NCT00006158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2000

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

February 15, 2010

Status Verified

February 1, 2010

First QC Date

August 8, 2000

Last Update Submit

February 12, 2010

Conditions

AIDS Wasting Syndrome

Keywords

AIDSHIVweight lossWasting Syndrometestosteroneandrogen levelshormones

Interventions

TestosteroneDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • 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.

    PMID: 9709937BACKGROUND

  • 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.

    PMID: 10352167BACKGROUND

MeSH Terms

Conditions

HIV Wasting SyndromeAcquired Immunodeficiency SyndromeWeight LossWasting Syndrome

Interventions

Testosterone

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesNutrition DisordersImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Steven Grinspoon, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 8, 2000

First Posted

August 9, 2000

Study Start

September 1, 1998

Study Completion

December 1, 2004

Last Updated

February 15, 2010

Record last verified: 2010-02

Locations

US(1)