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Sponsored by: |
Merck |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002451 |
The purpose of this study is to see if it is safe to give indinavir (IDV) and ritonavir (RTV) in combination with stavudine (d4T) and lamivudine (3TC) to HIV-positive patients who have never received anti-HIV therapy. This study will look at the effectiveness of this drug combination and side effects.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir Drug: Lamivudine Drug: Stavudine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison, Safety Study |
Official Title: | A Multicenter, Open-Label, 24-Week Pilot Study to Evaluate the Safety and Activity of Indinavir Sulfate 1200 Mg q.d. and Ritonavir 200 Mg q.d. in Combination With Stavudine and Lamivudine in Treatment Naive HIV-1 Infected Patients |
Estimated Enrollment: | 8 |
Patients entering this study initiate antiretroviral therapy. For 24 weeks patients receive daily dosages of IDV, RTV, 3TC, and d4T. Patients are seen at Day 1 and at Weeks 2, 4, 8, 12, 16, 20, and 24 for physical examinations, pregnancy testing, and blood sampling to monitor CD4 count and viral load. On Day 14, blood is drawn frequently for 24 hours for IDV and RTV pharmacokinetic sampling. The incidence of serious and drug-related adverse events and of adverse events leading to study discontinuation is tabulated.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 33136 | |
United States, New York | |
Albany Med College | |
Albany, New York, United States, 12208 | |
SUNY at Stony Brook / Division of Infectious Diseases | |
Stony Brook, New York, United States, 11794 |
Study ID Numbers: | 246U, 104-00 |
Study First Received: | January 17, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002451 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Drug Therapy, Combination Stavudine HIV Protease Inhibitors CD4 Lymphocyte Count Ritonavir |
Lamivudine Indinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
Antimetabolites Sexually Transmitted Diseases, Viral HIV Protease Inhibitors Anti-HIV Agents Stavudine Indinavir Acquired Immunodeficiency Syndrome Lamivudine Antiviral Agents |
Immunologic Deficiency Syndromes Protease Inhibitors Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents HIV Infections Ritonavir Sexually Transmitted Diseases Retroviridae Infections |
Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Stavudine Slow Virus Diseases Indinavir Molecular Mechanisms of Pharmacological Action Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors HIV Protease Inhibitors |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Protease Inhibitors Virus Diseases HIV Infections Ritonavir Sexually Transmitted Diseases Lentivirus Infections |