Multiple Dose Comparison of the Effect of Two Dose Combinations of Tipranavir/Ritonavir (TPV/RTV), on the Pharmacokinetic Characteristics of Efavirenz (Sustiva®) in Healthy Adult Volunteers
NCT02253823 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2014-10-01
Summary
The objective of this study was to characterize the effects of two dose combinations of tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg), administered daily and BID, on the pharmacokinetics of efavirenz (EFV), 600 mg daily
Conditions
- Healthy
Interventions
- DRUG
-
EFV
- DRUG
-
TPV/RTV - low dose
- DRUG
-
TPV/RTV - high dose
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2001-12-31
- Primary Completion
- 2002-03-31
More Related Trials
-
A Phase I, Open-label Trial to Explore the Pharmacokinetics, Safety and Tolerability of TMC278 (Rilpivirine) 25 mg Once Daily Following a 2-week Period Receiving Efavirenz, in Healthy Male and Female Volunteers
NCT01268839 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Effectiveness of an Anti-HIV Drug Combination Taken Twice Daily
NCT00002241 ·Status: UNKNOWN ·Phase: PHASE2
-
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC
NCT00002208 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Reduced Versus Standard Dose Efavirenz (EFV) Plus Two Nucleotides in Antiretroviral-naïve Adults.
NCT01011413 ·Status: COMPLETED ·Phase: PHASE3
-
The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine
NCT00002381 ·Status: COMPLETED ·Phase: PHASE1
-
Study of Treatment of Antiretroviral-naive, HIV-1-Infected Patients Comparing Tenofovir Disoproxil Fumarate Administered in Combination With Lamivudine and Efavirenz vs. Stavudine, Lamivudine and Efavirenz.
NCT00158821 ·Status: COMPLETED ·Phase: PHASE3
-
Bioavailability of 2 Different Nevirapine Extended Release Formulations Compared to Viramune® in HIV-1 Infected Subjects
NCT02194179 ·Status: COMPLETED ·Phase: PHASE1
-
Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects
NCT00000882 ·Status: COMPLETED ·Phase: PHASE2
-
TMC114-C213: A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose-response of TMC114/RTV in 3-class-experienced HIV-1 Infected Patients, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV.
NCT00650832 ·Status: COMPLETED ·Phase: PHASE2
-
Bioequivalency Study of Zidovudine Under Fasting Conditions
NCT00602550 ·Status: COMPLETED ·Phase: NA
-
A Study of Two Anti-HIV Drug Combinations
NCT00002203 ·Status: COMPLETED ·Phase: NA
-
Effectiveness and Safety of Epivir/Ziagen/Zerit (3TC/ABC/d4T) Versus Epivir/Ziagen/Sustiva (3TC/ABC/EFV) Versus Epivir/Ziagen/Agenerase/Norvir (3TC/ABC/APV/RTV) in HIV Patients Who Have Never Received Treatment
NCT00005017 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors
NCT00002235 ·Status: COMPLETED ·Phase: PHASE2
-
The Safety and Effectiveness of Adefovir Dipivoxil in the Treatment of HIV-Infected Patients
NCT00001082 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.
NCT01737359 ·Status: TERMINATED ·Phase: PHASE2
-
A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
NCT00002369 ·Status: COMPLETED ·Phase: NA
-
A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials
NCT02187107 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 2 Study to Evaluate Pharmacokinetics, Safety and Efficacy of TMC114/Ritonavir (Rtv) in Human Immunodeficiency Virus (HIV)-1 Infected Children and Adolescents
NCT00355524 ·Status: COMPLETED ·Phase: PHASE2
-
A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study
NCT00128830 ·Status: COMPLETED ·Phase: PHASE2
-
A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell
NCT00002323 ·Status: COMPLETED ·Phase: NA
-
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
NCT00002406 ·Status: COMPLETED ·Phase: PHASE3
-
TMC125-C216: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.
NCT00255099 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants
NCT02275065 ·Status: COMPLETED ·Phase: PHASE1
-
A Comparison of Emtricitabine and Stavudine Used With Didanosine Plus Efavirenz in HIV-Infected Patients Who Have Not Taken Anti-HIV Drugs
NCT00006208 ·Status: UNKNOWN ·Phase: PHASE3
-
KIVEXA Vs TRUVADA, Both Administered With Efavirenz, In ART-Naive Subjects
NCT00549198 ·Status: COMPLETED ·Phase: PHASE4