Effectiveness of Zidovudine vs. Zidovudine Plus Alpha Interferon vs. Interferon for Treatment of HIV
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This study will compare the effectiveness of zidovudine (AZT) alone vs. zidovudine plus interferon (IFN) vs. interferon alone in reducing HIV viral load, lessening immune system deterioration, and increasing the time to development of the first opportunistic infection in HIV-infected patients.
HIV-infected persons 18 years of age and older with a T4 lymphocyte count of 500/mm3 or more and no current opportunistic infections may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests, chest X-ray, electrocardiogram, urinalysis, and, for patients with Kaposi's sarcoma lesions, measurement, photographs, and biopsy of lesions.
Patients will be assigned to receive treatment with either zidovudine alone, zidovudine plus interferon or interferon alone. They will continue treatment until one of the following occurs:
- Unacceptable side effects, despite dose modifications
- Development of an opportunistic infection
- Decrease in CD4 count by 20 percent or to an absolute count of less than 200/mm3
- Rapid progression of Kaposi's sarcoma lesions, requiring alternative therapy
- A decision is made to terminate the study
Patients will be followed long term for viral load, immune function, development of opportunistic infections, disease progression, and survival.
Condition | Intervention | Phase |
---|---|---|
HIV Infection |
Drug: Ziodovudine and Alpha Interferon |
Phase 3 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | A Phase III Study With Long-Term Follow-Up of Zidovudine Versus Zidovudine and Alpha-Interferon Versus Alpha-Interferon in Patients With Early HIV Infection |
- Evaluate the relative efficacy of zidovudine (AZT) vs. AZT + alpha interferon (IFN) vs. IFN in increasing time to first opportunistic infection, reducing HIV viremia, and lessening immune system deterioration in HIV-infected persons.
- Patient will remain in long-term follow-up to provide information about the long-term outcomes of receiving anti-HIV treatment, and to provide information on long-term consequences of therapy analogous to a longitudinal natural history study.
Enrollment: | 180 |
Study Start Date: | September 1988 |
Estimated Study Completion Date: | December 2025 |
Estimated Primary Completion Date: | December 2025 (Final data collection date for primary outcome measure) |
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Drug: Ziodovudine and Alpha Interferon
Initial Study: Three Arm (Interventional) Study
This phase III study will evaluate the relative efficacy of zidovudine (AZT) vs. AZT + alpha interferon (IFN) vs. IFN in increasing time to first opportunistic infection, reducing HIV viremia, and lessening immune system deterioration in HIV-infected persons. For the AZT-alone arm, AZT dosing will be the standard regimen of 200 mg q4h. Persons on the AZT + IFN combination arm will receive AZT 100 mg q4h with IFN beginning at 1 million units qd, escalating up to 2.5 million units at 2 weeks, then in increments of 2.5 million units every 2 weeks. Patients on the IFN-alone arm will begin therapy at 5 million units qd and escalate in 2.5 million unit increments every 2 weeks, unless escalations are precluded by toxicity. Patients who have evidence of HIV infection and CD4 count greater than or equal to 500 will be randomized to one of the three treatment groups. Patients will continue to be treated with their assigned medication until intolerable toxicity, opportunistic infection, or progressive Kaposi's sarcoma develops, or CD4 count declines to less than 200/mm(3).
Long-Term Follow-up: Extension Phase (Natural History Study)
This protocol was initiated in 1988 and was the first study to evaluate early intervention with antiretroviral agents in patients with HIV infection. Our statistically significant findings during this pre-HAART era showed that interferon-alpha decreased HIV RNA viral load levels, both alone and in combination with AZT. Research medication has not been administered since January of 1997, but this cohort still serves as an important source of data regarding the long-term medical course of patients who have received an early intervention for HIV infection. Participants will remain in long-term follow-up in order to provide valuable information regarding the long-term outcomes of patients receiving anti-HIV treatment, and to provide information on the long-term consequences of therapy. Hence, this study is analogous to a longitudinal natural history study.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
Over 18 years of age.
