HIV InfectionsNCT00001077
A Comparison of Two Caloric Supplements in the Prevention of Weight Loss in Patients With AIDS Who Take Daily Multivitamin and Mineral Supplements
An observational study of HIV Infections and HIV Wasting Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in United States.
Trial summary
To compare a caloric supplement containing peptides and medium-chain triglycerides, a caloric supplement containing whole protein and long-chain triglycerides, and no caloric supplement for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and mineral supplement. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, HIV Wasting Syndrome
- What is being tested?
- Multivitamin and mineral supplements, Peptamen and NuBasics
- Type of treatment
- Pill or oral medicine
- How many people
- 536 participants
- Where
- 17 sitesUnited States
- Study dates
- Jun 1996to Apr 1998
- Phase
- Observational
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: HIV-infected participants who take a daily multivitamin and mineral supplement
Who may be able to join
- Patients must have:
- HIV infection.
- Stable weight.
- CD4+ cell count <200 cells/mm3.
- Life expectancy of at least 6 months.
- Parent or legal guardian to sign written, informed consent for patients < 18 years old.
Who cannot join
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Active opportunistic infection, requiring acute treatment.
- Malignancy (other than stable cutaneous Kaposi's sarcoma that does not require systemic chemotherapy).
- Diabetes mellitus or other conditions requiring special dietary restrictions.
- Body mass index (BMI) >= 29.0 kg/m2.
Show all 34Show fewer
- Disorders or conditions that, in the treating clinician's opinion, may prevent adequate compliance with protocol requirements.
- Concurrent Medication:
- Excluded:
- Growth hormone.
- Megestrol acetate (Megace).
- Cyproheptadine (Periactin).
- Dronabinol (Marinol).
- Thalidomide.
- Anabolic steroids (e.g., nandrolone decanoate)(Deca-durabolin).
- Pharmacologic-dose corticosteroids (e.g., > 15 mg/day prednisone equivalent)
- NOTE:
- Men requiring testosterone replacement therapy for documented hypogonadism may be enrolled.
- Caloric nutritional supplements deemed by the clinician to promote weight gain or maintenance.
- Patients with the following prior condition are excluded:
- History of phenylketonuria.
- Prior Medication:
- Excluded within the past 2 weeks:
- Use of caloric nutritional supplements for more than 5 days deemed by the clinician to promote weight gain or maintenance.
- Excluded within the past 30 days:
- Growth hormone.
- Megestrol acetate (Megace).
- Cyproheptadine (Periactin).
- Dronabinol (Marinol).
- Thalidomide.
- Anabolic steroids (e.g., nandrolone decanoate)(Deca-durabolin)
- Pharmacologic-dose corticosteroids (e.g., > 15 mg/day prednisone equivalent).
- NOTE:
- Men requiring testosterone replacement therapy for documented hypogonadism may be enrolled.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Partners in Research - New Mexico
Albuquerque, New Mexico, 87131
Partners Research
Albuquerque, New Mexico, 87131
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Baltimore Trials
Baltimore, Maryland, 21201
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 80204
Wayne State Univ / WSU / DMC HIV / AIDS Program
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037
North Jersey Community Research Initiative
Newark, New Jersey, 07103
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
Community Consortium / UCSF
San Francisco, California, 94110
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
About this study
Official title: An Open-Label, Randomized, Three-Arm, Comparative Trial of a Caloric Supplement With Peptides and Medium-Chain Triglycerides Versus a Caloric Supplement With Whole Protein and Long-Chain Triglycerides Versus No Caloric Supplement for the Prevention of Weight Loss in Individuals With AIDS Who Take a Daily Multivitamin and Mineral Supplement
To compare a caloric supplement containing peptides and medium-chain triglycerides, a caloric supplement containing whole protein and long-chain triglycerides, and no caloric supplement for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and mineral supplement.
Read the detailed description
Patients will be randomized to one of 3 study arms:
Arm 1 - Peptamen drinks + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 2 - NuBasics drinks or equivalent amounts of NuBasics soups or bars + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 3 - Multivitamin and mineral supplement, taken in addition to regular diet for 4 months.
At months 0, 2, and 4, patients will be assessed for weight, body cell mass, patient-reported physical activity level, and dietary intake (by 24-hour dietary recall). At months 2 and 4, they will also be assessed for compliance with study regimen. Patients who complete their 4 month follow up visit will be provided with a 30 day supply of the caloric supplement of their choice (Peptamen or NuBasics) and a 30 day supply of the study multivitamin supplement.
- Conditions
- HIV Infections, HIV Wasting Syndrome
- Being tested
- Multivitamin and mineral supplements, Peptamen, NuBasics
- Keywords
- Weight Loss, Acquired Immunodeficiency Syndrome, Nutritional Support
- Medical subject headings
- HIV Infections, HIV Wasting Syndrome, Weight Loss, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamin and mineral supplementsDietary supplement
Oral tablets taken daily
PeptamenDietary supplement
Solution received daily
NuBasicsDietary supplement
Solution or dietary bar received daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months Receives: Dietary Supplement: Multivitamin and mineral supplements; Dietary Supplement: Peptamen | |
| 2 | Participants will receive NuBasics drinks or equivalent amounts of NuBasics soups or bars and daily multivitamin and mineral supplements, taken in addition to a regular diet for 4 months Receives: Dietary Supplement: Multivitamin and mineral supplements; Dietary Supplement: NuBasics | |
| 3 | Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months Receives: Dietary Supplement: Multivitamin and mineral supplements |
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 startJun 1996
- Primary completionApr 1998
- Study completionApr 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gilbert CL, Study chairWheeler D, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001077
- Sponsor's protocol ID
- CPCRA 038
- Other IDs
- 11588
- Status last verified
- Sep 2013
- First submitted
- 2 Nov 1999
- Last updated
- 1 Oct 2013
- Results posted
- No
Publications
Gibert CL, Muurahainen N, Collins G, Williams B, Raghavan S, Bartsch G, Wheeler D. Body composition in HIV-infected men and women in 1996-1997 (CPCRA 038). Int Conf AIDS. 1998;12:554 (abstract no 32169)
Williams SB, Collins G, Muurahainen N, Bartsch G, Gibert C, Raghavan SS, Wheeler D. Protein intake is associated with body cell mass in weight-stable HIV+ men with CD4 < 200 cells/mm3: CPCRA 038. Int Conf AIDS. 1998;12:841-2 (abstract no 42339)
Muurahainen N, Mulligan K. Clinical trials update in human immunodeficiency virus wasting. Semin Oncol. 1998 Apr;25(2 Suppl 6):104-11.
PubMed 9625392Muurahainen N, Collins G, Wheeler D, Mateo N, Madans M, Bartsch G, Gilbert C. Body cell mass (BCM) in HIV-infected (HIV+) males in the community programs for clinical research on AIDS (CPCRA) in 1996-1997. Int Conf AIDS. 1998;12:840 (abstract no 42333)
Gibert CL, Wheeler DA, Collins G, Madans M, Muurahainen N, Raghavan SS, Bartsch G. Randomized, controlled trial of caloric supplements in HIV infection. Terry Beirn Community Programs for Clinical Research on AIDS. J Acquir Immune Defic Syndr. 1999 Nov 1;22(3):253-9. doi: 10.1097/00126334-199911010-00006.
PubMed 10770345
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Three-Arm, Comparative Trial of a Caloric Supplement With Peptides and Medium-Chain Triglycerides Versus a Caloric Supplement With Whole Protein and Long-Chain Triglycerides Versus No Caloric Supplement for the Prevention of Weight Loss in Individuals With AIDS Who Take a Daily Multivitamin and Mineral Supplement
- ClinicalTrials.gov ID
- NCT00001077
- Acronym / sponsor ID
- CPCRA 038
- Conditions
- HIV Infections, HIV Wasting Syndrome
- Keywords
- Weight Loss, Acquired Immunodeficiency Syndrome, Nutritional Support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 1996
- Primary completion
- Apr 1998 (actual)
- Study completion
- Apr 1998 (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.
To compare a caloric supplement containing peptides and medium-chain triglycerides, a caloric supplement containing whole protein and long-chain triglycerides, and no caloric supplement for the prevention of weight loss in individuals with AIDS who take a daily multivitamin and mineral supplement.
