HIV InfectionsPhase 3NCT00002109
Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy
A Phase 3 study testing Thymopentin, Stavudine and Zidovudine in people with HIV Infections, run by Immunobiology Research Institute at 50 sites in 2 countries.
Trial summary
To confirm results from a previous study in which the combination of thymopentin plus zidovudine ( AZT ), an antiretroviral agent, slowed disease progression in HIV-infected asymptomatic 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?
- Thymopentin, Stavudine and Zidovudine
- How many people
- Not given
- Where
- 50 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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:
- Asymptomatic HIV infection.
- CD4 count 100-400 cells/mm3.
- No HIV-associated neurologic abnormalities or constitutional symptoms.
- No oral hairy leukoplakia.
- At least 6 months of prior AZT.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Abnormal chest x-ray, consistent with active opportunistic infection.
- Hypersensitivity to thymopentin.
- Significant chronic underlying medical illness.
- Grade 2 or worse peripheral neuropathy.
Show all 32Show fewer
- Concurrent Medication:
- Excluded:
- HIV vaccines.
- Investigational or non-FDA approved medication.
- Immunomodulatory therapies.
- Experimental therapies.
- Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC.
- Patients with the following prior conditions are excluded:
- Herpes zoster (within the past year).
- Recurrent (> one episode) oral candidiasis (confirmed).
- Vulvovaginal candidiasis (persistent, frequent, or poorly responsive to therapy).
- Bacillary angiomatosis.
- Listeriosis.
- Idiopathic thrombocytopenia purpura.
- Prior Medication:
- Excluded at any time prior to study entry:
- More than one dose of thymopentin.
- Excluded within 30 days prior to study entry:
- HIV vaccines.
- Investigational or non-FDA approved medication.
- Immunomodulatory therapies.
- Experimental therapies.
- Any antiretroviral therapy other than AZT, ddI, ddC, d4T, or 3TC.
- Required:
- Prior AZT (>= 300 mg/day) for at least 6 months; on current regimen (any combination of approved nucleoside analogues) for at least 4 weeks.
- Significant active alcohol or drug abuse.
Trial locations and contacts
50 sites in 2 countries.
50 sites in 2 countries
United States48 sites
Lovelace Scientific Resource
Albuquerque, New Mexico, 87108
West Paces Clinical Research Inc
Atlanta, Georgia, 30327
Central Texas Med Foundation
Austin, Texas, 78751
CRI of New England
Brookline, Massachusetts, 02445
Northwestern Univ Med Ctr
Chicago, Illinois, 60611
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Ctr for Special Immunology
Chicago, Illinois, 60657
Cleveland Clinic
Cleveland, Ohio, 44106
Community Research Initiative
Coral Gables, Florida, 33146
Dr Christopher McNulty
Dallas, Texas, 75219
Nelson-Tebedo Community Clinic
Dallas, Texas, 75219
Ctr for Special Immunology
Fort Lauderdale, Florida, 33316
Stratogen of Ft Lauderdale
Fort Lauderdale, Florida, 33334
Dr Gary Blick
Greenwich, Connecticut, 06830
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Houston Clinical Research Network
Houston, Texas, 77006
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, 46202
Ctr for Special Immunology
Irvine, California, 92718
Kansas City AIDS Research Consortium
Kansas City, Missouri, 641082792
Novum Inc
Kirkland, Washington, 98034
Beer Med Group
Los Angeles, California, 90036
Stratogen of South Florida
Miami Beach, Florida, 33140
Dr David DiPietro
New York, New York, 10001
Ctr for Special Immunology
New York, New York, 10010
Dr Howard A Grossman
New York, New York, 10014
Dr Patrick Hennessey
New York, New York, 10016
New York Hosp - Cornell Med Ctr
New York, New York, 10021
Gottlieb Med Group
Pasadena, California, 90112
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Graduate Hosp
Philadelphia, Pennsylvania, 19146
Fisher Med Group
Phoenix, Arizona, 85013
Novum Inc
Pittsburgh, Pennsylvania, 15206
Dr Joel Godbey
Portland, Oregon, 97232
AIDS Community Research Consortium
Redwood City, California, 94063
HIV Research Group
San Diego, California, 92102
Conant Med Group
San Francisco, California, 94115
Kaiser Permanente Med Ctr
San Francisco, California, 94115
Pacific Oaks Med Group
Sherman Oaks, California, 91403
Systemic Mycoses Pathogen Study Group / Wash Univ Sch of Med
St Louis, Missouri, 63108
SUNY / Health Sciences Ctr at Stony Brook
Stony Brook, New York, 117948153
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
Saint Joseph's Hosp / Infectious Disease Rsch Institute
Tampa, Florida, 33614
Van Etten Hosp / Bronx Municipal Hosp Ctr
The Bronx, New York, 10461
Harbor - UCLA Med Ctr
Torrance, California, 90502
Associates Med and Mental Health
Tulsa, Oklahoma, 741141325
Dr Larry Bruni
Washington D.C., District of Columbia, 20003
Novum Inc
Washington D.C., District of Columbia, 20037
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
Puerto Rico2 sites
Univ of Puerto Rico Med Sciences Campus
Rio Piedras, 00935
Initiativa Comunitaria de Investigacion
San Juan, 00902
About this study
Official title: Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT/ddI or AZT/ddC) Anti-Retroviral Therapy
To confirm results from a previous study in which the combination of thymopentin plus zidovudine ( AZT ), an antiretroviral agent, slowed disease progression in HIV-infected asymptomatic patients. To evaluate the efficacy and safety of thymopentin in HIV-infected asymptomatic patients receiving either monotherapy with AZT, didanosine ( ddI ), or stavudine ( d4T ), or combination antiretroviral therapy with AZT / ddI or AZT / zalcitabine ( ddC ).
- Conditions
- HIV Infections
- Being tested
- Thymopentin, Stavudine, Zidovudine, Zalcitabine, Didanosine
- Keywords
- Thymopentin, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymopentinDrug
StavudineDrug
ZidovudineDrug
ZalcitabineDrug
DidanosineDrug
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 3
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Immunobiology Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002109
- Sponsor's protocol ID
- 015H
- Other IDs
- 07.32.033-93
- Status last verified
- Mar 1996
- 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
- Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT/ddI or AZT/ddC) Anti-Retroviral Therapy
- ClinicalTrials.gov ID
- NCT00002109
- Acronym / sponsor ID
- 015H
- Conditions
- HIV Infections
- Keywords
- Thymopentin, Zalcitabine, Didanosine, Drug Therapy, Combination, Zidovudine, Stavudine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Immunobiology Research InstituteIndustry (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 confirm results from a previous study in which the combination of thymopentin plus zidovudine ( AZT ), an antiretroviral agent, slowed disease progression in HIV-infected asymptomatic patients. To evaluate the efficacy and safety of thymopentin in HIV-infected asymptomatic patients receiving either monotherapy with AZT, didanosine ( ddI ), or stavudine ( d4T ), or combination antiretroviral therapy with AZT / ddI or AZT / zalcitabine ( ddC ).
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 (6 listed)
- Asymptomatic HIV infection.
- CD4 count 100-400 cells/mm3.
- No HIV-associated neurologic abnormalities or constitutional symptoms.
- No oral hairy leukoplakia.
- At least 6 months of prior AZT.
Key exclusion criteria (32 listed)
- Abnormal chest x-ray, consistent with active opportunistic infection.
- Hypersensitivity to thymopentin.
- Significant chronic underlying medical illness.
- Grade 2 or worse peripheral neuropathy.
- HIV vaccines.
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 |
|---|---|---|
| Thymopentin | Drug | – |
| Stavudine | Drug | – |
| Zidovudine | Drug | – |
| Zalcitabine | Drug | – |
| Didanosine | 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.
50 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thymopentin, Stavudine and Zidovudine in people with HIV Infections, run by Immunobiology Research Institute at 50 sites in 2 countries.
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 32 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 50 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.