Trials

A Study of Megestrol Acetate Alone or in Combination With Testosterone Enanthate Drug in the Treatment of HIV-Associated Weight Loss

Start date: n/a
Phase: Phase 2
Study type: Interventional

To test the hypothesis that the predominant accrual of fat rather than lean body mass (LBM) that occurs during treatment of HIV-associated wasting with megestrol acetate may be improved by treatment with megestrol acetate and testosterone enanthate in combination. Body wasting is an increasingly frequent AIDS-defining condition in individuals infected with HIV. Increasing caloric intake fails to consistently restore lean tissue patients with HIV associated weight loss. Megestrol acetate has been shown to stimulate appetite and weight gain in subjects with cancer and in those with HIV associated weight loss. However, the weight gained during treatment with megestrol acetate was predominantly or exclusively fat. An important factor is the preferential increase in body fat seen in both of these studies may have been due to hypogonadism that occurs as a result of treatment with megestrol acetate, a progestational agent. Hypogonadism is associated with an increase in body fat and a decrease in LBM. Concomitant testosterone replacement should substantially increase the amount of LBM accrued during megestrol acetate therapy. This study will determine whether anabolic potential can be realized when caloric intake is increased in the absence of concomitant hypogonadism.

NCT ID: NCT00001077 Completed - HIV Infections Clinical Trials

A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements

Start date: June 1996
Phase: N/A
Study type: Observational

To compare a caloric supplement containing peptides and medium-chain triglycerides, a caloric supplement containing whole protein and long-chain triglycerides, and no caloric supplement for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and mineral supplement.