T4 lymphocyte count greater than or equal to 500/mm3.
Infection with HIV as documented by positive ELISA and Western blot and positive HIV culture or positive p24 antigen or positive polymerase chain reaction.
Absence of current opportunistic infection (defined for purposes of this study as: candidiasis, cryptosporidiosis, mycobacterial infection, persistent herpes simplex infection, isosporiasis, cytomegalovirus infection, toxoplasmosis, pneumocystosis, salmonellosis, and cryptococcosis). Routine clinical methods and observations shall be performed to exclude such patients.
Patients must be afebrile (Temperature less the 38 degrees Centigrade orally) without antipyretics for at least 72 hours prior to enrollment.
Performance status 0, 1, or 2.
Relatively stable clinical condition, with no deterioration of performance status in the month prior to enrollment.
Ability to give informed consent and willing to comply with all procedures and visits scheduled.
Suitability of I.V. access for the scheduled blood tests.
Normal renal function as defined by BUN less than or equal to 30 and creatinine less than or equal to 1.5.
Normal hepatic function with transaminases and alkaline phosphatase less than 5 times the upper limit of normal range.
Hemoglobin greater than or equal to 10 gm/dl, total granulocyte count greater than or equal to 1250/mm(3), platelet count greater than or equal to 125,000/mm(3).
No previous therapy for KS within the month prior to enrollment, and no prior exposure to investigational agents. Prior exposure to AZT will not disqualify a patient, however patients will be stratified on this basis.
EXCLUSION CRITERIA:
Patients with malignancy other than Kaposi's sarcoma are specifically excluded from this study.
Pregnant women, nursing mothers, or women of childbearing potential who are not employing effective means of contraception or abstinence.
Patients who currently use illicit drugs.
Patients receiving systemically and potentially myelosuppressive drugs (such as TMP/SMX, pyrimethamine-sulfa or DHPG), nephrotoxic agents (such as amphotericin B or aminoglycosides), or cytotoxic or experimental chemotherapy.
Patients with a history of significant depressive disorder.
Patients with a history of an AIDS-defining opportunistic infection.
After enrollment, a patient will be excluded from further participation in the study for any of the following reasons:
Serious infection not cleared by antibiotic therapy. The occurrence of a life-threatening infection, whether or not considered to be opportunistic, will prompt a discontinuation of therapy during the infection and for 2 weeks following its successful resolution. Therapy will then be re-initiated unless (1) in the investigator's judgment re-treatment with either or both of the study medications would be contraindicated for other reasons or (2) therapy had been held for more than 6 weeks.
Decrease in percent CD4 to less than 20 percent or in absolute CD4 count to less than 200/mm(3) on 3 consecutive blood tests.
Systemic allergic reaction to either study medication, characterized by angioedema, bronchial constriction, or anaphylaxis.
It is the principal investigator's judgment that the patient is too ill to continue in the trial.
Toxicity necessitating withdrawal.
Patient non-compliance: A patient who is not taking medication as directed or who is not keeping appointments will not be allowed to continue on this study.
Rapid or life-threatening progression of KS such that the principal investigator believes other therapies would be in the patient's best interest.
Voluntary withdrawal: A patient may remove himself from study at any time. The patient will be allowed to withdraw without prejudice.
Termination of the study by the principal investigator, sponsor, or the FDA.
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United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Principal Investigator: | Mary E Wright, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
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Additional Information:
Publications:
Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ) |
ClinicalTrials.gov Identifier: | NCT01125228 History of Changes |
Other Study ID Numbers: | 880172, 88-I-0172 |
Study First Received: | May 15, 2010 |
Last Updated: | January 24, 2013 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
AIDS Antiretroviral Kaposi's Sarcoma |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Interferon-alpha Interferons Zidovudine |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Anti-HIV Agents |
ClinicalTrials.gov processed this record on February 24, 2013