HIV InfectionsNCT00002174
Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients
A study testing Thalidomide in people with HIV Infections, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
To determine if Thalidomide modulates the production of HIV-suppressor factors (MIP-1 alpha, MIP-1 beta, Rantes) and TH1 type cytokines (IL-12 and INF-gamma) in HIV-infected patients and alters viral load. 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?
- Thalidomide
- How many people
- 20 participants
- Where
- 1 siteUnited 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have:
- HIV infection.
- CD4+ cell count >= 200/microliter or > 14% CD4+ cells in peripheral blood.
- Willingness to commit to the study duration and agree to abide to the time table for entry into the study, ingestion of thalidomide and follow-up.
Who cannot join
- Co-existing Condition:
- Patients with any of the following conditions or symptoms are excluded:
- Fertile females.
- Patients who participated in a clinical study involving a new drug or device within the last 2 months or the period of time equivalent to seven times the half life of the study drug, whichever is longer.
- Patients with any of the following prior conditions are excluded:
- HIV related pre-existing peripheral neuropathy.
Show all 11Show fewer
- Prior Medication:
- Excluded:
- Patients using systemic steroidal anti inflammatory drugs or pentoxifylline within 10 days of dosing with thalidomide.
- Required:
- 10 of the 20 patients must be on antiretroviral therapy and the other 10 will be subjects who have decided not to be on any antiretroviral drug prior to enrollment into this study and do not plan to start such treatment during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
To determine if Thalidomide modulates the production of HIV-suppressor factors (MIP-1 alpha, MIP-1 beta, Rantes) and TH1 type cytokines (IL-12 and INF-gamma) in HIV-infected patients and alters viral load.
Read the detailed description
Patients will be divided, 5 per group, into Groups I, II, III and IV. Groups I and II will include patients who have decided not to take anti-retro viral drugs. Groups III and IV will include patients receiving the same types of antiretroviral drugs. Patients in groups I and III will receive thalidomide while patients in group II and IV will receive placebo. The placebo capsules will be the same color as the thalidomide capsules and will contain glucose powder. Patients will ingest one capsule of thalidomide at 9 PM daily on days 0, 1, 2, 3, 4, 5 and 6.
- Conditions
- HIV Infections
- Being tested
- Thalidomide
- Keywords
- Adjuvants, Immunologic, Thalidomide, Cytokines, Viral Load
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
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 N/A
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002174
- Sponsor's protocol ID
- 262A
- Status last verified
- Jul 1997
- 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
- Further Evaluation of Thalidomide's Ability to Potentiate the Immune Response to HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00002174
- Acronym / sponsor ID
- 262A
- Conditions
- HIV Infections
- Keywords
- Adjuvants, Immunologic, Thalidomide, Cytokines, Viral Load
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- 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 if Thalidomide modulates the production of HIV-suppressor factors (MIP-1 alpha, MIP-1 beta, Rantes) and TH1 type cytokines (IL-12 and INF-gamma) in HIV-infected patients and alters viral load.
Detailed description
Patients will be divided, 5 per group, into Groups I, II, III and IV. Groups I and II will include patients who have decided not to take anti-retro viral drugs. Groups III and IV will include patients receiving the same types of antiretroviral drugs. Patients in groups I and III will receive thalidomide while patients in group II and IV will receive placebo. The placebo capsules will be the same color as the thalidomide capsules and will contain glucose powder. Patients will ingest one capsule of thalidomide at 9 PM daily on days 0, 1, 2, 3, 4, 5 and 6.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV infection.
- CD4+ cell count >= 200/microliter or > 14% CD4+ cells in peripheral blood.
- Willingness to commit to the study duration and agree to abide to the time table for entry into the study, ingestion of thalidomide and follow-up.
Key exclusion criteria (11 listed)
- Fertile females.
- Patients who participated in a clinical study involving a new drug or device within the last 2 months or the period of time equivalent to seven times the half life of the study drug, whichever is longer.
- HIV related pre-existing peripheral neuropathy.
- Patients using systemic steroidal anti inflammatory drugs or pentoxifylline within 10 days of dosing with thalidomide.
- 10 of the 20 patients must be on antiretroviral therapy and the other 10 will be subjects who have decided not to be on any antiretroviral drug prior to enrollment into this study and do not plan to start such treatment during the study period.
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 |
|---|---|---|
| Thalidomide | 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thalidomide in people with HIV Infections, run by Louisiana State University Health Sciences Center in New Orleans 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 4 inclusion and 11 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.
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.