Phase II Randomized Study of Physiologic Testosterone Replacement in Premenopausal, HIV-Positive Women

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, May 1998

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Charles Drew University of Medicine and Science
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004400

Purpose

OBJECTIVES: I. Determine whether physiologic testosterone replacement can increase fat-free mass, therefore contributing to weight maintenance, improved muscle function, and quality of life in HIV-infected women. II. Examine the mechanism of testosterone-induced increase in fat-free mass.

Condition	Intervention	Phase
HIV Infections Cachexia	Drug: testosterone	Phase II

MedlinePlus related topics: AIDS

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	56
Study Start Date:	April 1997

Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to one of three arms.

Arm I: Patients receive two placebo transdermal patches applied twice a week (every 3-4 days).

Arm II: Patients receive one testosterone transdermal patch and one placebo transdermal patch applied twice a week (every 3-4 days).

Arm III: Patients receive two testosterone transdermal patches applied twice a week (every 3-4 days).

Patients receive 12 weeks of treatment in the absence of adverse reaction or health deterioration. Patients are followed on day 1, every 2 weeks during treatment, and at the end of the recovery period. Quality of life is assessed before treatment begins and at weeks 6 and 12.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically confirmed premenopausal HIV-positive women who have experienced 5-15% weight loss

--Prior/Concurrent Therapy--

Endocrine therapy: At least 3 months since megestrol At least 3 months since anabolic or androgenic steroids At least 3 months since oral contraceptives At least 3 months since Depo-Provera No concurrent hormone replacement therapy
Other: Concurrent retroviral or protease inhibitors allowed, dosage must be stable At least 3 months since ketoconazole At least 6 weeks since the initiation of protease inhibitors

--Patient Characteristics--

Hepatic: No significant liver disease SGOT/SGPT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Bilirubin no greater than 2 mg/dL No medical complications due to alcohol abuse
Renal: Not specified
Cardiovascular: No significant cardiovascular disease No uncontrolled hypertension
Other: Testosterone level (early morning) less than 30 ng/dL Normal gastrointestinal function as indicated by: Absence of diarrhea Normal D-xylose absorption test No acute opportunistic infections or infectious illness No malignant disease No history of breast cancer No history of endometrial cancer No fever of known or unknown origin No unremitting diarrhea defined as: At least 4 watery stools per day OR More than 4 watery stools recently OR Acute change in stool habit with fever No significant respiratory disease No diabetes No illicit drugs within the past 6 months No history of hyperandrogenic disorders such as: Hirsutism Polycystic ovary disease Not pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004400

Locations

United States, California
Charles R. Drew University of Medicine and Science	Recruiting
Los Angeles, California, United States, 90059
Contact: Shalender Bhasin 213-563-9353
Los Angeles County Harbor-UCLA Medical Center	Recruiting
Torrance, California, United States, 90509
Contact: G. Beall 310-222-2444
United States, Missouri
Washington University School of Medicine	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: K. Yarashaski 314-362-9700

Sponsors and Collaborators

FDA Office of Orphan Products Development

Charles Drew University of Medicine and Science

Investigators

Study Chair:

Shalender Bhasin

Charles Drew University of Medicine and Science

More Information

No publications provided

Study ID Numbers:	199/13251, CDUMS-FDR001397
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004400 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

cachexia
disease-related problem/condition
human immunodeficiency virus infection
immunologic disorders and infectious disorders

nutrition
quality of life
rare disease
viral infection

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cachexia
Quality of Life
Hormones
Body Weight
Signs and Symptoms
Weight Loss
Body Weight Changes
Retroviridae Infections
Antineoplastic Agents, Hormonal
Acquired Immunodeficiency Syndrome

Rare Diseases
Emaciation
Methyltestosterone
Immunologic Deficiency Syndromes
Testosterone 17 beta-cypionate
Virus Diseases
Testosterone
Anabolic Agents
HIV Seropositivity
HIV Infections
Sexually Transmitted Diseases
Androgens

Additional relevant MeSH terms:

Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cachexia
Infection
Hormones
Body Weight
Signs and Symptoms
Therapeutic Uses
Weight Loss
Body Weight Changes
Retroviridae Infections
RNA Virus Infections

Antineoplastic Agents, Hormonal
Immune System Diseases
Acquired Immunodeficiency Syndrome
Emaciation
Methyltestosterone
Pharmacologic Actions
Immunologic Deficiency Syndromes
Testosterone 17 beta-cypionate
Virus Diseases
Anabolic Agents
Testosterone
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Androgens

ClinicalTrials.gov processed this record on May 07, 2009