Androgen Effects in HIV-Infected Women - Full Text View

Sponsored by:	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:	NCT00095212

Purpose

Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause critical reductions in physical functioning and reduced bone density. The effects of long-term androgen therapy on lean body mass, bone density and other clinical endpoints including quality of life, functional status and neurocognitive function in HIV-infected women are not known.

Condition	Intervention
HIV Infection HIV Wasting Syndrome	Drug: testosterone Drug: Placebo

MedlinePlus related topics: AIDS

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Androgen Effects in HIV-Infected Women

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

Primary Outcome Measures:

Lean body mass [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

strength [ Time Frame: 18 months ] [ Designated as safety issue: No ]
bone density [ Time Frame: 18 months ] [ Designated as safety issue: No ]
quality of life [ Time Frame: 18 months ] [ Designated as safety issue: No ]
neurocognitive function [ Time Frame: 18 months ] [ Designated as safety issue: No ]
safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment:	25
Study Start Date:	September 2004
Estimated Study Completion Date:	May 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator testosterone patch 300 mcg 2x/week	Drug: testosterone 300 mcg 2x/week Drug: testosterone 300 mcg patch 2x/week
2: Placebo Comparator placebo patch	Drug: Placebo Placebo patch

Detailed Description:

We will perform an 18-month randomized, double-blinded, placebo-controlled study among relatively androgen deficient women with AIDS wasting, to determine the effects of testosterone administration on lean body mass. The administered dose will be 300 micrograms twice a week vs. identical placebo in the form of a transdermal preparation. Secondary endpoints include effects on bone density, quality of life, neurocognitive function and menstrual function. Open label administration at 300 micrograms twice a week will be initiated for 12 months in all subjects following the randomized portion of the study.Assuming a 15% dropout rate and 25 randomized patients, the probability is 80 percent that the study will detect a treatment difference at a two sided 5.000 percent significance level, if the true difference between the treatments is 2.7 kg. This is based on the assumption that the standard deviation of the response variable, lean body mass by DEXA, is 2.3 kg, as was shown by Choi et al1 over 12 weeks in HIV-infected women at the same dose of 300 ug 2x/week.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female (age 18-50)
HIV-infected
Androgen deficient, with free testosterone < 3 pg/mL
Weight < 90% Ideal Body Weight (IBW) or weight loss > 10% or weight loss > 5% over prior 6 months
Stable antiretroviral regimen for 3 months prior to study
Tubal ligation, hysterectomy, or verbalized understanding of appropriate barrier contraception methods. Subjects will be counseled in appropriate barrier contraception methods and the counseling will be documented.

Exclusion Criteria:

Use of anabolic agent, including testosterone, growth hormone (GH) or other preparations within 3 months of the study.
Use of megestrol acetate within 3 months of the study
Use of estrogen or any preparation known to affect bone density or bone turnover. This includes oral contraceptives, depo provera or combined progesterone-estrogen injections, and transdermal contraceptive patches.
Pregnant or breast-feeding
Hgb < 9.0 mg/dL
Current participation in another research study conducted by this investigator or past participation in the DHEA study funded by the same grant as this protocol.
Creatinine > 1.5 mg/dL
25-OHD level < the normal range
Calcium level > the normal range
FSH level > 25 mIU/ml (if amenorrheic)
History of congested heart failure, unstable angina, deep vein thrombosis, breast cancer, or sleep apnea.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095212

Locations

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

Sponsors and Collaborators

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

More Information

Responsible Party:	MGH ( Steven Grinspoon, M.D., Principal Investigator )
Study ID Numbers:	DK54167
Study First Received:	November 1, 2004
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00095212
Health Authority:	United States: Food and Drug Administration

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

HIV
HIV wasting syndrome
women
androgen
Treatment Experienced

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Metabolic Diseases
HIV Wasting Syndrome
Acquired Immunodeficiency Syndrome
Methyltestosterone
Immunologic Deficiency Syndromes
Testosterone 17 beta-cypionate
Virus Diseases

Testosterone
HIV Infections
Sexually Transmitted Diseases
Nutrition Disorders
Wasting Syndrome
Metabolic disorder
Retroviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Disease
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Infection

Hormones
Pharmacologic Actions
Anabolic Agents
Pathologic Processes
Therapeutic Uses
Syndrome
Lentivirus Infections
Androgens

ClinicalTrials.gov processed this record on January 16, 2009