HIV InfectionsPhase 2NCT00000925
A Study to Evaluate High Protein Supplementation in HIV-Positive Patients With Stable Weight Loss
A Phase 2 study testing Optimune oral nutritional supplement in people with HIV Infections and HIV Wasting Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether a high-quality protein food supplement will help HIV-positive patients maintain, and possibly gain, muscle mass. Many HIV-positive patients lose weight that they are then unable to regain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, HIV Wasting Syndrome
- What is being tested?
- Optimune oral nutritional supplement
- Type of treatment
- Pill or oral medicine
- How many people
- 56 participants
- Where
- 19 sitesin 2 countries
- Study dates
- May 1999to Jun 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are HIV-positive.
- Are at least 18 years old.
- Have an HIV level less than 5,000 copies/ml within 30 days of study entry.
- Have lost weight in the past year, but your weight has remained fairly stable in the 2 months prior to enrollment.
- Are expected to live for at least 6 months.
- Are usually able to eat enough to maintain your present weight.
- Are able to complete a 3-day food diary.
Who cannot join
- You will not be eligible for this study if you:
- Have gained a significant amount of weight in the past 2 months.
- Have any opportunistic (HIV-associated) infections.
- Are unable to eat enough food for any reason, or are on tube feeding.
- Have nausea, diarrhea, or vomiting in the 14 days prior to study entry.
- Are being treated for diabetes.
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- Are receiving chemotherapy or radiation therapy to treat cancer.
- Are pregnant or breast-feeding.
- Are allergic to milk or mangoes.
- Have an implanted defibrillator.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
Queens Med Ctr
Honolulu, Hawaii, 96816
Univ of Hawaii
Honolulu, Hawaii, 96816
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
UCLA CARE Ctr
Los Angeles, California, 90095
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Chelsea Ctr
New York, New York, 10021
Cornell Univ Med Ctr
New York, New York, 10021
Philadelphia Veterans Administration Med Ctr
Philadelphia, Pennsylvania, 19104
Univ of Rochester Medical Center
Rochester, New York, 14642
San Francisco Gen Hosp
San Francisco, California, 941102859
Univ of Washington
Seattle, Washington, 98104
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112
Stanford Univ Med Ctr
Stanford, California, 943055107
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
Official title: Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss
The purpose of this study is to determine whether a high-quality protein food supplement will help HIV-positive patients maintain, and possibly gain, muscle mass.
Many HIV-positive patients lose weight that they are then unable to regain. This may be because patients are not eating enough protein or are not eating the right kinds of protein. The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the amount of protein lost due to HIV infection. This study gives patients high-quality protein food supplements to help them maintain and/or gain weight.
Read the detailed description
In many HIV-infected individuals with prior weight loss, the failure to regain weight and lean tissue is at least in part the consequence of inadequate protein intake or ingestion of a poor-quality protein rather than total caloric intake. Dietary sources of protein are presumably inadequate to meet the high metabolic needs caused by HIV infection. To achieve a target protein intake in the range (1.5 to 2.0 g/kg/day) demonstrated in other catabolic diseases necessary to achieve positive nitrogen balance and to generate substantial anabolic effects, this study will administer a supplement containing high-quality protein.
Two groups of 28 patients each are randomly chosen to receive either an oral nutritional supplement (Optimune) containing increased amounts of high-quality protein (whey), which is rich in cysteine and glutamine, or an isocaloric, identical-tasting supplement without added whey protein or amino acid supplementation. Weight, body composition, anthropometry, dietary intake, and general physical health are assessed at baseline and at Weeks 6 and 12. Plasma cysteine, glutathione, C-reactive protein, and prealbumin, along with urine IL-6, sTNFrII, and IL-1ra, are assessed at baseline and at Week 12.
- Conditions
- HIV Infections, HIV Wasting Syndrome
- Being tested
- Optimune oral nutritional supplement
- Keywords
- Dietary Proteins, HIV Wasting Syndrome
- Medical subject headings
- HIV Infections, HIV Wasting Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimune oral nutritional supplementDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startMay 1999
- Primary completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 56 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kathleen Mulligan, MD, Study chairBruce R. Bistrian, MD, Study chairFred R. Sattler, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000925
- Sponsor's protocol ID
- ACTG 392
- Other IDs
- 11349
- Status last verified
- Jul 2013
- First submitted
- 2 Nov 1999
- Last updated
- 29 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of High Protein Supplementation in HIV-1-Positive Subjects With Stable Weight Loss
- ClinicalTrials.gov ID
- NCT00000925
- Acronym / sponsor ID
- ACTG 392
- Conditions
- HIV Infections, HIV Wasting Syndrome
- Keywords
- Dietary Proteins, HIV Wasting Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- May 1999
- Primary completion
- Jun 2003 (actual)
- First posted
- 31 Aug 2001 (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 purpose of this study is to determine whether a high-quality protein food supplement will help HIV-positive patients maintain, and possibly gain, muscle mass.
Many HIV-positive patients lose weight that they are then unable to regain. This may be because patients are not eating enough protein or are not eating the right kinds of protein. The protein eaten in foods (such as meat, eggs, or beans) may not be able to make up for the amount of protein lost due to HIV infection. This study gives patients high-quality protein food supplements to help them maintain and/or gain weight.
Detailed description
In many HIV-infected individuals with prior weight loss, the failure to regain weight and lean tissue is at least in part the consequence of inadequate protein intake or ingestion of a poor-quality protein rather than total caloric intake. Dietary sources of protein are presumably inadequate to meet the high metabolic needs caused by HIV infection. To achieve a target protein intake in the range (1.5 to 2.0 g/kg/day) demonstrated in other catabolic diseases necessary to achieve positive nitrogen balance and to generate substantial anabolic effects, this study will administer a supplement containing high-quality protein.
Two groups of 28 patients each are randomly chosen to receive either an oral nutritional supplement (Optimune) containing increased amounts of high-quality protein (whey), which is rich in cysteine and glutamine, or an isocaloric, identical-tasting supplement without added whey protein or amino acid supplementation. Weight, body composition, anthropometry, dietary intake, and general physical health are assessed at baseline and at Weeks 6 and 12. Plasma cysteine, glutathione, C-reactive protein, and prealbumin, along with urine IL-6, sTNFrII, and IL-1ra, are assessed at baseline and at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (8 listed)
- Are HIV-positive.
- Are at least 18 years old.
- Have an HIV level less than 5,000 copies/ml within 30 days of study entry.
- Have lost weight in the past year, but your weight has remained fairly stable in the 2 months prior to enrollment.
- Are expected to live for at least 6 months.
Key exclusion criteria (10 listed)
- Have gained a significant amount of weight in the past 2 months.
- Have any opportunistic (HIV-associated) infections.
- Are unable to eat enough food for any reason, or are on tube feeding.
- Have nausea, diarrhea, or vomiting in the 14 days prior to study entry.
- Are being treated for diabetes.
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 |
|---|---|---|
| Optimune oral nutritional supplement | 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 29 Jul 2013.
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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.
Kathleen Mulligan, MD study chair
Bruce R. Bistrian, MD study chair
Fred R. Sattler, MD study chair
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Optimune oral nutritional supplement in people with HIV Infections and HIV Wasting Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 19 sites in 2 countries.
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 8 inclusion and 10 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 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Puerto Rico. 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?
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 29 Jul 2013.