HIV InfectionsPhase 1NCT00002365
A Study of LXR015-1 in HIV-Infected Patients
A Phase 1 study testing LXR015-1 in people with HIV Infections, run by LXR Biotechnology at 1 site in United States.
Trial summary
To determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- LXR015-1
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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
- Patients must have:
- Documented HIV infection.
- CD4 cell count less than 200 cells/mm3.
- Prior Medication:
- Allowed:
- Acute therapy for opportunistic infections or serious AIDS defining infections must be completed at least 28 days before study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Patients that are unable to take adequate oral intake (i.e. unable to eat 1 or more meals a day because of chronic nausea, emesis, or abdominal/oral/esophageal discomfort).
- Patients who have severe diarrhea as defined as >= 7 stools per day, or acute diarrhea due to a treatable cause.
- NOTE:
- If the patient has Cryptosporidia, Mycobacterium avium, or Cytomegalovirus that is unresponsive to treatment and has less than 7 stools per day, the patient may participate in this study.
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- Patients who have any severe or life-threatening laboratory or clinical abnormality, or are not expected to live for 8 weeks.
- Patients who have an active opportunistic infection, including tuberculosis, cryptococcosis, or other serious AIDS defining infections requiring immediate treatment. Acute therapy must be completed at least 28 days before study entry.
- Patients with unexplained elevated temperature >= 38.5 degrees C that persists for 7 days or more within 14 days before study entry.
- Patients with malignancy other than squamous or basal carcinomas of the skin. Patients with visceral Kaposi's sarcoma or lymphoma requiring systemic chemotherapy or radiation treatment will be excluded. Patients with Kaposi's of the skin or mucous membranes may enroll in this study.
- Patients, who in the judgment of the investigator are unable to comply with the protocol.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following prior condition are excluded:
- A known history of hypersensitivity reaction to soy protein or soy lecithin. NOTE:
- This hypersensitivity is identified through medical history, not skin testing.
- Excluded:
- Systemic chemotherapy.
- Acute therapy for opportunistic infections or other serious AIDS defining infections.
- Intravenous rehydration as treatment for diarrhea.
- Required:
- Patient must be taking a stable regimen (about 8 weeks) of anti-viral, anti-opportunistic infection and/or anti-diarrheal (if patient has diarrhea) medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel, Open-Label Phase I Study of LXR015-1 in HIV-Infected Patients
To determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected patients.
Read the detailed description
Patients will be randomized to 1 of 3 doses of oral LXR015-1 for 28 days and patients will be monitored for adverse events for the duration of the study. Patients will continue to be monitored for least 4 weeks after completion of the dosing.
- Conditions
- HIV Infections
- Being tested
- LXR015-1
- Keywords
- Dose-Response Relationship, Drug, Administration, Oral, Acquired Immunodeficiency Syndrome, Anti-HIV Agents
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LXR015-1Drug
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.
- 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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- LXR Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bathurst I, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002365
- Sponsor's protocol ID
- 258A
- Status last verified
- Jul 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel, Open-Label Phase I Study of LXR015-1 in HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00002365
- Acronym / sponsor ID
- 258A
- Conditions
- HIV Infections
- Keywords
- Dose-Response Relationship, Drug, Administration, Oral, Acquired Immunodeficiency Syndrome, Anti-HIV Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- LXR BiotechnologyIndustry (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 determine and compare the safety and tolerability of 3 doses of LXR015-1 in HIV-infected patients.
Detailed description
Patients will be randomized to 1 of 3 doses of oral LXR015-1 for 28 days and patients will be monitored for adverse events for the duration of the study. Patients will continue to be monitored for least 4 weeks after completion of the dosing.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented HIV infection.
- CD4 cell count less than 200 cells/mm3.
- Acute therapy for opportunistic infections or serious AIDS defining infections must be completed at least 28 days before study entry.
Key exclusion criteria (23 listed)
- Patients that are unable to take adequate oral intake (i.e. unable to eat 1 or more meals a day because of chronic nausea, emesis, or abdominal/oral/esophageal discomfort).
- Patients who have severe diarrhea as defined as >= 7 stools per day, or acute diarrhea due to a treatable cause.
- If the patient has Cryptosporidia, Mycobacterium avium, or Cytomegalovirus that is unresponsive to treatment and has less than 7 stools per day, the patient may participate in this study.
- Patients who have any severe or life-threatening laboratory or clinical abnormality, or are not expected to live for 8 weeks.
- Patients who have an active opportunistic infection, including tuberculosis, cryptococcosis, or other serious AIDS defining infections requiring immediate treatment. Acute therapy must be completed at least 28 days before study entry.
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 |
|---|---|---|
| LXR015-1 | 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 24 Jun 2005.
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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.
Bathurst I study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LXR015-1 in people with HIV Infections, run by LXR Biotechnology at 1 site 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 23 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 24 Jun 2005.