HIV InfectionsNCT00000873
A Study on the Effect of High-Calorie Infant Formula on Growth and Nutrition in HIV-Infected Infants
A study testing Infant Formula in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 72 sites in 4 countries.
Trial summary
This study examines the effects of an infant formula containing increased calories, as compared to commercial formulas, when given during the first 6 months of life. It will examine effects on growth, disease progress, immune system, and quality of life of infected infants. Read more about this study
- Who is it for?
- Ages 1 day to 17 daysHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Infant Formula
- How many people
- 2,400 participants
- Where
- 72 sitesin 4 countries
- Study dates
- Start not givento Sep 2005
- Phase
- Interventional
- 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 1 day to 17 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children may be eligible for this study if they:
- Are 1 to 17 days old. (This study has been changed. Originally, infants 1 to 15 days old were eligible for this study.)
- Weigh 4 or more pounds.
- Were born to an HIV-positive mother.
- Have a caregiver willing to measure and keep records of infant's food intake.
Who cannot join
- Children will not be eligible for this study if they:
- Are breast-fed.
- Have certain disorders, including the inability to feed by mouth, or a life-threatening condition.
- Take medication which affects growth.
Trial locations and contacts
72 sites in 4 countries.
72 sites in 4 countries
United States62 sites
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
Med College of Georgia
Augusta, Georgia, 30912
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
Children's Hosp of Boston
Boston, Massachusetts, 021155724
SUNY - Brooklyn
Brooklyn, New York, 11203
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
Camden, New Jersey, 08103
Med Univ of South Carolina
Charleston, South Carolina, 294253312
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
Univ of South Carolina School of Med
Columbia, South Carolina, 29203
The Med Ctr Inc
Columbus, Georgia, 31901
Columbus Children's Hosp
Columbus, Ohio, 432052696
Children's Med Ctr of Dallas
Dallas, Texas, 75235
Children's Hosp of Denver
Denver, Colorado, 802181088
Children's Hosp of Michigan
Detroit, Michigan, 48201
Duke Univ Med Ctr
Durham, North Carolina, 277103499
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, 27710
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
North Broward Hosp District
Fort Lauderdale, Florida, 33311
Univ of Florida Gainesville
Gainesville, Florida, 32610
North Shore Univ Hosp
Great Neck, New York, 11021
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
Univ of Miami (Pediatric)
Miami, Florida, 33161
Univ of South Alabama
Mobile, Alabama, 36604
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
St Peter's Med Ctr
New Brunswick, New Jersey, 08903
Yale Univ Med School
New Haven, Connecticut, 06504
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Cornell Univ Med College
New York, New York, 10021
Metropolitan Hosp Ctr
New York, New York, 10029
Columbia Presbyterian Med Ctr
New York, New York, 10032
Harlem Hosp Ctr
New York, New York, 10037
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
Arnold Palmer Hosp for Children & Women
Orlando, Florida, 32806
Sacred Heart Children's Hosp / CMS of Florida
Pensacola, Florida, 32503
Phoenix Childrens Hosp
Phoenix, Arizona, 85006
Med College of Virginia
Richmond, Virginia, 23219
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
Univ of Rochester Med Ctr
Rochester, New York, 146420001
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
Washington Univ School of Medicine
St Louis, Missouri, 63110
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
Univ of South Florida
Tampa, Florida, 33606
Bronx Lebanon Hosp Ctr
The Bronx, New York, 10457
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
Puerto Rico6 sites
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 00956
Caguas Regional Hosp
Caguas, 00726
Mayguez Med Ctr / Regional Immunology Clinic
Mayguez, 00680
Ponce Univ Hosp
Ponce, 00731
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067
San Juan City Hosp
San Juan, 009367344
Brazil3 sites
Federal University of Minas, Dept. of Pediatrics
Belo Horizonte-MG
Hosp dos Servidores do Estado
Rio de Janeiro
Hosp Univ Clementino Fraga Filho
Rio de Janeiro RJ
The Bahamas1 site
Princess Margaret Hosp
Nassau
About this study
Official title: A Randomized, Double-Blind, Controlled Study of an Increased Caloric Density Infant Formula and Its Effect on Growth and Nutritional Status in HIV-Infected Infants
This study examines the effects of an infant formula containing increased calories, as compared to commercial formulas, when given during the first 6 months of life. It will examine effects on growth, disease progress, immune system, and quality of life of infected infants.
HIV disease in infants often leads to nutritional deficiencies. Providing increased nutrition early in their lives may help the quality of life of children who contract HIV from their mothers.
Read the detailed description
In order to meet the optimal nutritional needs of HIV-infected infants, it is critical that nutritional intervention begin early. Early nutritional intervention may help reduce the susceptibility to or severity of primary HIV and/or opportunistic infections and add to the quality of life for children perinatally infected with HIV.
