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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 Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on 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 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 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 research trials and 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 medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including 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. 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 Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a 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. Participants oftentimes recieve the finest healthcare available for their 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 condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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  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
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
For Condition: HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche , National Institute of Allergy and Infectious Diseases (NIAID),Glaxo Wellcome
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
FischlMA, Study Chair,
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Additional Information:
Study ID Numbers: ACTG 197;
Study Start Date:
Record last reviewed: February 1995
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000754
Other Hiv Infections Studies:
1. Computer-Assisted Adherence Program for Patients Taking Anti-HIV Drugs
2. Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
3. Interleukin-2 (IL-2) Treatment for HIV Infected Patients Who Have Interrupted Their Anti-HIV Drug Therapy
4. A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 100 mcg of Env 2-3 in MF59
5. Phase III Randomized Double-Blind Study Comparing Megestrol Acetate at 800 mg/day, and Placebo in AIDS Patients With Anorexia and Cachexia
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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
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