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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

NCT00000754

CompletedPhase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions: HIV Infections

Interventions: Interferon alfa-2a, Zidovudine, Zalcitabine

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (4)

Birmingham, Alabama, United States
La Jolla, California, United States
San Diego, California, United States
Miami, Florida, United States