Clinical Trials Logo
  1. Home
  2. HIV Infections
  3. NCT00001105

The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV

HIV Infections Clinical Trial

Official title:
A Phase I Clinical Trial to Study the Toxicity, Pharmacokinetics, and Efficacy of Human Monoclonal Antibody, F105, for Treating Human Immunodeficiency Virus Infection.

Clinical Trial Summary

To determine the safety and pharmacokinetics of F105 human monoclonal antibody both following a single dose and during intermittent administration in HIV-infected patients. To determine specific dose concentrations sufficient to achieve efficacy and avoid toxicity. To determine the effect of F105 on virologic, immunologic, and serologic parameters. Early in the course of HIV infection, the primary humoral immune response appears to be highly strain specific and to be directed at a hypervariable portion of the viral gp120. The F105 human monoclonal antibody reacts with the CD4 binding region of gp120 and has been shown to neutralize the IIIB, SF2, and MN strains of HIV at concentrations readily achievable in humans.

Clinical Trial Description

Early in the course of HIV infection, the primary humoral immune response appears to be highly strain specific and to be directed at a hypervariable portion of the viral gp120. The F105 human monoclonal antibody reacts with the CD4 binding region of gp120 and has been shown to neutralize the IIIB, SF2, and MN strains of HIV at concentrations readily achievable in humans. In Part A, three cohorts of four patients each receive a single intravenous (IV) injection of F105 human monoclonal antibody at 1 of 3 doses. The IV catheter will remain in the patient's arm for 12 hours after injection for subsequent drawing of blood samples. The third group (highest dose) will be studied only after the first two groups are analyzed for pharmacokinetics. No more than two patients are enrolled per week. Patients on Part A undergo follow-up three to four times within the first week after injection and weekly thereafter for 7 weeks. Pharmacokinetic and toxicity data generated from Part A will be used to select two dose levels for intermittent administration in Part B. In this part, cohorts of four to six patients receive one of two doses of F105 for 8-12 weeks. Per 9/30/94 amendment, eight patients receive one dose of F105 every 21 days for four doses (dose determined from analysis of Part A data). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00001105
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Completion date March 1996
View Details
See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Completed 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
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision 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
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated 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