AIDS Wasting in Women: Anabolic Effects of Testosterone

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ClinicalTrials.gov Identifier: NCT00006158

Recruitment Status : Completed

First Posted : August 9, 2000

Last Update Posted : February 15, 2010

Sponsor:

Information provided by:

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

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
AIDS Wasting Syndrome	Drug: Testosterone	Phase 2

Study Design


Study Type :	Interventional (Clinical Trial)
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	September 1998
Actual Study Completion Date :	December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Testosterone

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted:	August 9, 2000 Key Record Dates
Last Update Posted:	February 15, 2010
Last Verified:	February 2010

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:


Cachexia Wasting Syndrome HIV Wasting Syndrome Emaciation Weight Loss Body Weight Changes Body Weight Signs and Symptoms Metabolic Diseases Nutrition Disorders HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents

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