HIV InfectionsPhase 2NCT00002127
A Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
A Phase 2 study testing Thalidomide in people with HIV Infections and HIV Wasting Syndrome, run by Celgene Corporation at 13 sites in United States.
Trial summary
To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, HIV Wasting Syndrome
- What is being tested?
- Thalidomide
- How many people
- 75 participants
- Where
- 13 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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
- Concurrent Medication:
- Allowed:
- Primary prophylaxis for opportunistic infections (if AFB blood culture negative).
- Chronic suppressive therapy (maintenance) for opportunistic infections OTHER THAN Mycobacterium avium Complex (MAC).
- Patients must have:
- Documented HIV infection.
Show all 10Show fewer
- Wasting syndrome.
- Negative blood PCR for acid-fast bacteria (AFB) or a negative AFB blood culture within 48 days prior to study entry.
- No active opportunistic infection requiring systemic therapy within 6 weeks prior to study entry.
- Life expectancy of at least 6 weeks.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Chronic diarrhea (five or more unformed stools per day).
- Peripheral neuropathy of grade 2 or worse.
- Requirement for tube feeding or intravenous feeding.
- Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure).
Show all 28Show fewer
- Inability to ingest at least a maintenance diet based on present weight.
- Any condition that precludes study participation.
- Not under the care of a primary physician.
- Concurrent Medication:
- Excluded:
- Chronic suppressive therapy (maintenance) or secondary prophylaxis for Mycobacterium avium Complex (MAC) (suppressive therapy for other opportunistic infections is allowed).
- Concurrent Treatment:
- Excluded:
- Radiotherapy.
- Patients with the following prior conditions are excluded:
- Any neoplasms other than non-medicated (i.e., not receiving systemic or intralesional chemotherapy) Kaposi's sarcoma within 1 month prior to study entry.
- Prior intolerance to thalidomide.
- Prior Medication:
- Excluded:
- ddC within 1 month prior to study entry.
- Acute systemic therapy for opportunistic infections within 6 weeks prior to study entry.
- Agents that are anabolic, catabolic, or immunomodulatory (including interferons, megestrol, dronabinol, oxandrolone, growth hormone, systemic corticosteroids, and pentoxifylline) within 30 days prior to study entry.
- Prior Treatment:
- Excluded:
- Radiotherapy within 6 weeks prior to study entry.
- Required ONLY IF patient is on antiretroviral therapy:
- Stable regimen of AZT or ddI for at least 1 month prior to study entry. Active drug abuse within 3 months prior to study entry.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
Marin County Specialty Clinic
Greenbrae, California, 94904
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111
Rockefeller Univ
New York, New York, 10021
Saint Michael's Med Ctr
Newark, New Jersey, 07102
Thomas Jefferson Med College
Philadelphia, Pennsylvania, 19107
AIDS Community Research Consortium
Redwood City, California, 940631633
UCSD Med Ctr - Owen Clinic
San Diego, California, 921038681
San Francisco Gen Hosp
San Francisco, California, 94110
Kaiser Permanente Med Ctr
San Francisco, California, 94115
Advanced Research Management
Seattle, Washington, 981225314
Gottlieb Med Group
Sherman Oaks, California, 91403
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
About this study
To evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.
Read the detailed description
Patients are randomized to receive either thalidomide at 1 of 2 doses or placebo for 8 weeks. Patients who respond may continue in double-blinded treatment for an additional 4 weeks; nonresponding patients may receive thalidomide for up to 4 weeks. Per amendment, patients may receive thalidomide for more than 12 weeks on a compassionate basis.
- Conditions
- HIV Infections, HIV Wasting Syndrome
- Being tested
- Thalidomide
- Keywords
- Acquired Immunodeficiency Syndrome, Cachexia, Thalidomide
- Medical subject headings
- HIV Infections, HIV Wasting Syndrome, Acquired Immunodeficiency Syndrome, Cachexia
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.
- 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 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002127
- Sponsor's protocol ID
- 230A
- Other IDs
- W-001
- Status last verified
- Jul 1997
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Stirling D, Sherman M, Strauss S. Thalidomide. A surprising recovery. J Am Pharm Assoc (Wash). 1997 May-Jun;NS37(3):306-13.
PubMed 9170807
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 Phase II, Parallel Group, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Thalidomide in Reducing Weight Loss in Adults With HIV Wasting Syndrome
- ClinicalTrials.gov ID
- NCT00002127
- Acronym / sponsor ID
- 230A
- Conditions
- HIV Infections, HIV Wasting Syndrome
- Keywords
- Acquired Immunodeficiency Syndrome, Cachexia, Thalidomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Celgene CorporationIndustry (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 evaluate the safety, antiviral and anti-TNF-alpha activity, and preliminary efficacy of thalidomide in reducing weight loss in patients with HIV wasting syndrome.
Detailed description
Patients are randomized to receive either thalidomide at 1 of 2 doses or placebo for 8 weeks. Patients who respond may continue in double-blinded treatment for an additional 4 weeks; nonresponding patients may receive thalidomide for up to 4 weeks. Per amendment, patients may receive thalidomide for more than 12 weeks on a compassionate basis.
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 (10 listed)
- Primary prophylaxis for opportunistic infections (if AFB blood culture negative).
- Chronic suppressive therapy (maintenance) for opportunistic infections OTHER THAN Mycobacterium avium Complex (MAC).
- Documented HIV infection.
- Wasting syndrome.
- Negative blood PCR for acid-fast bacteria (AFB) or a negative AFB blood culture within 48 days prior to study entry.
Key exclusion criteria (28 listed)
- Chronic diarrhea (five or more unformed stools per day).
- Peripheral neuropathy of grade 2 or worse.
- Requirement for tube feeding or intravenous feeding.
- Any disorder associated with moderate to severe edema (e.g., cirrhosis, nephrosis, congestive heart failure).
- Inability to ingest at least a maintenance diet based on present weight.
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.
- Background: PubMed 9170807Stirling D, Sherman M, Strauss S. Thalidomide. A surprising recovery. J Am Pharm Assoc (Wash). 1997 May-Jun;NS37(3):306-13.
Related trials for HIV Infections
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
Not yet recruiting
Supporting Health and Empowerment Through Contingency Management and Affect Regulation
HIV Risk
RecruitingPhase 1
HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
Plasmablastic Lymphoma, HIV
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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thalidomide in people with HIV Infections and HIV Wasting Syndrome, run by Celgene Corporation at 13 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 10 inclusion and 28 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 13 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
On the ClinicalTrials.gov record for NCT00002127, 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 24 Jun 2005.