[AS PER AMENDMENT 08/29/01: This study population will consist of infants from domestic sites and international sites.] In this double-blind, controlled study perinatally HIV-exposed infants less than 15 days old [AS PER AMENDMENT 08/29/01: "less than 15 days old" has been replaced with: less than 17 days old] at time of study entry are randomized to 1 of 2 arms to receive either concentrated formula or standard formula for 8 weeks after being stratified by gestational age: less than 37 versus greater than 37 completed weeks. At the 8-week visit using a previously determined 8:1 random allocation, 89% of singleton infants [AS PER AMENDMENT 08/29/01: from international sites] with negative HIV-specific tests are discontinued from study treatment and further follow-up. The other 11 percent of these singleton infants with negative HIV-specific tests continue study treatment with open-label standard formula until Week 28 (control group). Singleton infants with positive HIV-specific tests continue on the blinded portion of the study and receive formula as initially assigned until Week 28. For a given multiple birth, if any of the infants at the 8-week study visit are determined to be infected, all the infants from that birth continue their initial blinded treatment assignment until Week 28; if none of the infants are determined to be infected at this time, all the infants from that birth continue study treatment with open-label standard formula until Week 28. All infants assigned to receive study treatment through Week 28 continue study follow-up until 12 months of age. A subset of patients at sites with appropriate resources will participate in a substudy in which measurements of triceps and thigh skinfold thickness and circumference and thigh density DEXA scans are evaluated.
- Conditions
- HIV Infections
- Being tested
- Infant Formula
- Keywords
- Nutritional Status, HIV Seronegativity, Infant Food
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaDrug
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 completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Enrolment
- 2,400 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Harland S Winter, Study chairJames Oleske, Study chairRoss McKinney, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000873
- Sponsor's protocol ID
- ACTG 247
- Other IDs
- PACTG 247, ACTG 844 Substudy, 11224
- Status last verified
- Oct 2013
- First submitted
- 2 Nov 1999
- Last updated
- 7 Oct 2013
- Results posted
- No
Publications
Kaiser M, Hagopian J, Ernestine J, Moye J, Fowler M, Nesel C. Providing access to HIV-research opportunities for disenfranchised populations. Int Conf AIDS. 1998;12:845-6 (abstract no 42358)
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Controlled Study of an Increased Caloric Density Infant Formula and Its Effect on Growth and Nutritional Status in HIV-Infected Infants
- ClinicalTrials.gov ID
- NCT00000873
- Acronym / sponsor ID
- ACTG 247
- Conditions
- HIV Infections
- Keywords
- Nutritional Status, HIV Seronegativity, Infant Food
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study completion
- Sep 2005 (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.
This study examines the effects of an infant formula containing increased calories, as compared to commercial formulas, when given during the first 6 months of life. It will examine effects on growth, disease progress, immune system, and quality of life of infected infants.
HIV disease in infants often leads to nutritional deficiencies. Providing increased nutrition early in their lives may help the quality of life of children who contract HIV from their mothers.
Detailed description
In order to meet the optimal nutritional needs of HIV-infected infants, it is critical that nutritional intervention begin early. Early nutritional intervention may help reduce the susceptibility to or severity of primary HIV and/or opportunistic infections and add to the quality of life for children perinatally infected with HIV.
[AS PER AMENDMENT 08/29/01: This study population will consist of infants from domestic sites and international sites.] In this double-blind, controlled study perinatally HIV-exposed infants less than 15 days old [AS PER AMENDMENT 08/29/01: "less than 15 days old" has been replaced with: less than 17 days old] at time of study entry are randomized to 1 of 2 arms to receive either concentrated formula or standard formula for 8 weeks after being stratified by gestational age: less than 37 versus greater than 37 completed weeks. At the 8-week visit using a previously determined 8:1 random allocation, 89% of singleton infants [AS PER AMENDMENT 08/29/01: from international sites] with negative HIV-specific tests are discontinued from study treatment and further follow-up. The other 11 percent of these singleton infants with negative HIV-specific tests continue study treatment with open-label standard formula until Week 28 (control group). Singleton infants with positive HIV-specific tests continue on the blinded portion of the study and receive formula as initially assigned until Week 28. For a given multiple birth, if any of the infants at the 8-week study visit are determined to be infected, all the infants from that birth continue their initial blinded treatment assignment until Week 28; if none of the infants are determined to be infected at this time, all the infants from that birth continue study treatment with open-label standard formula until Week 28. All infants assigned to receive study treatment through Week 28 continue study follow-up until 12 months of age. A subset of patients at sites with appropriate resources will participate in a substudy in which measurements of triceps and thigh skinfold thickness and circumference and thigh density DEXA scans are evaluated.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 1 day to 17 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Are 1 to 17 days old. (This study has been changed. Originally, infants 1 to 15 days old were eligible for this study.)
- Weigh 4 or more pounds.
- Were born to an HIV-positive mother.
- Have a caregiver willing to measure and keep records of infant's food intake.
Key exclusion criteria (4 listed)
- Are breast-fed.
- Have certain disorders, including the inability to feed by mouth, or a life-threatening condition.
- Take medication which affects growth.
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 |
|---|---|---|
| Infant Formula | 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 7 Oct 2013.
- BackgroundKaiser M, Hagopian J, Ernestine J, Moye J, Fowler M, Nesel C. Providing access to HIV-research opportunities for disenfranchised populations. Int Conf AIDS. 1998;12:845-6 (abstract no 42358)
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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.
Harland S Winter study chair
James Oleske study chair
Ross McKinney study chair
72 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 72 sites in 4 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 5 inclusion and 4 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 7 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 72 sites in United States, Puerto Rico, Brazil, The Bahamas. 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 NCT00000873, which also lists 1 linked publication.
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 7 Oct 2013.