HIV Wasting SyndromePhase 4NCT00006167
Nutrition Intervention in AIDS Wasting
A Phase 4 study testing oxandrolone and Progressive Resistance Training in people with HIV Wasting Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Wasting Syndrome
- What is being tested?
- oxandrolone and Progressive Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to Aug 2000
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Loss of 10% of usual body weight, OR loss of 5% of usual body weight within the previous 6 months, OR BMI20kg/m2. If the candidate is taking a protease inhibitor, he/she must have not regained weight since initiating the medication over a period of at least 4 weeks prior to screening.
- Documented HIV-positive
- Able to eat
- English-speaking
- Compliance with medical regimens
- For heterosexually active women: willingness to use an effective means of birth control
- Patient and physician not planning to start new treatments for HIV infection or weight loss during the 12 weeks of study.
Who cannot join
- Vomiting 1 time/day or diarrhea 4 times/day on average in the previous week
- Fever 101 F within the previous week
- Receiving induction treatment for one of the following (new diagnosis or recurrence within 4 weeks):
- Pneumocystis carinii pneumonia Cryptococcal meningitis Cytomegalovirus retinitis or pneumonitis Toxoplasmosis Mycobacterium avium complex Visceral Kaposi's Sarcoma Lymphoma Pulmonary tuberculosis
- Received corticosteroids, estrogens, progesterones, androgens, oral anticoagulants, or growth hormone within the previous three months
- History of life-threatening reaction to oxandrolone or testosterone
Show all 13Show fewer
- Currently pregnant
- History of congestive heart failure, myocardial infarction, angina/coronary artery disease, uncontrolled hypertension, cerebrovascular accident, hepatic failure, bleeding disorder, diabetes, nephrotic syndrome, cancer of the breast or prostate, or hypercalcemia
- Milk product allergy
- Current use of injected drugs
- Participation in an exercise program or strength training within the previous 4 weeks
- Any medical condition which renders the participant physically incapable of performing strength exercises
- Serum total testosterone level at least 300ng/ml, unless patient and primary physician prepared to begin testosterone injections concurrent with study enrollment (men only).
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Medicine
Boston, Massachusetts, 02111
About this study
There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. In this clinical trial AIDS patients with wasting are randomized to one of three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition with progressive resistance training (PRT). In all participants, dietary intervention is maximized by weekly personalized counseling to address individual issues and concerns. Two primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be used to develop guidelines for standards of nutritional care among AIDS patient with the wasting syndrome.
- Conditions
- HIV Wasting Syndrome
- Being tested
- oxandrolone, Progressive Resistance Training
- Keywords
- oxandrolone, AIDS wasting, strength training, progressive resistance training, exercise, dietary intervention
- Medical subject headings
- HIV Wasting Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxandroloneDrug
Progressive Resistance TrainingBehavioural
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 startJan 1998
- Study completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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 4
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Sherwood Gorbach, MD, Principal investigator, Tufts UniversityAbby Shevitz, MD, Study director, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006167
- Sponsor's protocol ID
- NIAW (completed)
- Other IDs
- DK51011
- Status last verified
- Jan 2010
- First submitted
- 8 Aug 2000
- Last updated
- 13 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Intervention in AIDS Wasting
- ClinicalTrials.gov ID
- NCT00006167
- Acronym / sponsor ID
- NIAW (completed)
- Conditions
- HIV Wasting Syndrome
- Keywords
- oxandrolone, AIDS wasting, strength training, progressive resistance training, exercise, dietary intervention
- Phase
- Phase 4
- 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
- Jan 1998
- Study completion
- Aug 2000
- 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.
There are no guidelines for appropriate nutritional management of weight loss or wasting in HIV infection. Some treatments may increase weight, but without improving muscle mass or quality of life. In this clinical trial AIDS patients with wasting are randomized to one of three nutritional strategies and studied over a 12-week period: 1) optimal oral nutrition with counseling and protein and calorie supplementation, and a placebo pill; 2) optimal oral nutrition with the oral androgen, oxandrolone at 20 mg daily; and 3) optimal oral nutrition with progressive resistance training (PRT). In all participants, dietary intervention is maximized by weekly personalized counseling to address individual issues and concerns. Two primary outcomes are assessed: thigh muscle mass and quality of life. Our findings can be used to develop guidelines for standards of nutritional care among AIDS patient with the wasting syndrome.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Loss of 10% of usual body weight, OR loss of 5% of usual body weight within the previous 6 months, OR BMI20kg/m2. If the candidate is taking a protease inhibitor, he/she must have not regained weight since initiating the medication over a period of at least 4 weeks prior to screening.
- Documented HIV-positive
- Able to eat
- English-speaking
- Compliance with medical regimens
Key exclusion criteria (13 listed)
- Vomiting 1 time/day or diarrhea 4 times/day on average in the previous week
- Fever 101 F within the previous week
- Receiving induction treatment for one of the following (new diagnosis or recurrence within 4 weeks):
- Pneumocystis carinii pneumonia Cryptococcal meningitis Cytomegalovirus retinitis or pneumonitis Toxoplasmosis Mycobacterium avium complex Visceral Kaposi's Sarcoma Lymphoma Pulmonary tuberculosis
- Received corticosteroids, estrogens, progesterones, androgens, oral anticoagulants, or growth hormone within the previous three months
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 |
|---|---|---|
| oxandrolone | Drug | – |
| Progressive Resistance Training | Behavioural | – |
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 13 Jan 2010.
Related trials for HIV 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.
Sherwood Gorbach, MD principal investigator
Tufts University
Abby Shevitz, MD study director
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oxandrolone and Progressive Resistance Training in people with HIV 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 7 inclusion and 13 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 13 Jan 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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 13 Jan 2010.