A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3

HIV Infections Clinical Trial

Official title:

A Randomized Phase II Study of Two Doses of Interferon Alfa-2a (IFN Alfa-2a) in Combination With Zidovudine (AZT) and Dideoxycytidine (ddC) Versus AZT and ddC Only in Patients With HIV Infection and Less Than 400 CD4 Cells/mm3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000754
• Other study ID #: ACTG 197
• Secondary ID: 11173
• Status: Completed
• Phase: Phase 2
• Est. completion date: February 1995

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the safety and efficacy of two doses of interferon alfa-2a ( IFN alfa-2a ) in combination with zidovudine ( AZT )/zalcitabine ( ddC ) versus AZT/ddC only in patients with HIV infection and CD4 count < 400 cells/mm3.

AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects.

Description:

AZT and ddC inhibit HIV by acting as reverse transcriptase chain terminators, while IFN alfa-2a inhibits translation of viral proteins. Combining agents that act at different sites of viral replication may improve HIV inhibition and produce more effective and sustained anti-HIV effects.

Patients are randomly assigned to one of three treatment arms to receive AZT/ddC alone or combined with one of two doses of IFN alfa-2a. Treatment continues for up to 12 months after enrollment of the last patient. Patients are followed at 2, 4, and 8 weeks and every 8 weeks thereafter. Mean duration of follow-up is expected to be 13 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1995
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Isoniazid for < grade 2 peripheral neuropathy (if patient is also taking 50 mg/day pyridoxine).

• Phenytoin for < grade 2 peripheral neuropathy.

• A 21-day course of adjuvant systemic corticosteroid therapy for moderate to severe Pneumocystis carinii pneumonia (PCP).

• Chemoprophylaxis for PCP, candidiasis, herpes simplex infection (up to 1 g acyclovir daily), and Mycobacterium tuberculosis.

Patients must have:

• HIV infection.

• CD4 count < 400 cells/mm3 within 30 days prior to study entry.

NOTE:

• Minimal Kaposi's sarcoma is allowed.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• Active opportunistic infection requiring acute therapy.

• Need for maintenance therapy for cytomegalovirus infection, toxoplasmic encephalitis, or mycobacterial infection.

• Malignancy (other than minimal Kaposi's sarcoma) requiring therapy.

• Grade 2 or worse peripheral neuropathy.

Concurrent Medication:

Excluded:

• Other antiretroviral drugs, biologic response modifiers, cytotoxic chemotherapy, or investigational drugs (unless approved by the protocol chairs).

• Recombinant erythropoietin, G-CSF, or GM-CSF.

• Drugs that cause peripheral neuropathy, e.g., gold, hydralazine, nitrofurantoin, vincristine, cisplatin, disulfiram, and diethyldithiocarbamate (unless approved by the protocol chairs).

Concurrent Treatment:

Excluded:

• Radiation therapy (unless approved by the protocol chairs).

Patients with the following prior conditions are excluded:

• History of intolerance to AZT at 600 mg/day or less.

• Unexplained temperature of 38.5 degrees C persisting for 14 days or longer.

• Unexplained, chronic diarrhea defined as 3 or more stools per day persisting for 14 days or longer.

Prior Medication:

Excluded:

• Acute therapy for opportunistic infection within 14 days prior to study entry.

• Prior ddC, ddI, or IFN alfa-2a.

Active substance abuse.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infections

Intervention

Drug:
• Interferon alfa-2a

• Zidovudine

• Zalcitabine

Locations

Country	Name	City	State
United States	Alabama Therapeutics CRS	Birmingham	Alabama
United States	Ucsd, Avrc Crs	La Jolla	California
United States	Univ. of Miami AIDS CRS	Miami	Florida
United States	UCSD Maternal, Child, and Adolescent HIV CRS	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Glaxo Wellcome, Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fischl MA, Richman DD, Saag M, Meng TC, Squires KE, Holden-Wiltse J, Meehan PM. Safety and antiviral activity of combination therapy with zidovudine, zalcitabine, and two doses of interferon-alpha2a in patients with HIV. AIDS Clinical Trials Group Study 197. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Dec 1;16(4):247-53. — View Citation