Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Recruitment status was Active, not recruiting
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Purpose
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 |
|---|---|---|
|
HIV Infections |
Drug: Indinavir sulfate Drug: Ritonavir Drug: Lamivudine Drug: Stavudine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| 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.
Eligibility| 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:
- Are HIV-positive.
- Are at least 18 years old.
- Have a viral load of 5,000 copies/ml or greater.
- Have a CD4 count of at least 50 cells/mm3.
Exclusion Criteria
Patients will not be eligible for this study if they:
- Have taken any antiretroviral (anti-HIV) agent.
- Are pregnant.
Contacts and Locations| 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 | |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002451 History of Changes |
| Other Study ID Numbers: | 246U, 104-00 |
| Study First Received: | January 17, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Drug Therapy, Combination Stavudine HIV Protease Inhibitors CD4 Lymphocyte Count Ritonavir |
Lamivudine Indinavir Reverse Transcriptase Inhibitors Anti-HIV Agents Viral Load |
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 HIV Protease Inhibitors Indinavir Ritonavir |
Stavudine Lamivudine Reverse Transcriptase Inhibitors Anti-HIV Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Antimetabolites Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013