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| ID | Type | Description | Link |
|---|---|---|---|
| 11588 | Registry Identifier | DAIDS ES |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Participants will receive peptamen drinks and multivitamin and mineral supplements, taken in addition to a regular diet for 4 months |
| |
| 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 |
| |
| 3 | Participants will receive multivitamin and mineral supplements, taken in addition to a regular diet for 4 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivitamin and mineral supplements | Dietary Supplement | Oral tablets taken daily |
|
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
NOTE:
Patients with the following prior condition are excluded:
Prior Medication:
Excluded within the past 2 weeks:
Excluded within the past 30 days:
NOTE:
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HIV-infected participants who take a daily multivitamin and mineral supplement
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| Name | Affiliation | Role |
|---|---|---|
| Gilbert CL | Study Chair | |
| Wheeler D | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Consortium / UCSF | San Francisco | California | 94110 | United States | ||
| Denver CPCRA / Denver Public Hlth |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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) | ||
| Background | 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) | ||
| 9625392 | Background | Muurahainen N, Mulligan K. Clinical trials update in human immunodeficiency virus wasting. Semin Oncol. 1998 Apr;25(2 Suppl 6):104-11. | |
| Background | Muurahainen 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) |
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Blood collection
| Peptamen | Dietary Supplement | Solution received daily |
|
| NuBasics | Dietary Supplement | Solution or dietary bar received daily |
|
| Denver |
| Colorado |
| 80204 |
| United States |
| Washington Reg AIDS Prog / Dept of Infect Dis | Washington D.C. | District of Columbia | 20422 | United States |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | United States |
| Rush Presbyterian - Saint Luke's Med Ctr | Chicago | Illinois | 60612 | United States |
| AIDS Research Alliance - Chicago | Chicago | Illinois | 60657 | United States |
| Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | New Orleans | Louisiana | 70112 | United States |
| Baltimore Trials | Baltimore | Maryland | 21201 | United States |
| Wayne State Univ / WSU / DMC HIV / AIDS Program | Detroit | Michigan | 48201 | United States |
| Henry Ford Hosp | Detroit | Michigan | 48202 | United States |
| Southern New Jersey AIDS Cln Trials / Dept of Med | Camden | New Jersey | 08103 | United States |
| North Jersey Community Research Initiative | Newark | New Jersey | 07103 | United States |
| Partners in Research - New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Partners Research | Albuquerque | New Mexico | 87131 | United States |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | New York | New York | 10037 | United States |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | Portland | Oregon | 97210 | United States |
| Philadelphia FIGHT | Philadelphia | Pennsylvania | 19107 | United States |
| 10770345 | Background | 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. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D019247 | HIV Wasting Syndrome |
| D015431 | Weight Loss |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019282 | Wasting Syndrome |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009748 | Nutrition Disorders |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012897 | Slow Virus Diseases |
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| ID | Term |
|---|---|
| C067316 | Geritol |
| C073248 | Peptamen |
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