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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
AIDS Wasting Syndrome | Drug: Testosterone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | September 1998 |
Actual Study Completion Date : | December 2004 |


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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Steven Grinspoon, MD | Massachusetts General Hospital |
Publications:
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 |