Detailed description
Patients will be randomized to one of 3 study arms:
Arm 1 - Peptamen drinks + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 2 - NuBasics drinks or equivalent amounts of NuBasics soups or bars + multivitamin and mineral supplement, taken in addition to regular diet for 4 months Arm 3 - Multivitamin and mineral supplement, taken in addition to regular diet for 4 months.
At months 0, 2, and 4, patients will be assessed for weight, body cell mass, patient-reported physical activity level, and dietary intake (by 24-hour dietary recall). At months 2 and 4, they will also be assessed for compliance with study regimen. Patients who complete their 4 month follow up visit will be provided with a 30 day supply of the caloric supplement of their choice (Peptamen or NuBasics) and a 30 day supply of the study multivitamin supplement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Dietary Supplement: Multivitamin and mineral supplements, Dietary Supplement: PeptamenParticipants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months |
| 2 | – | Dietary Supplement: Multivitamin and mineral supplements, Dietary Supplement: NuBasicsParticipants will receive NuBasics drinks or equivalent amounts of NuBasics soups or bars and daily multivitamin and mineral supplements, taken in addition to a regular diet for 4 months |
| 3 | – | Dietary Supplement: Multivitamin and mineral supplementsParticipants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- HIV-infected participants who take a daily multivitamin and mineral supplement
Key inclusion criteria (6 listed)
- HIV infection.
- Stable weight.
- CD4+ cell count <200 cells/mm3.
- Life expectancy of at least 6 months.
- Parent or legal guardian to sign written, informed consent for patients < 18 years old.
Key exclusion criteria (34 listed)
- Active opportunistic infection, requiring acute treatment.
- Malignancy (other than stable cutaneous Kaposi's sarcoma that does not require systemic chemotherapy).
- Diabetes mellitus or other conditions requiring special dietary restrictions.
- Body mass index (BMI) >= 29.0 kg/m2.
- Disorders or conditions that, in the treating clinician's opinion, may prevent adequate compliance with protocol requirements.
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 |
|---|---|---|
| Multivitamin and mineral supplementsOral tablets taken daily | Dietary supplement | 1, 2, 3 |
| PeptamenSolution received daily | Dietary supplement | 1 |
| NuBasicsSolution or dietary bar received daily | Dietary supplement | 2 |
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 1 Oct 2013.
- BackgroundGibert CL, Muurahainen N, Collins G, Williams B, Raghavan S, Bartsch G, Wheeler D. Body composition in HIV-infected men and women in 1996-1997 (CPCRA 038). Int Conf AIDS. 1998;12:554 (abstract no 32169)
- BackgroundWilliams SB, Collins G, Muurahainen N, Bartsch G, Gibert C, Raghavan SS, Wheeler D. Protein intake is associated with body cell mass in weight-stable HIV+ men with CD4 < 200 cells/mm3: CPCRA 038. Int Conf AIDS. 1998;12:841-2 (abstract no 42339)
- Background: PubMed 9625392Muurahainen N, Mulligan K. Clinical trials update in human immunodeficiency virus wasting. Semin Oncol. 1998 Apr;25(2 Suppl 6):104-11.
- BackgroundMuurahainen N, Collins G, Wheeler D, Mateo N, Madans M, Bartsch G, Gilbert C. Body cell mass (BCM) in HIV-infected (HIV+) males in the community programs for clinical research on AIDS (CPCRA) in 1996-1997. Int Conf AIDS. 1998;12:840 (abstract no 42333)
- Background: PubMed 10770345Gibert CL, Wheeler DA, Collins G, Madans M, Muurahainen N, Raghavan SS, Bartsch G. Randomized, controlled trial of caloric supplements in HIV infection. Terry Beirn Community Programs for Clinical Research on AIDS. J Acquir Immune Defic Syndr. 1999 Nov 1;22(3):253-9. doi: 10.1097/00126334-199911010-00006.
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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.
Gilbert CL study chair
Wheeler D study chair
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and HIV Wasting Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites 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 6 inclusion and 34 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 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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.
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 NCT00001077, which also lists 5 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 1 Oct 2013.