HIV InfectionsNCT00002029
Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent
A study testing Fat Emulsion 2% and Fat Emulsion 20% in people with HIV Infections, run by Abbott at 2 sites in United States.
Trial summary
To compare two lipid emulsions in the long-term parenteral alimentation of patients with AIDS in relation to: Clinical effectiveness. Effect on immunologic function. Effect on HIV load as measured by p24 antigen levels. Effect on relative HIV infectivity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Fat Emulsion 2% and Fat Emulsion 20%
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Zidovudine (AZT).
- All drugs used for the standard treatment of opportunistic infections.
- Other drugs used for the treatment of other AIDS conditions if they have been started more than 3 months prior to study entry.
- Patients must have:
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- Diagnosis of AIDS.
- Weight loss of > 10 percent premorbid body weight.
- Presenting diagnosis of either opportunistic infection or Kaposi's sarcoma.
- Require home total parenteral nutrition (TPN) for a period of approximately 3 months.
- Life expectancy = or > 90 days.
- Prior Medication:
- Allowed:
- Zidovudine (AZT).
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Life expectancy < 90 days.
- Biliary stasis.
- History of drug abuse.
- Patients with the following are excluded:
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- Life expectancy < 90 days.
- Biliary stasis.
- History of drug abuse.
- Prior Medication:
- Excluded within 3 months of study entry:
- Immunomodulators.
- Experimental antiviral DT. History of drug abuse.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018
Intracare Inc
Miami, Florida, 33126
About this study
To compare two lipid emulsions in the long-term parenteral alimentation of patients with AIDS in relation to: Clinical effectiveness. Effect on immunologic function. Effect on HIV load as measured by p24 antigen levels. Effect on relative HIV infectivity.
- Conditions
- HIV Infections
- Being tested
- Fat Emulsion 2%, Fat Emulsion 20%
- Keywords
- Weight Loss, Parenteral Nutrition, Total, AIDS-Related Opportunistic Infections, Liposyn, Acquired Immunodeficiency Syndrome
- Medical subject headings
- HIV Infections, Weight Loss, Hyperphagia, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat Emulsion 2%Drug
Fat Emulsion 20%Drug
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)
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.
- 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
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002029
- Sponsor's protocol ID
- 041A
- Status last verified
- Feb 2009
- First submitted
- 2 Nov 1999
- Last updated
- 20 Feb 2009
- Results posted
- No
Publications
Singer P, Rubinstein A, Askanazi J, Calvelli T, Lazarus T, Kirvela O, Katz DP. Clinical and immunologic effects of lipid-based parenteral nutrition in AIDS. JPEN J Parenter Enteral Nutr. 1992 Mar-Apr;16(2):165-7. doi: 10.1177/0148607192016002165.
PubMed 1556814
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Nutritional Support in Patients With the Acquired Immunodeficiency Syndrome: Comparison of Liposyn III 2 Percent With Liposyn II 20 Percent
- ClinicalTrials.gov ID
- NCT00002029
- Acronym / sponsor ID
- 041A
- Conditions
- HIV Infections
- Keywords
- Weight Loss, Parenteral Nutrition, Total, AIDS-Related Opportunistic Infections, Liposyn, Acquired Immunodeficiency Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- 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 two lipid emulsions in the long-term parenteral alimentation of patients with AIDS in relation to: Clinical effectiveness. Effect on immunologic function. Effect on HIV load as measured by p24 antigen levels. Effect on relative HIV infectivity.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Zidovudine (AZT).
- All drugs used for the standard treatment of opportunistic infections.
- Other drugs used for the treatment of other AIDS conditions if they have been started more than 3 months prior to study entry.
- Diagnosis of AIDS.
- Weight loss of > 10 percent premorbid body weight.
Key exclusion criteria (13 listed)
- Life expectancy < 90 days.
- Biliary stasis.
- History of drug abuse.
- Life expectancy < 90 days.
- Biliary stasis.
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 |
|---|---|---|
| Fat Emulsion 2% | Drug | – |
| Fat Emulsion 20% | 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 20 Feb 2009.
- Background: PubMed 1556814Singer P, Rubinstein A, Askanazi J, Calvelli T, Lazarus T, Kirvela O, Katz DP. Clinical and immunologic effects of lipid-based parenteral nutrition in AIDS. JPEN J Parenter Enteral Nutr. 1992 Mar-Apr;16(2):165-7. doi: 10.1177/0148607192016002165.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat Emulsion 2% and Fat Emulsion 20% in people with HIV Infections, run by Abbott at 2 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 14 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 20 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 NCT00002029, 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 20 Feb 2009.