Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Verified July 2002
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: January 17, 2000
Last updated: June 23, 2005
Last Verified: July 2002
History of Changes
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.
Drug : Indinavir sulfate
Drug : Ritonavir
Drug : Lamivudine
Drug : Stavudine
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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- Have taken any antiretroviral (anti-HIV) agent.
- Are pregnant.
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002451
Locations Show More
|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|
Sponsors and CollaboratorsMerck Sharp & Dohme Corp.
|Responsible Party:||Merck Sharp & Dohme Corp.|
|ClinicalTrials.gov Identifier:||NCT00002451 History of Changes|
|Other Study ID Numbers:||246U|
|Study First Received:||January 17, 2000|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Drug Therapy, Combination
HIV Protease Inhibitors
CD4 Lymphocyte Count
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on March 16, 2018
This information is provided by ClinicalTrials.gov.