AIDS Wasting in Women: Anabolic Effects of Testosterone

This study has been completed.

First Received on August 8, 2000. Last Updated on February 12, 2010 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00006158

Purpose

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.

Condition	Intervention	Phase
AIDS Wasting Syndrome	Drug: Testosterone	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Weight Control

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date:	September 1998
Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Females using acceptable form of birth control during study, including barrier contraception or IUD but excluding oral contraceptives or Depo-Provera
Documented HIV infection
Free testosterone level 3.0 pg/mL
Weight < 90% or weight loss > 10% of pre-illness weight

Exclusion Criteria:

Pregnant or actively seeking pregnancy
Breast feeding
New opportunistic infection diagnosed within 4 weeks of the study
Requiring parenteral nutrition or pharmacologic glucocorticoid therapy
Intractable diarrhea (6 stools/day)
Androgen, estrogen, progestational derivative, or glucocorticoid administration within 3 months of the study, including Megace
New retroviral therapy within 6 weeks of study
SGOT > 5 X normal and/or clinically significant liver disease
Creatinine > 2.0 mg/dL and/or clinically significant renal disease
Hgb < 8.0 g/dL
Active substance abuse or alcoholism

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006158

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Steven Grinspoon, MD

Massachusetts General Hospital

More Information

Publications:

Miller K, Corcoran C, Armstrong C, Caramelli K, Anderson E, Cotton D, Basgoz N, Hirschhorn L, Tuomala R, Schoenfeld D, Daugherty C, Mazer N, Grinspoon S. Transdermal testosterone administration in women with acquired immunodeficiency syndrome wasting: a pilot study. J Clin Endocrinol Metab. 1998 Aug;83(8):2717-25.

Corcoran C, Grinspoon S. Treatments for wasting in patients with the acquired immunodeficiency syndrome. N Engl J Med. 1999 Jun 3;340(22):1740-50. Review. No abstract available.

ClinicalTrials.gov Identifier:	NCT00006158 History of Changes
Other Study ID Numbers:	anabole (completed), DK54167
Study First Received:	August 8, 2000
Last Updated:	February 12, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

AIDS
HIV
weight loss
Wasting Syndrome

testosterone
androgen levels
hormones

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
Wasting Syndrome
HIV Wasting Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Metabolic Diseases
Nutrition Disorders

Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 12, 2012