HIV InfectionsPhase 1NCT00000728
Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy
A Phase 1 study testing Zidovudine and Aldesleukin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
To evaluate the short-term effects of administering zidovudine ( AZT ) at the same time with increasing doses of aldesleukin ( interleukin-2; IL-2 ) in patients with persistent generalized lymphadenopathy syndrome ( PGL ). 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?
- Zidovudine and Aldesleukin
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Apr 1990
- 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
- Detectable HIV nucleic acid in patient peripheral blood mononuclear leukocytes (PBML's) by the gene amplification technique. A positive antibody to HIV confirmed by any federally licensed ELISA test kit.
- Concurrent Medication:
- Allowed:
- Medications without which there might be significant risk, such as seizures, loss of diabetic control or respiratory embarrassment.
- Necessary topical agents including topical acyclovir.
- Diuretics for significant fluid retention only.
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- Concurrent Treatment:
- Allowed:
- Blood transfusions for anemia if hematocrit falls below 25 percent.
Who cannot join
- Active drug or alcohol abuse.
- Co-existing Condition:
- Patients with the following will be excluded:
- Grade 1 impairment on two or more items in the ACTG Micro Neuro AIDS assessment.
- Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
- Major organ allograft.
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- Significant cardiac disease or central nervous system lesions.
- Patients with hemophilia should be evaluated and treated under the hemophilia protocol.
- Concurrent Medication:
- Excluded:
- Inderal or vasoactive hypertensive medication.
- Non-essential medications including pain medications.
- Excluded are:
- Patients with an opportunistic infection or malignancy fulfilling the definition of AIDS.
- Patients with AIDS related complex, defined as:
- 1. Weight loss in excess of 15 lbs. or 10 percent of body weight noted in a 2-year period prior to entry into the study. 2. Temperature greater than 38.5 degrees C with or without night sweats, persisting for more than 14 consecutive days or more than 15 days in a 30-day interval during a 2-year period prior to entry into the study. 3. Diarrhea defined as = or > 3 liquid stools per day, persisting for more than 30 days during a 2-year period prior to entry into the study without a definable cause. 4. Herpes zoster during the past 2 years. 5. Oral candidiasis or biopsy-proven hairy leukoplakia during the last 2 years. 6. Active substance abuse.
- Prior Medication:
- Excluded:
- Zidovudine (AZT).
- Excluded within 30 days of study entry:
- Antiretroviral agents.
- Biologic response modifiers.
- Corticosteroids.
- Excluded within 60 days of study entry:
- Ribavirin.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Univ School of Medicine
Stanford, California, 94305
About this study
To evaluate the short-term effects of administering zidovudine ( AZT ) at the same time with increasing doses of aldesleukin ( interleukin-2; IL-2 ) in patients with persistent generalized lymphadenopathy syndrome ( PGL ). The effects to be studied include safety or toxicity, how quickly the drugs are used in the body, effects on the immune system, effects on HIV, concentrations in body fluids, and how quickly the drugs are cleared by the kidneys. The trial will establish the maximum tolerated dose ( MTD ) and will be a pilot study to determine the dose that has the greatest effect in the immune system.
AZT has been shown to be effective in HIV-related disease. IL-2 has been shown to increase immune responses and correct immune problems caused by HIV in the test tube. IL-2 has also been effective in treating Kaposi's sarcoma in a number of patients. Because of the clinical activities of these two drugs and because their toxicities and mechanisms of action do not overlap, it may be beneficial to combine the two drugs with their antiviral and immune stimulatory effects.
Read the detailed description
AZT has been shown to be effective in HIV-related disease. IL-2 has been shown to increase immune responses and correct immune problems caused by HIV in the test tube. IL-2 has also been effective in treating Kaposi's sarcoma in a number of patients. Because of the clinical activities of these two drugs and because their toxicities and mechanisms of action do not overlap, it may be beneficial to combine the two drugs with their antiviral and immune stimulatory effects.
Patients enter the study in staggered groups of five. All patients receive AZT orally every 4 hours for 12 weeks. At the end of 8 weeks, the first group of five patients receive the lowest dosage of IL-2 on a daily basis while still receiving AZT. Toxicity and immunologic effects are measured at the beginning of AZT therapy and then every 2 weeks. Each succeeding group of five patients receives a higher dose of IL-2, while receiving AZT, until the MTD is reached. Those patients who have shown no toxicity as well as improved immune function while taking both drugs receive a 4-week follow-up course of IL-2 5 weeks after stopping AZT. In addition, five patients who have completed the AZT / IL-2 combined treatment without significant toxicity are re-treated with 12 weeks of AZT alone starting 8 weeks after completing the initial combined AZT / IL-2 portion of treatment. Another five patients will be re-treated with 12 weeks of full dose of AZT alone, followed by 8 weeks of half-dose AZT alone starting 8 weeks after completing the initial combined AZT / IL-2 treatment. Patients receive ibuprofen for fever and chills, and those who reach their MTD continue to receive that dose in combination with AZT for 4 weeks. If excess toxicity is observed on all doses of IL-2, the study will be discontinued.
