AIDS Wasting SyndromePhase 2NCT00006158
AIDS Wasting in Women: Anabolic Effects of Testosterone
A Phase 2 study testing Testosterone in people with AIDS Wasting Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- AIDS Wasting Syndrome
- What is being tested?
- Testosterone
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 1998to Dec 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- AIDS Wasting Syndrome
- Being tested
- Testosterone
- Keywords
- AIDS, HIV, weight loss, Wasting Syndrome, testosterone, androgen levels, hormones
- Medical subject headings
- HIV Wasting Syndrome, Acquired Immunodeficiency Syndrome, Weight Loss, Wasting Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2000 (estimated)
- Study startSep 1998
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AIDS Wasting SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Steven Grinspoon, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006158
- Sponsor's protocol ID
- anabole (completed)
- Other IDs
- DK54167
- Status last verified
- Feb 2010
- First submitted
- 8 Aug 2000
- Last updated
- 15 Feb 2010
- Results posted
- No
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.
PubMed 9709937Corcoran 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.
PubMed 10352167
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIDS Wasting in Women: Anabolic Effects of Testosterone
- ClinicalTrials.gov ID
- NCT00006158
- Acronym / sponsor ID
- anabole (completed)
- Conditions
- AIDS Wasting Syndrome
- Keywords
- AIDS, HIV, weight loss, Wasting Syndrome, testosterone, androgen levels, hormones
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Sep 1998
- Study completion
- Dec 2004 (actual)
- First posted
- 9 Aug 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2010.
- Background: PubMed 9709937Miller 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.
- Background: PubMed 10352167Corcoran 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.
Related trials for AIDS Wasting Syndrome
Recruiting
A Trial Testing a Two-way SMS Platform to Recognize and Prevent Wasting Among HIV-infected and HIV-exposed Uninfected Children in Kenya
Malnutrition in Children, Children Exposed to HIV
Not yet recruiting
Building Opportunities for Nurturing Care to Enhance Child Development in Eastern and Southern Africa
Neurodevelopment, Child Growth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Grinspoon, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone in people with AIDS Wasting Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006158, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2010.