Clinical Trials Logo
  1. Home
  2. HIV Infections
  3. NCT00002451

Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs

HIV Infections Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00002451
Study type Interventional
Source NIH AIDS Clinical Trials Information Service
Contact
Status Active, not recruiting
Phase Phase 2
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Recruiting NCT03256435 - PrEP Intervention for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Enrolling by invitation NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2
Recruiting NCT03271307 - Use of HIV Self-Test Kits to Increase Identification of HIV-Infected Individuals and Their Partners N/A
Recruiting NCT03577782 - Vedolizumab Treatment in HIV-Infected Subjects Without Previous Antiretroviral Therapy Phase 1/Phase 2
Active, not recruiting NCT01937455 - A Phase 1, Randomized, Blinded, Dose-escalation Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults. Phase 1
Active, not recruiting NCT01852942 - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV Phase 2
Withdrawn NCT01975012 - Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Active, not recruiting NCT01931358 - Study of Boosting Strategies After Vaccination With ALVAC-HIV and AIDSVAX® B/E Phase 2
Completed NCT01923610 - Safety and Immunological Response of a Boosting Dose of MVA-B in Healthy Volunteers After 4 Years of Receiving MVA-B Phase 1
Completed NCT01968551 - Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults Phase 3
Recruiting NCT01439503 - Safer Sex Program for Young African-American Men Phase 2
Terminated NCT01583439 - The Mochudi Prevention Project ART Protocol N/A
Completed NCT01053598 - Evaluation Of The Performance Of The Nitrate Reductase And Resazurin Titre Assay For The Detection of Mycobacterium Tuberculosis Complex From Sputum In A High Tb and Hiv Setting N/A
Completed NCT01440569 - Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults Phase 3