HIV InfectionsPhase 1NCT00001105
The Safety and Effectiveness of Human Monoclonal Antibody, F105, in the Treatment of HIV
A Phase 1 study testing F105 Monoclonal Antibody (Human) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- F105 Monoclonal Antibody (Human)
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Mar 1996
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- PART B ONLY. Allowed:
- Concomitant AZT or other antiretroviral drugs if patient is on a stable dose of such therapy within 3 months prior to study entry.
- Patients must have:
- Documented HIV-1 infection.
- CD4 count 200 - 500 cells/mm3 (Part A) or <= 400 cells/mm3 (Part B, per amendment).
Show all 16Show fewer
- No diagnosis of AIDS (Part A only, per amendment).
- Life expectancy of at least 6 months.
- Part B patients only (per amendment):
- Primary (viral) isolates sensitive to F105 antibody using the yield reduction assay currently under development by ACTG, determined within 15-90 days prior to study entry.
- Plasma viremia by qualitative plasma culture.
- NO active opportunistic infection within 6 weeks prior to drawing of first isolate.
- NO AIDS-related malignancy other than minimal Kaposi's sarcoma.
- Prior Medication:
- Allowed:
- Prior AZT or other nucleoside antiviral agents.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Evidence of active renal disease as manifested by sediment containing red or white cell casts.
- Concurrent Treatment:
- Excluded:
- Red cell transfusions administered to maintain hemoglobin at acceptable level or alleviate symptoms of anemia.
Show all 24Show fewer
- Prior Medication:
- Excluded within 6 weeks prior to study entry:
- Intravenous gamma globulin.
- Chemotherapy.
- Corticosteroids.
- Other experimental therapy.
- EXCLUDED IN ALL PATIENTS:
- Immunosuppressive treatments, cytokine therapy, or biologic response modifiers not included in this study, including interferons or adjuvant treatment for chronic and severe fungal infections such as cryptococcal meningitis.
- Intravenous gamma globulin.
- Chemotherapy.
- Corticosteroids.
- Other experimental therapy.
- G-CSF, GM-CSF, or erythropoietin.
- EXCLUDED IN PART A ONLY:
- Drugs known to enhance or block metabolism of other drugs.
- EXCLUDED IN PART B ONLY:
- AZT or other antiretroviral drugs IF INITIATED during or within 1 month after completion of study.
- Active alcohol or drug abuse that may compromise ability to comply with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215
About this study
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.
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.
Read the detailed 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).
- Conditions
- HIV Infections
- Being tested
- F105 Monoclonal Antibody (Human)
- Keywords
- Antibodies, Monoclonal, AIDS-Related Complex, Immunization, Passive
- Medical subject headings
- HIV Infections, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F105 Monoclonal Antibody (Human)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionMar 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 8 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Samore MH, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001105
- Sponsor's protocol ID
- ACTG 232
- Other IDs
- 11209
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Wolfe EJ, Cavacini LA, Samore MH, Posner MR, Kozial C, Spino C, Trapnell CB, Ketter N, Hammer S, Gambertoglio JG. Pharmacokinetics of F105, a human monoclonal antibody, in persons infected with human immunodeficiency virus type 1. Clin Pharmacol Ther. 1996 Jun;59(6):662-7. doi: 10.1016/S0009-9236(96)90006-5.
PubMed 8681491
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00001105
- Acronym / sponsor ID
- ACTG 232
- Conditions
- HIV Infections
- Keywords
- Antibodies, Monoclonal, AIDS-Related Complex, Immunization, Passive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Mar 1996 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Concomitant AZT or other antiretroviral drugs if patient is on a stable dose of such therapy within 3 months prior to study entry.
- Documented HIV-1 infection.
- CD4 count 200 - 500 cells/mm3 (Part A) or <= 400 cells/mm3 (Part B, per amendment).
- No diagnosis of AIDS (Part A only, per amendment).
- Life expectancy of at least 6 months.
Key exclusion criteria (24 listed)
- Evidence of active renal disease as manifested by sediment containing red or white cell casts.
- Red cell transfusions administered to maintain hemoglobin at acceptable level or alleviate symptoms of anemia.
- Intravenous gamma globulin.
- Chemotherapy.
- Corticosteroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F105 Monoclonal Antibody (Human) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Background: PubMed 8681491Wolfe EJ, Cavacini LA, Samore MH, Posner MR, Kozial C, Spino C, Trapnell CB, Ketter N, Hammer S, Gambertoglio JG. Pharmacokinetics of F105, a human monoclonal antibody, in persons infected with human immunodeficiency virus type 1. Clin Pharmacol Ther. 1996 Jun;59(6):662-7. doi: 10.1016/S0009-9236(96)90006-5.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samore MH study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F105 Monoclonal Antibody (Human) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.