Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Triangle Pharmaceuticals |
---|---|
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002412 |
The purpose of this study is to see if it is safe and effective to give MKC-442 plus stavudine (d4T) plus didanosine (ddI) plus hydroxyurea.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: Emivirine Drug: Hydroxyurea Drug: Stavudine Drug: Didanosine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Safety Study |
Official Title: | A Randomized, Double-Blind Study of MKC-442 Combined With Stavudine, Didanosine, and Hydroxyurea in HIV-Infected Patients Who Are Protease Inhibitor Experienced and Non-Nucleoside Reverse Transcriptase Inhibitor Naive |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Based on medical history, medical condition, prior use of antiretroviral drugs, and genotypic analysis of the predominant strain of HIV-1 isolated from the plasma, administration of a combination of two or more available antiretroviral agents by prescription may be given with MKC-442.
Patient must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Treatment:
Excluded:
- Any experimental antiretroviral therapy or immunomodulators directed against HIV-1, e.g., IL-4, cyclosporine steroids at doses greater than 40 mg/day.
Prior Medication:
Excluded:
- Non-nucleoside reverse transcriptase inhibitor therapy.
Prior Treatment:
Excluded:
Risk Behavior:
Excluded:
Active substance abuse that may interfere with compliance or protocol evaluations.
Study ID Numbers: | 292C, MKC-305 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002412 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Didanosine Drug Therapy, Combination Stavudine Hydroxyurea |
Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load MKC 442 |
Antimetabolites Sexually Transmitted Diseases, Viral Stavudine Anti-HIV Agents Hydroxyurea Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes |
Reverse Transcriptase Inhibitors Protease 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 Stavudine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hydroxyurea Hematologic Agents Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors |
RNA Virus Infections Antisickling Agents 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 |