AIDS Wasting in Women: Anabolic Effects of Testosterone

This study has been completed.

Sponsor:

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT00006158

First received: August 8, 2000

Last updated: February 12, 2010

Last verified: February 2010

History of Changes

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 2


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

Resource links provided by NLM:

Drug Information available for: Testosterone propionate Methyltestosterone Testosterone cypionate Testosterone 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.


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:


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

ClinicalTrials.gov processed this record on March 03, 2015

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