NCT00095212

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2004

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 15, 2010

Completed
Last Updated

April 14, 2010

Status Verified

April 1, 2010

Enrollment Period

3.6 years

First QC Date

November 1, 2004

Results QC Date

January 21, 2010

Last Update Submit

April 9, 2010

Conditions

HIV Infection

Keywords

HIVwomenandrogenTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Lean Body Mass

    Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for lean body mass measured by dual energy absorptiometry (DEXA)scan.

    Baseline (time 0) to 18 months

Secondary Outcomes (10)

  • Bone Mineral Density of the Hip

    Baseline (time 0) to 18 months

  • Quality of Life/Depression: Becks Depression Inventory

    Baseline (time 0) to 18 months

  • Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function

    Baseline (time 0) to 18 months

  • Safety: Number of Subjects Reporting a Skin Reaction to the Patch

    Baseline (time 0) to 18 months

  • Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)

    Baseline (time 0) to 18 months

  • +5 more secondary outcomes

Study Arms (2)

1 Transdermal Testosterone (Patch)

ACTIVE COMPARATOR

300 micrograms applied twice a week

Drug: 1 Transdermal Testosterone (Patch)

2 Placebo Patch (identical in appearance)

PLACEBO COMPARATOR

placebo patch (0 micrograms of testosterone)applied twice a week

Drug: 2 Placebo Patch

Interventions

1 Transdermal Testosterone (Patch)DRUG

300 micrograms twice a week

1 Transdermal Testosterone (Patch)
2 Placebo PatchDRUG

Placebo patch (0 micrograms of testosterone) applied twice a week

2 Placebo Patch (identical in appearance)

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female 18 - 55
  • BMI less than or equal to 26
  • HIV-infected
  • Androgen deficient, with free testosterone \< 3 pg/mL
  • 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.

You may not qualify if:

  • Use of anabolic agent, including testosterone, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Dolan Looby SE, Collins M, Lee H, Grinspoon S. Effects of long-term testosterone administration in HIV-infected women: a randomized, placebo-controlled trial. AIDS. 2009 May 15;23(8):951-9. doi: 10.1097/QAD.0b013e3283299145.

    PMID: 19287303RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

Title
Steven Grinspoon, MD
Organization
Massachusetts General Hospital
sgrinspoon@partners.org
617 724 9109

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2004

First Posted

November 2, 2004

Study Start

September 1, 2004

Primary Completion

April 1, 2008

Study Completion

February 1, 2009

Last Updated

April 14, 2010

Results First Posted

March 15, 2010

Record last verified: 2010-04

Locations

US(1)