- Conditions
- HIV Infections
- Being tested
- Zidovudine, Aldesleukin
- Keywords
- Immune Tolerance, Interleukin-2, Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, CD4-Positive T-Lymphocytes
- Medical subject headings
- HIV Infections, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZidovudineDrug
AldesleukinDrug
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)
- Study completionApr 1990
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.
- 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 1
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Merigan TC, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000728
- Sponsor's protocol ID
- ACTG 024
- Other IDs
- 11000
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 3 Nov 2021
- Results posted
- No
Publications
Schwartz DH, Skowron G, Merigan TC. Safety and effects of interleukin-2 plus zidovudine in asymptomatic individuals infected with human immunodeficiency virus. J Acquir Immune Defic Syndr (1988). 1991;4(1):11-23.
PubMed 1670586
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy
- ClinicalTrials.gov ID
- NCT00000728
- Acronym / sponsor ID
- ACTG 024
- Conditions
- HIV Infections
- Keywords
- Immune Tolerance, Interleukin-2, Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, CD4-Positive T-Lymphocytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Apr 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.
To evaluate the short-term effects of administering zidovudine ( AZT ) at the same time with increasing doses of aldesleukin ( interleukin-2; IL-2 ) in patients with persistent generalized lymphadenopathy syndrome ( PGL ). The effects to be studied include safety or toxicity, how quickly the drugs are used in the body, effects on the immune system, effects on HIV, concentrations in body fluids, and how quickly the drugs are cleared by the kidneys. The trial will establish the maximum tolerated dose ( MTD ) and will be a pilot study to determine the dose that has the greatest effect in the immune system.
AZT has been shown to be effective in HIV-related disease. IL-2 has been shown to increase immune responses and correct immune problems caused by HIV in the test tube. IL-2 has also been effective in treating Kaposi's sarcoma in a number of patients. Because of the clinical activities of these two drugs and because their toxicities and mechanisms of action do not overlap, it may be beneficial to combine the two drugs with their antiviral and immune stimulatory effects.
Detailed description
AZT has been shown to be effective in HIV-related disease. IL-2 has been shown to increase immune responses and correct immune problems caused by HIV in the test tube. IL-2 has also been effective in treating Kaposi's sarcoma in a number of patients. Because of the clinical activities of these two drugs and because their toxicities and mechanisms of action do not overlap, it may be beneficial to combine the two drugs with their antiviral and immune stimulatory effects.
Patients enter the study in staggered groups of five. All patients receive AZT orally every 4 hours for 12 weeks. At the end of 8 weeks, the first group of five patients receive the lowest dosage of IL-2 on a daily basis while still receiving AZT. Toxicity and immunologic effects are measured at the beginning of AZT therapy and then every 2 weeks. Each succeeding group of five patients receives a higher dose of IL-2, while receiving AZT, until the MTD is reached. Those patients who have shown no toxicity as well as improved immune function while taking both drugs receive a 4-week follow-up course of IL-2 5 weeks after stopping AZT. In addition, five patients who have completed the AZT / IL-2 combined treatment without significant toxicity are re-treated with 12 weeks of AZT alone starting 8 weeks after completing the initial combined AZT / IL-2 portion of treatment. Another five patients will be re-treated with 12 weeks of full dose of AZT alone, followed by 8 weeks of half-dose AZT alone starting 8 weeks after completing the initial combined AZT / IL-2 treatment. Patients receive ibuprofen for fever and chills, and those who reach their MTD continue to receive that dose in combination with AZT for 4 weeks. If excess toxicity is observed on all doses of IL-2, the study will be discontinued.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Detectable HIV nucleic acid in patient peripheral blood mononuclear leukocytes (PBML's) by the gene amplification technique. A positive antibody to HIV confirmed by any federally licensed ELISA test kit.
- Medications without which there might be significant risk, such as seizures, loss of diabetic control or respiratory embarrassment.
- Necessary topical agents including topical acyclovir.
- Diuretics for significant fluid retention only.
- Blood transfusions for anemia if hematocrit falls below 25 percent.
Key exclusion criteria (25 listed)
- Active drug or alcohol abuse.
- Grade 1 impairment on two or more items in the ACTG Micro Neuro AIDS assessment.
- Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
- Major organ allograft.
- Significant cardiac disease or central nervous system lesions.
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 |
|---|---|---|
| Zidovudine | Drug | – |
| Aldesleukin | 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 3 Nov 2021.
- Background: PubMed 1670586Schwartz DH, Skowron G, Merigan TC. Safety and effects of interleukin-2 plus zidovudine in asymptomatic individuals infected with human immunodeficiency virus. J Acquir Immune Defic Syndr (1988). 1991;4(1):11-23.
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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.
Merigan TC study chair
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 Zidovudine and Aldesleukin in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 9 inclusion and 25 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 3 Nov 2021. 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 NCT00000728, 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 3 Nov 2021.