Immune Thrombocytopenic Purpura ( ITP )Phase 1NCT00002250
A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
A Phase 1 study testing CD4-IgG in people with Immune Thrombocytopenic Purpura ( ITP ) and HIV Infections, run by Genentech, Inc. at 1 site in United States.
Trial summary
To test the effectiveness of recombinant human CD4 Immunoglobulin G (CD4-IgG) in the treatment of HIV-associated immune thrombocytopenic purpura in patients with all levels of HIV infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenic Purpura ( ITP ), HIV Infections
- What is being tested?
- CD4-IgG
- How many people
- Not given
- 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
- Concurrent Medication:
- Allowed:
- Dapsone at a constant dose level and only as a prophylaxis for Pneumocystis carinii pneumonia (PCP).
- Zidovudine (AZT) at a constant dose for the 12 weeks of treatment, except if AZT-related toxicity is observed.
- Patients must have the following:
- HIV seropositive (asymptomatic, AIDS-related complex, or AIDS).
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- HIV-associated immune thrombocytopenic purpura.
- The ability to sign a written informed consent form, which must be obtained prior to treatment.
- A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.
- Patients currently on zidovudine are not excluded. However, the zidovudine dose level must remain constant for 4 weeks prior to entry and for the 12 weeks of treatment, except if zidovudine related toxicity is observed.
- A life expectancy of at least 3 months.
- Prior Medication:
- Allowed:
- Dapsone at a constant dose for more than 2 weeks prior to study entry.
- Zidovudine at a constant dose for 4 weeks prior to study entry.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions and symptoms are excluded:
- Active serious opportunistic infection (excluding positive block cultures of Mycobacterium avium complex or Cytomegalovirus).
- Malignancies other than Kaposi's sarcoma.
- Tumor-associated edema.
- Visceral Kaposi's sarcoma.
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- Significant neurologic, cardiac, or liver disease.
- Concurrent Medication:
- Excluded:
- Ganciclovir (DHPG). Pyrimethamine. Clindamycin. Sulfadiazine. Folinic acid. Prednisone. Intravenous gamma globulin. Intravenous acyclovir. Interferon. Systemic corticosteroids. Non-steroidal anti-inflammatory drugs (NSAIDs). Known immunomodulatory agents. Dideoxycytosine. Dideoxyinosine. Nucleoside analogs (with the exception of zidovudine or topical acyclovir). Any experimental therapy.
- Patients with the following are excluded:
- Active serious opportunistic infection (excluding positive block cultures of Mycobacterium avium complex or Cytomegalovirus).
- Malignancies other than Kaposi's sarcoma.
- Kaposi's sarcoma requiring therapy.
- Tumor-associated edema.
- Visceral Kaposi's sarcoma.
- Significant neurologic, cardiac, or liver disease.
- Conditions requiring excluded concomitant medications.
- Herpes virus infection requiring intravenous acyclovir.
- Prior Medication:
- Excluded for a minimum of 4 weeks prior to study entry:
- Chemotherapy.
- Immunomodulatory agents.
- Any experimental therapy.
- Prior Treatment:
- Excluded for a minimum of 4 weeks prior to study entry:
- Radiation therapy.
- Any experimental therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Gen Hosp
San Francisco, California, 941102859
About this study
To test the effectiveness of recombinant human CD4 Immunoglobulin G (CD4-IgG) in the treatment of HIV-associated immune thrombocytopenic purpura in patients with all levels of HIV infection.
- Being tested
- CD4-IgG
- Keywords
- Recombinant Proteins, IgG, Drug Evaluation, Antigens, CD4
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD4-IgGDrug
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 Immune Thrombocytopenic Purpura ( ITP )Studies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002250
- Sponsor's protocol ID
- 076A
- Other IDs
- D0177g
- Status last verified
- Aug 1991
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Kahn J, Hassner A, Arri C, Coleman R, Kaplan L, Volberding P, Ammann A, Abrams D. A phase 1 study of recombinant human CD4 immunoglobulin g (rCD4-IgG) in patients with HIV-associated immune thrombocytopenic purpura. Int Conf AIDS. 1991 Jun 16-21;7(2):221 (abstract no WB2156)
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 I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients With HIV-Associated Immune Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT00002250
- Acronym / sponsor ID
- 076A
- Keywords
- Recombinant Proteins, IgG, Drug Evaluation, Antigens, CD4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Genentech, Inc.Industry (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 test the effectiveness of recombinant human CD4 Immunoglobulin G (CD4-IgG) in the treatment of HIV-associated immune thrombocytopenic purpura in patients with all levels of HIV infection.
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 (15 listed)
- Dapsone at a constant dose level and only as a prophylaxis for Pneumocystis carinii pneumonia (PCP).
- Zidovudine (AZT) at a constant dose for the 12 weeks of treatment, except if AZT-related toxicity is observed.
- HIV seropositive (asymptomatic, AIDS-related complex, or AIDS).
- HIV-associated immune thrombocytopenic purpura.
- The ability to sign a written informed consent form, which must be obtained prior to treatment.
Key exclusion criteria (28 listed)
- Active serious opportunistic infection (excluding positive block cultures of Mycobacterium avium complex or Cytomegalovirus).
- Malignancies other than Kaposi's sarcoma.
- Tumor-associated edema.
- Visceral Kaposi's sarcoma.
- Significant neurologic, cardiac, or liver disease.
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 |
|---|---|---|
| CD4-IgG | 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.
- BackgroundKahn J, Hassner A, Arri C, Coleman R, Kaplan L, Volberding P, Ammann A, Abrams D. A phase 1 study of recombinant human CD4 immunoglobulin g (rCD4-IgG) in patients with HIV-associated immune thrombocytopenic purpura. Int Conf AIDS. 1991 Jun 16-21;7(2):221 (abstract no WB2156)
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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 Phase 1 study testing CD4-IgG in people with Immune Thrombocytopenic Purpura ( ITP ) and HIV Infections, run by Genentech, Inc. 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 15 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 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?
On the ClinicalTrials.gov record for NCT00002250, 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.