Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
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| ClinicalTrials.gov Identifier: NCT00000664 |
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Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: August 4, 2008
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To determine the safety of polyethylene glycolated IL-2 (PEG IL2) administered weekly or biweekly (per amendment) in a setting of oral zidovudine (AZT). To determine the effect of PEG IL2 in combination with AZT on parameters assessing the immune system as well as HIV virus and antibody titers. To evaluate a chronic dosing study phase offered to patients who complete the initial 25-week regimen.
Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication (reproduction and growth). A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections | Drug: Interleukin-2, Polyethylene Glycolated Drug: Zidovudine | Phase 1 |
Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication (reproduction and growth). A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone.
Four groups are studied for a period of at least 25 weeks. Patients are observed for a minimum of 6 hours after infusion of PEG IL2. The 4 groups of patients are: Group A - asymptomatic with T4 count > 400 cells/mm3 (7 patients); Group B - asymptomatic with T4 count between 200 and 400 cells/mm3 (7 patients); Group C - asymptomatic with T4 count < 200 cells/mm3 (5 patients); Group D - diagnosed as having AIDS related complex (ARC) or AIDS (7 patients). All patients receive AZT. After a minimum 2-week period of AZT, patients receive an infusion of PEG IL-2 at 3 consecutive weekly intervals, followed by a 3-week period of AZT alone. This cycle (3 weeks of AZT and PEG IL-2 followed by 3 weeks of AZT alone) is repeated a total of three times (for a total of 18 weeks) followed by 8 weeks of AZT alone.
PER AMENDMENT: Ten patients may qualify for one of two groups: Group 1 - T4 count 200 - 400 cells/mm3 and meet all criteria established for Group B of the original protocol; Group 2 - T4 count < 200 cells/mm3 and meet all criteria established for Groups C and D of original protocol. Patients will receive an amended schedule of PEG IL2 IV every other week for eight doses, with dose escalation every other week for eight weeks permitted only in Group 2 patients who failed to show a 20 percent rise in T4 count at week 9 and who suffered no CNS or other adverse events at the lower dose.
PER ADDITIONAL AMENDMENT: Up to 10 additional patients may be treated at each dose of PEG IL2 on the biweekly schedule. Patients who respond to treatment on the biweekly schedule are eligible for an additional 9 weeks at their current dose.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 26 participants |
| Intervention Model: | Parallel Assignment |
| Primary Purpose: | Treatment |
| Official Title: | Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals |
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Prophylactic pentamidine for Pneumocystis carinii pneumonia (PCP).
- Topical steroids.
Patients must:
- Be HIV positive. Fit one of the zidovudine use groups listed in Disease Status. Be able to give informed consent.
Allowed:
- Basal cell carcinoma of the skin, in situ carcinoma of the cervix, Kaposi's sarcoma.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Major organ allograft.
- Significant cardiac disease or central nervous system lesions.
- Known previous intolerance to zidovudine (AZT) at 500 mg/day.
- Active opportunistic infections. Score of > 0.5 on the ACTG AIDS dementia complex staging test. Any focal abnormality on neurologic exam.
Concurrent Medication:
Excluded:
- Chemotherapy, hormonal therapy, or other immunotherapy.
- Other investigational drugs, agents, or devices.
- Beta-blockers.
- Steroids other than topical.
- Antihypertensive medication other than diuretics.
Concurrent Treatment:
Excluded:
- Radiation therapy.
Patients with the following are excluded:
- History of seizures. Concurrent neoplasms not specifically allowed.
- Concomitant conditions listed in Exclusion Co-existing Conditions.
Prior Medication:
Excluded within 30 days prior to study entry:
- Anti-HIV medication other than zidovudine (AZT).
- Immunomodulators.
- Systemic steroids.
- Interferons.
- Interleukins.
- Other chemotherapy.
Prior Treatment:
Excluded within 30 days prior to study entry:
- Radiation therapy.
Excluded within 4 weeks prior to study entry:
- Groups B, C, D
- Transfusions.
Active substance abuse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000664
| United States, California | |
| Stanford Univ School of Medicine | |
| Stanford, California, United States, 94305 | |
| Study Chair: | TC Merigan | ||
| Study Chair: | J Korvick |
Publications:
| ClinicalTrials.gov Identifier: | NCT00000664 History of Changes |
| Other Study ID Numbers: |
ACTG 141 CS-PG89-36 FDA 70A |
| First Posted: | August 31, 2001 Key Record Dates |
| Last Update Posted: | August 4, 2008 |
| Last Verified: | December 1994 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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Polyethylene Glycols Interleukin-2 Drug Evaluation Zidovudine |
Additional relevant MeSH terms:
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HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine Interleukin-2 Antimetabolites Molecular Mechanisms of Pharmacological Action |
Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |