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| Sponsored by: |
Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002014 |
Purpose
To determine the safety and tolerance of various combinations of zidovudine (AZT) and didanosine (ddI) administered concurrently. To determine the pharmacokinetics of concurrent AZT and ddI administered orally. To evaluate the antiviral, immunologic and virologic effects of AZT and ddI administered concurrently.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Zidovudine Drug: Didanosine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison, Pharmacokinetics Study |
| Official Title: | A Phase I Study to Evaluate the Pharmacokinetics, Safety and Antiviral Effects of Concurrent Administration of Zidovudine (AZT) and 2'3'-Dideoxyinosine (ddI) in Patients With Human Immunodeficiency Virus (HIV) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have the following:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Visceral or progressive Kaposi's sarcoma (KS) (defined by > 10 new lesions in the thirty days prior to entry) or patients who require chemotherapy or radiation therapy for Kaposi's sarcoma. Other concurrent neoplasms other than basal cell carcinoma of skin or in situ carcinoma of the cervix. Malabsorption as defined by persistent diarrhea ( > 4 stools/day for four weeks) which is unresponsive to antidiarrheal agents. Opportunistic infection requiring maintenance therapy. History of Central Nervous System opportunistic infections (e.g., toxoplasmosis, cryptococcosis). History of seizure disorders. Prior history of pancreatitis. History of peripheral neuropathy or any significant signs or symptoms of neurological disease. Examinations for peripheral neuropathy should assess changes in extremities. Clinically significant hyperuricemia (tophaceous gout, urate nephropathy). History of cardiomyopathy.
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded within 2 weeks of study entry:
Active substance abuse that would impair compliance with study procedures.
Contacts and Locations| United States, California | |
| San Francisco AIDS Clinic / San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Massachusetts | |
| New England Med Ctr | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Washington | |
| Univ of Washington | |
| Seattle, Washington, United States, 981224304 | |
More Information
| Study ID Numbers: | 052A, 01 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002014 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Didanosine Drug Evaluation Zidovudine |
|
Antimetabolites Sexually Transmitted Diseases, Viral Anti-HIV Agents Acquired Immunodeficiency Syndrome Zidovudine Antiviral Agents Immunologic Deficiency Syndromes |
Reverse Transcriptase Inhibitors Virus Diseases Didanosine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
|
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections |
Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |