HIV InfectionsNCT00002392
A Study of Thalidomide in HIV-Infected Patients Who Are Receiving HAART
A study testing Thalidomide in people with HIV Infections, run by Rockefeller University at 1 site in United States.
Trial summary
To ascertain the effect of thalidomide on immune responses to vaccination with polyvalent pneumococcal polysaccharide vaccine and tetanus toxoid in HIV-infected patients; particularly, on markers of immune activation and parameters of specific, anti-HIV cellular immunity. 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
- 12 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:
- Documented HIV infection.
- CD4+ cell count between 300 and 500 cells/mm3.
- HIV-1 RNA < 500 by the branched-chain DNA assay (bDNA assay, Chiron) within 21 days of study entry [AS PER AMENDMENT 11/25/98:
- Undetectable-plasma HIV titers (as defined by the FDA) by the branched-chain DNA test].
- Established B cell lines [deleted AS PER AMENDMENT 11/25/98].
- Response to at least one recall antigen in an in vitro assay of lymphocyte proliferative responses.
- Life expectancy > 6 months [deleted AS PER AMENDMENT 11/25/98].
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Active opportunistic infection or HIV-related malignancy [HIV-related malignancy deleted AS PER AMENDMENT 11/25/98].
- Peripheral neuropathy of grade 2 or higher by Division of AIDS toxicity criteria.
- Concurrent Medication:
- Excluded:
Show all 22Show fewer
- Other investigational HIV-drugs.
- Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline.
- Patients with the following prior conditions are excluded:
- History of serious hypersensitivity to tetanus toxoid or any of the vaccine components.
- Prior Medication:
- Excluded:
- Previous immunization with pneumococcal polysaccharide vaccine [or, AS PER AMENDMENT 11/25/98, keyhole limpet hemocyanin vaccine].
- Tetanus toxoid booster within 5 years [deleted AS PER AMENDMENT 11/25/98].
- Other investigational HIV-drugs within 6 weeks of enrollment.
- Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline within 6 weeks of enrollment.
- Risk Behavior:
- Excluded:
- Active drug or alcohol abuse.
- Required:
- Effective combination antiretroviral therapy including two nucleoside analog agents (ZDV, 3TC, ddI, ddC, or d4T) and nelfinavir or indinavir, for at least one month prior to study entry. [AS PER AMENDMENT 11/25/98:
- On stable, effective, highly-active antiretroviral therapy with combinations of any FDA-approved anti-HIV drugs for at least 3 months prior to entry.]
Trial locations and contacts
1 site in 1 country.
United States1 site
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, 10021
About this study
Official title: A Study to Investigate the Potential of Thalidomide Treatment to Enhance Immune Responses in HIV-Infected Individuals Who Are Receiving Highly Active Antiretroviral Therapy.
To ascertain the effect of thalidomide on immune responses to vaccination with polyvalent pneumococcal polysaccharide vaccine and tetanus toxoid in HIV-infected patients; particularly, on markers of immune activation and parameters of specific, anti-HIV cellular immunity.
Read the detailed description
Patients receive oral thalidomide in a blinded, placebo-controlled study. [AS PER AMENDMENT 11/25/98: This is a double-blind, placebo-controlled trial in which thalidomide or placebo is administered for 21 days. After the first week of therapy, patients receive immunizations with keyhole limpet hemocyanin and polyvalent pneumococcal vaccine. Study therapy is stopped for 2 weeks after the immunizations. Following the immunizations, detailed evaluations of the immune responses to the vaccines are conducted over the next 8 weeks.]
- Conditions
- HIV Infections
- Being tested
- Thalidomide
- Keywords
- Lymphocyte Transformation, Immunity, Cellular, Drug Therapy, Combination, Adjuvants, Immunologic, Thalidomide, Immunologic Memory, Streptococcus pneumoniae, Tetanus Toxoid, Pneumococcal Vaccines
- Medical subject headings
- HIV Infections, Tetanus
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
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002392
- Sponsor's protocol ID
- 279A
- Status last verified
- Apr 1999
- 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 Study to Investigate the Potential of Thalidomide Treatment to Enhance Immune Responses in HIV-Infected Individuals Who Are Receiving Highly Active Antiretroviral Therapy.
- ClinicalTrials.gov ID
- NCT00002392
- Acronym / sponsor ID
- 279A
- Conditions
- HIV Infections
- Keywords
- Lymphocyte Transformation, Immunity, Cellular, Drug Therapy, Combination, Adjuvants, Immunologic, Thalidomide, Immunologic Memory, Streptococcus pneumoniae, Tetanus Toxoid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- Rockefeller UniversityUniversity, 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 ascertain the effect of thalidomide on immune responses to vaccination with polyvalent pneumococcal polysaccharide vaccine and tetanus toxoid in HIV-infected patients; particularly, on markers of immune activation and parameters of specific, anti-HIV cellular immunity.
Detailed description
Patients receive oral thalidomide in a blinded, placebo-controlled study. [AS PER AMENDMENT 11/25/98: This is a double-blind, placebo-controlled trial in which thalidomide or placebo is administered for 21 days. After the first week of therapy, patients receive immunizations with keyhole limpet hemocyanin and polyvalent pneumococcal vaccine. Study therapy is stopped for 2 weeks after the immunizations. Following the immunizations, detailed evaluations of the immune responses to the vaccines are conducted over the next 8 weeks.]
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documented HIV infection.
- CD4+ cell count between 300 and 500 cells/mm3.
- HIV-1 RNA < 500 by the branched-chain DNA assay (bDNA assay, Chiron) within 21 days of study entry [AS PER AMENDMENT 11/25/98:
- Undetectable-plasma HIV titers (as defined by the FDA) by the branched-chain DNA test].
- Established B cell lines [deleted AS PER AMENDMENT 11/25/98].
Key exclusion criteria (22 listed)
- Active opportunistic infection or HIV-related malignancy [HIV-related malignancy deleted AS PER AMENDMENT 11/25/98].
- Peripheral neuropathy of grade 2 or higher by Division of AIDS toxicity criteria.
- Other investigational HIV-drugs.
- Immunomodulatory or potentially immunomodulatory drugs, such as glucocorticoids, hematopoietins, interleukin-2, interferon, or pentoxifylline.
- History of serious hypersensitivity to tetanus toxoid or any of the vaccine components.
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.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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 Rockefeller University 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 8 inclusion and 22 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.