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A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| HIV Infections | Drug: Zidovudine Drug: Zalcitabine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002 |
| Estimated Enrollment: | 120 |
| Study Completion Date: | September 1992 |
While treatment with AZT has been found to be effective in prolonging survival and reducing the numbers of opportunistic infections in patients with AIDS, during the second year of administration of AZT an acceleration in mortality has been observed. The reasons for this are not known at this time. The study of what may be an AZT-resistant strain of HIV may benefit patients who have been and are still receiving AZT or another drug used in treating HIV ddC. It is hoped that the comparison of the effectiveness of AZT and ddC will benefit in the treatment of these patients.
Following tests to evaluate their health, patients are chosen at random to receive either AZT or ddC. AZT is given by mouth at the patients' current dose. ddC is given by mouth every 8 hours. Treatment continues for up to 12 months. Patients are required to visit the clinic every 2 weeks up to week 12 and then once a month. Blood samples are taken to monitor the safety and effectiveness of treatment.
Eligibility| Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Required:
- Prior zidovudine (AZT) therapy for 9 months.
Concurrent Medication:
Allowed:
- Chemoprophylaxis for Pneumocystis carinii pneumonia (PCP) with aerosolized pentamidine of 300 mg every 4 weeks through the Respirgard II nebulizer.
- Maintenance treatment with pyrimethamine, sulfadiazine, amphotericin, fluconazole, ketoconazole, acyclovir, or inhaled pentamidine for subjects who have recovered from toxoplasmosis, cryptococcosis, candidiasis, herpes infection, or PCP.
- Dapsone for PCP.
- Pyrimethamine-sulfadoxine for toxoplasmosis.
- Ganciclovir (DHPG) for maintenance only for cytomegalovirus (CMV) retinitis.
- Note: Any approved medications can be used to treat an opportunistic infection. All concurrent medications should be kept to a minimum and recorded.
Patients must be positive for HIV by ELISA test and must have been receiving zidovudine (AZT) therapy for at least 9 months and have received AZT within 90 days prior to entry into the study.
Patients may be transfusion dependent as long as no more than 3 units of blood are needed in a 21-day period and the hemoglobin does not fall below 6.4 g/dl on two consecutive occasions despite the transfusions.
Exclusion Criteria
Concurrent Medication:
Excluded:
- Antiretroviral study medications other than zidovudine (AZT) and biologic response modifiers.
- Corticosteroids and chronic aspirin.
- Cimetidine.
- Flurazepam.
- Indomethacin.
- Ranitidine.
- Probenecid.
- Other experimental medications.
Patients will be excluded from the study for the following reasons:
- Removal from zidovudine (AZT) during treatment on ACTG protocol 002 for recurrent grade 4 toxicity.
- Removal from prior dideoxycytidine (ddC) therapy for peripheral neuropathy = or > grade 3.
- Visceral or extensive Kaposi's sarcoma requiring therapy or another malignancy requiring therapy.
- Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults).
Prior Medication:
Excluded:
- Antiretroviral study medications other than zidovudine (AZT) and biologic response modifiers.
- Patients may not have visceral or extensive Kaposi's sarcoma requiring therapy or another malignancy requiring therapy.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00000682
| United States, California | |
| USC CRS | |
| Los Angeles, California, United States, 90033 | |
| Ucsd, Avrc Crs | |
| San Diego, California, United States, 92103 | |
| United States, Florida | |
| Univ. of Miami AIDS CRS | |
| Miami, Florida, United States, 33136 | |
| United States, Maryland | |
| Johns Hopkins Adult AIDS CRS | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Pennsylvania | |
| Pitt CRS | |
| Pittsburgh, Pennsylvania, United States | |
| Study Chair: | Fischl M | |
| Study Chair: | Richman D | |
| Study Chair: | Murray H |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000682 History of Changes |
| Other Study ID Numbers: |
ACTG 112 11087 ( Registry Identifier: DAIDS ES Registry Number ) |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 28, 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Zalcitabine Acquired Immunodeficiency Syndrome Zidovudine |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine |
Zalcitabine Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents |
ClinicalTrials.gov processed this record on July 21, 2017