A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past
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Purpose
To compare the efficacy, safety and tolerance, and other clinical and immunologic effects of zidovudine (AZT) plus zalcitabine (dideoxycytidine; ddC), AZT plus didanosine (ddI), and AZT alternating monthly with ddI as measured by differences in survival among HIV-infected persons who have received 6 or more months of nucleoside monotherapy and have a CD4 count greater than or equal to 50 cells/mm3.
Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Zidovudine Drug: Zalcitabine Drug: Didanosine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Three-Arm Study Comparing Combination to Monthly Alternating Nucleoside Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3) With a Prior History of Nucleoside Therapy |
| Estimated Enrollment: | 654 |
| Study Completion Date: | May 1993 |
Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs.
Patients are randomized to one of three treatment arms: AZT plus ddI, AZT plus ddC, and AZT alone alternating monthly with ddI. Half of the patients receiving AZT alternating monthly with ddI will start with AZT, while the other half will start with ddI. Treatment continues until death or termination of the study. Patients are followed every 4 weeks. The study will include a subset of patients for whom virologic, pharmacokinetic, and macroneurologic assessments will be made.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
- PCP prophylaxis.
Allowed:
- Erythropoietin.
- Prophylaxis for MAI or fungal infections.
- Antibiotics.
- Over-the-counter, alternative, or regularly prescribed drugs.
- Steroids, if for < 21 days.
Concurrent Treatment:
Allowed:
- Radiation therapy for cutaneous Kaposi's sarcoma.
Patients must have:
- HIV infection.
- CD4 count <= 50 cells/mm3.
- Prior nucleoside monotherapy for at least 6 months.
- Life expectancy of at least 6 months.
Prior Medication: Required:
- Nucleoside monotherapy for at least 6 months. Active alcohol or drug abuse.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Severe peripheral neuropathy.
- Psychological or emotional problems sufficient to prevent study compliance.
Concurrent Medication:
Excluded:
- Systemic chemotherapy for malignancy.
- Acute or induction therapy for opportunistic infection.
Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis.
- Grade 3 or greater toxicity to AZT, ddI, or ddC on two or more occasions.
Prior Medication:
Excluded:
- Non-study nucleosides or biologic response modifiers within 7 days prior to study entry.
- Acute therapy for opportunistic process within 14 days prior to study entry.
- Acute systemic therapy for other medical conditions within 14 days prior to study entry.
Contacts and Locations
Show 37 Study Locations| Study Chair: | WK Henry | |
| Study Chair: | JO Kahn | |
| Study Chair: | HH Balfour |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001029 History of Changes |
| Other Study ID Numbers: | ACTG 193, 11168 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Zalcitabine Didanosine Drug Therapy, Combination Acquired Immunodeficiency Syndrome Zidovudine |
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 Zalcitabine Didanosine |
Zidovudine Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 19, 2013