- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006158
AIDS Wasting in Women: Anabolic Effects of Testosterone
February 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1210/jcem.83.8.5051.
- 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. doi: 10.1056/NEJM199906033402207. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 1998
Study Completion (ACTUAL)
December 1, 2004
Study Registration Dates
First Submitted
August 8, 2000
First Submitted That Met QC Criteria
August 8, 2000
First Posted (ESTIMATE)
August 9, 2000
Study Record Updates
Last Update Posted (ESTIMATE)
February 15, 2010
Last Update Submitted That Met QC Criteria
February 12, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Nutrition Disorders
- Body Weight
- Body Weight Changes
- HIV Infections
- Emaciation
- Weight Loss
- Wasting Syndrome
- Cachexia
- HIV Wasting Syndrome
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Androgens
- Testosterone
Other Study ID Numbers
- anabole (completed)
- DK54167
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on AIDS Wasting Syndrome
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Endo PharmaceuticalsQuintiles, Inc.CompletedHIV Infections | Anorexia | Cachexia | HIV Wasting Syndrome | AIDS Wasting SyndromeUnited States, India, South Africa
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National Taiwan University HospitalCompleted
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National Taiwan University HospitalUnknownMalnutrition | Body Composition | Nutritional WastingTaiwan
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NYU Langone HealthWithdrawnSIADH | Cerebral Hyponatremia | Cerebral Salt-wasting Syndrome | Reset Hypothalamic OsmostatUnited States
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National Taiwan University HospitalUnknownPeritoneal Dialysis | Wasting and MalnutritionTaiwan
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The Hospital for Sick ChildrenMinistry of Health, Malawi; Nutriset; Schlumberger Foundation; Friends of Sick...RecruitingSevere Acute Malnutrition | Severe WastingMalawi
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Johns Hopkins UniversityWithdrawn
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Harvard School of Public Health (HSPH)London School of Economics and Political ScienceCompletedPregnancy
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University Hospital, Basel, SwitzerlandRecruitingMuscle Wasting in Critically IllSwitzerland
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Assiut UniversityNot yet recruitingChronic Wasting Disease of Elk and Deer | Injury; Knee, Meniscus, Old Injury or Tear
Clinical Trials on Testosterone
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VA Office of Research and DevelopmentHunter Holmes McGuire VA Medical CenterCompleted
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Men's Health BostonCompletedHypogonadism, Male | Testosterone DeficiencyUnited States
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Leonard S. Marks, M.D.Watson Pharmaceuticals; Solvay PharmaceuticalsCompletedMen With Low Testosterone LevelsUnited States
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Charles Drew University of Medicine and ScienceCompletedStress Urinary IncontinenceUnited States
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Yale UniversityDendreonRecruitingMetastatic Castration-resistant Prostate CancerUnited States
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American Hip InstituteWithdrawnArthroplasty, Replacement, HipUnited States
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VA Office of Research and DevelopmentVirginia Commonwealth UniversityCompleted
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University of PennsylvaniaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted