HIV InfectionsPhase 2NCT00000659
A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex (ARC)
A Phase 2 study testing CD4 Antigens and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
Part 1A: To find the dose of zidovudine (AZT) that causes less than a 50 percent drop in HIV-1 p24 antigen levels in patients with AIDS and advanced AIDS related complex (ARC); to determine the pharmacokinetics (blood levels) of rsCD4 administered in combination with AZT. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- CD4 Antigens and Zidovudine
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento Jul 1990
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Nystatin or clotrimazole for suppression of oral thrush.
- Aerosolized pentamidine as chemoprophylaxis for Pneumocystis carinii pneumonia (PCP).
- Trimethoprim / sulfamethoxazole (TMP / SMX) for patients who are clinically and hematologically stable on TMP / SMX PCP prophylaxis.
- Patients must have the following:
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- Diagnosis of AIDS or advanced AIDS related complex (ARC).
- CD4 cell count < 300 cells/mm3.
- Ability to understand and sign the consent form.
- Risk Behavior:
- Allowed:
- History of drug abuse with current abstinence or enrollment in a methadone treatment program.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Malignancies other than Kaposi's sarcoma.
- AIDS dementia which, in the opinion of the investigator, precludes patients from giving fully informed consent or from complying fully with the requirements of this protocol.
- Active infection with an opportunistic pathogen requiring ongoing therapy.
- Preexisting antibodies to rCD4.
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- Concurrent Medication:
- Excluded:
- Investigational drugs.
- Antiretroviral agents such as dextran sulfate or AL721.
- Cytotoxic chemotherapy.
- Concurrent Treatment:
- Excluded:
- Radiation therapy.
- Patients with the following are excluded:
- Malignancies other than Kaposi's sarcoma.
- AIDS dementia which, in the opinion of the investigator, precludes patients from giving fully informed consent or from complying fully with the requirements of this protocol.
- Active infection with an opportunistic pathogen requiring ongoing therapy.
- Preexisting antibodies to rCD4.
- Prior Medication:
- Excluded:
- Zidovudine (AZT) for longer than 30 days or prior treatment with AZT for < 30 days if discontinued for toxicity due to AZT.
- Excluded within 30 days of study entry:
- Immunomodulators.
- Previous participation in any group of another part of this study. For example, patients treated in Part 1A of this study may not reenter the study to be treated in Part 2.
- Chemotherapy.
- Prior Treatment:
- Excluded within 30 days of study entry:
- Radiation therapy.
- Active use of illicit drugs or abuse of alcohol at time of protocol entry.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
About this study
Part 1A: To find the dose of zidovudine (AZT) that causes less than a 50 percent drop in HIV-1 p24 antigen levels in patients with AIDS and advanced AIDS related complex (ARC); to determine the pharmacokinetics (blood levels) of rsCD4 administered in combination with AZT. Parts 1B and 2: To test for additive or synergistic activity between rsCD4 and AZT as judged by falls in HIV-1 p24 antigen levels; and to evaluate the safety of rsCD4 and AZT in patients with AIDS and advanced ARC.
AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without toxicity. The most clinically significant toxicity is dose related inhibition of bone marrow function. Furthermore, HIV-1 isolates from patients treated for more than 6 months with AZT have now been found which appear to have reduced sensitivity to AZT. The incidence of toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability to administer AZT long-term to patients with AIDS and advanced ARC. Recombinant soluble CD4 (rCD4) has shown antiretroviral effects and has been shown to be safe when given to AIDS and ARC patients either as a single agent or in combination with AZT.
Read the detailed description
AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without toxicity. The most clinically significant toxicity is dose related inhibition of bone marrow function. Furthermore, HIV-1 isolates from patients treated for more than 6 months with AZT have now been found which appear to have reduced sensitivity to AZT. The incidence of toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability to administer AZT long-term to patients with AIDS and advanced ARC. Recombinant soluble CD4 (rCD4) has shown antiretroviral effects and has been shown to be safe when given to AIDS and ARC patients either as a single agent or in combination with AZT.
Part 1A: Twenty p24+ patients with AIDS or advanced ARC are randomized to 4 dosing groups of 5 patients each. Patients are treated with AZT for 6 weeks at ranging doses to determine a minimally effective dose (MED). At the end of week 6, each patient is sequentially assigned to 1 of 5 groups of rCD4 / AZT combination treatment. The first 3 patients to complete treatment through week 6 are treated in group A, the next 3 patients in group B, and so on. The treatment period is 4 weeks. Each patient continues on his or her AZT dose as initially administered. The highest dose of AZT that produces less than a 50 percent drop in HIV-1 p24 antigen levels in at least 3 of 5 patients over 6 weeks will be the MED of AZT and will be known as the AZT MED. After the MED is determined, Part 1B begins. Part 1B: 20 patients are randomized to 2 different dosing groups: Group 5: AZT MED (weeks 1 to 8), then AZT MED plus rCD4 (weeks 9 to 16); Group 6: AZT MED plus rCD4 (weeks 1 to 8), then AZT MED (weeks 9 to 16). Part 2: Part 2 begins once accrual to Part 1B is completed. If fewer than 10 of 20 patients exhibit a drop of at least 50 percent in p24 antigen level after receiving AZT and rsCD4 combination treatment, entry to Part 2 will be interrupted and the study design will be reevaluated. In Part 2, 10 patients are randomly assigned to one of four groups. Patients within each group receive two 8 week treatment courses. These two treatment courses are 8 weeks with the AZT MED alone, and 8 weeks of treatment with the combination of the AZT MED plus rCD4.
- Conditions
- HIV Infections
- Being tested
- CD4 Antigens, Zidovudine
- Keywords
- Acquired Immunodeficiency Syndrome, Antigens, CD4, AIDS-Related Complex, Zidovudine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD4 AntigensDrug
ZidovudineDrug
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)
- Primary completionJul 1990
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.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Biogen
- Investigators
- RT Schooley, Study chairDD Ho, Study chairTC Merigan, Study chairL Laubenstein, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000659
- Sponsor's protocol ID
- ACTG 133
- Other IDs
- C89-013-P
- Status last verified
- Jul 1990
- First submitted
- 2 Nov 1999
- Last updated
- 14 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of rsCD4 and AZT in Patients With AIDS or Advanced AIDS Related Complex (ARC)
- ClinicalTrials.gov ID
- NCT00000659
- Acronym / sponsor ID
- ACTG 133
- Conditions
- HIV Infections
- Keywords
- Acquired Immunodeficiency Syndrome, Antigens, CD4, AIDS-Related Complex, Zidovudine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 80 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Biogen
- Primary completion
- Jul 1990 (actual)
- 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.
Part 1A: To find the dose of zidovudine (AZT) that causes less than a 50 percent drop in HIV-1 p24 antigen levels in patients with AIDS and advanced AIDS related complex (ARC); to determine the pharmacokinetics (blood levels) of rsCD4 administered in combination with AZT. Parts 1B and 2: To test for additive or synergistic activity between rsCD4 and AZT as judged by falls in HIV-1 p24 antigen levels; and to evaluate the safety of rsCD4 and AZT in patients with AIDS and advanced ARC.
AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without toxicity. The most clinically significant toxicity is dose related inhibition of bone marrow function. Furthermore, HIV-1 isolates from patients treated for more than 6 months with AZT have now been found which appear to have reduced sensitivity to AZT. The incidence of toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability to administer AZT long-term to patients with AIDS and advanced ARC. Recombinant soluble CD4 (rCD4) has shown antiretroviral effects and has been shown to be safe when given to AIDS and ARC patients either as a single agent or in combination with AZT.
Detailed description
AZT has been shown to be effective in the treatment of AIDS and advanced ARC but not without toxicity. The most clinically significant toxicity is dose related inhibition of bone marrow function. Furthermore, HIV-1 isolates from patients treated for more than 6 months with AZT have now been found which appear to have reduced sensitivity to AZT. The incidence of toxicity and occurrence of virus with reduced sensitivity to AZT may result in the inability to administer AZT long-term to patients with AIDS and advanced ARC. Recombinant soluble CD4 (rCD4) has shown antiretroviral effects and has been shown to be safe when given to AIDS and ARC patients either as a single agent or in combination with AZT.
Part 1A: Twenty p24+ patients with AIDS or advanced ARC are randomized to 4 dosing groups of 5 patients each. Patients are treated with AZT for 6 weeks at ranging doses to determine a minimally effective dose (MED). At the end of week 6, each patient is sequentially assigned to 1 of 5 groups of rCD4 / AZT combination treatment. The first 3 patients to complete treatment through week 6 are treated in group A, the next 3 patients in group B, and so on. The treatment period is 4 weeks. Each patient continues on his or her AZT dose as initially administered. The highest dose of AZT that produces less than a 50 percent drop in HIV-1 p24 antigen levels in at least 3 of 5 patients over 6 weeks will be the MED of AZT and will be known as the AZT MED. After the MED is determined, Part 1B begins. Part 1B: 20 patients are randomized to 2 different dosing groups: Group 5: AZT MED (weeks 1 to 8), then AZT MED plus rCD4 (weeks 9 to 16); Group 6: AZT MED plus rCD4 (weeks 1 to 8), then AZT MED (weeks 9 to 16). Part 2: Part 2 begins once accrual to Part 1B is completed. If fewer than 10 of 20 patients exhibit a drop of at least 50 percent in p24 antigen level after receiving AZT and rsCD4 combination treatment, entry to Part 2 will be interrupted and the study design will be reevaluated. In Part 2, 10 patients are randomly assigned to one of four groups. Patients within each group receive two 8 week treatment courses. These two treatment courses are 8 weeks with the AZT MED alone, and 8 weeks of treatment with the combination of the AZT MED plus rCD4.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Nystatin or clotrimazole for suppression of oral thrush.
- Aerosolized pentamidine as chemoprophylaxis for Pneumocystis carinii pneumonia (PCP).
- Trimethoprim / sulfamethoxazole (TMP / SMX) for patients who are clinically and hematologically stable on TMP / SMX PCP prophylaxis.
- Diagnosis of AIDS or advanced AIDS related complex (ARC).
- CD4 cell count < 300 cells/mm3.
Key exclusion criteria (30 listed)
- Malignancies other than Kaposi's sarcoma.
- AIDS dementia which, in the opinion of the investigator, precludes patients from giving fully informed consent or from complying fully with the requirements of this protocol.
- Active infection with an opportunistic pathogen requiring ongoing therapy.
- Preexisting antibodies to rCD4.
- Investigational drugs.
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 Antigens | Drug | – |
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2011.
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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.
RT Schooley study chair
DD Ho study chair
TC Merigan study chair
2 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 CD4 Antigens and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 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 12 inclusion and 30 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: stopped early, as of the sponsor's last update on 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early. Results are not available in the source record.
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 14 Mar 2011.