HIV InfectionsPhase 1NCT00000977
Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
A Phase 1 study testing gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
To determine the minimal effective (immunogenic) dose of vaccine in asymptomatic HIV-1 seropositive individuals with > 400 cells/mm3 (CD4). To determine the dose-response to a 4 fold escalation of the immunizing dose. To describe both cellular and humoral immune responses to HIV-1 in the immunized individuals. 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?
- gp160 Vaccine (MicroGeneSys)
- Type of treatment
- Vaccines
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- Start not givento May 1993
- 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:
- Allowed:
- Acute use (< 14 days) of acyclovir for Herpes simplex virus infection or ketoconazole for symptomatic Candida infections.
- An additional group of up to 20 patients may be added to the study. Patients from ACTG 148 with a repeatedly negative delayed-type hypersensitivity (DTH) reaction who have reached their third dose of ID gp160 at 32 mcg and have failed to develop new proliferative response have the option, after a 2-month interval, to enter this protocol.
- They must meet inclusion and exclusion criteria that apply to this protocol.
- Patients with CD4 counts of 400 - 500 cells/mm3 must be informed of the recommended zidovudine (AZT) therapy and sign an informed consent statement declining AZT therapy.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Fever of > 100 degrees F persisting for > 15 days in a 30-day interval without definable cause.
- Recurrent oral candidiasis.
- Multidermatomal herpes zoster.
- Biopsy-proven hairy leukoplakia.
Show all 22Show fewer
- Fatigue/malaise of > 1 month duration that interferes with normal activities.
- Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam.
- Involuntary weight loss > 10 lbs or 10 percent of normal weight in a 6 month interval.
- Diarrhea (> 3 stools/day) for more than 30 days without definable cause.
- Concurrent Medication:
- Excluded:
- Antiretroviral agents of proven or potential efficacy or any potential immunoenhancing or immunosuppressive drugs.
- Patients with the following are excluded:
- Known hypersensitivity to insect cells or baculovirus.
- Abnormal chest x-ray taken within 3 months of study entry.
- Systemic symptoms thought to be due to HIV infection (other than lymphadenopathy). Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam.
- Unwilling or unable to give written informed consent.
- Prior Medication:
- Excluded within 90 days of study entry:
- Zidovudine (AZT), didanosine (ddI), or any potential antiretroviral or immunomodulating agents.
- Active substance abuse (either continuing daily alcohol abuse or intravenous drug use).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Stanford CRS
Palo Alto, California, 94305
About this study
To determine the minimal effective (immunogenic) dose of vaccine in asymptomatic HIV-1 seropositive individuals with > 400 cells/mm3 (CD4). To determine the dose-response to a 4 fold escalation of the immunizing dose. To describe both cellular and humoral immune responses to HIV-1 in the immunized individuals. To describe the effects of this immunization on general immunological, virological and clinical parameters. To evaluate the safety of injecting recombinant gp160 in this population. To evaluate the extent of variability between different lots of gp160 (arms C1 and C2). It might be possible to increase immune responses or to induce new types of immune responses to HIV in some infected individuals by means of a vaccine, which could result in an immunological, virological or clinical benefit.
Read the detailed description
It might be possible to increase immune responses or to induce new types of immune responses to HIV in some infected individuals by means of a vaccine, which could result in an immunological, virological or clinical benefit.
ORIGINAL DESIGN: Patients are randomized to one of five groups to receive, intramuscularly, one of four dosages of gp160 or hepatitis B vaccine as a control. Treatments are given at 0, 1, 3, 6, 9, and 12 months and patients are followed for up to 2 years. Patients in any of the 5 groups will have the option of switching to another dosage group if an interim analysis at 6 months shows significant differences in patient response. AMENDED: 10/23/90 52 eligible patients are randomized to one of 6 study groups. Five groups of 8 individuals receive one of 4 dosage levels of gp160 (Groups A, B, C1, C2, and D), and 12 patients receive a single dosage level of hepatitis B vaccine as a control (Group E). Per 2/19/92 amendment, patients may elect to continue receiving vaccine beyond 12 months, with the doses given either every 3 months or every 6 months.
- Conditions
- HIV Infections
- Being tested
- gp160 Vaccine (MicroGeneSys)
- Keywords
- Vaccines, Synthetic, HIV Seropositivity, HIV-1, Drug Evaluation, AIDS Vaccines, HIV Therapeutic Vaccine
- Medical subject headings
- HIV Infections, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gp160 Vaccine (MicroGeneSys)Biological
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 completionMay 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 52 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Protein Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Valentine F, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000977
- Sponsor's protocol ID
- ACTG 137
- Other IDs
- 11112
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Katzenstein DA, Kundu S, Spritzler J, Smoller BR, Haszlett P, Valentine F, Merigan TC. Delayed-type hypersensitivity to recombinant HIV envelope glycoprotein (rgp160) after immunization with homologous antigen. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):341-7. doi: 10.1097/00126334-199912010-00004.
PubMed 10634195Kundu SK, Katzenstein D, Valentine FT, Spino C, Efron B, Merigan TC. Effect of therapeutic immunization with recombinant gp160 HIV-1 vaccine on HIV-1 proviral DNA and plasma RNA: relationship to cellular immune responses. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Aug 1;15(4):269-74. doi: 10.1097/00042560-199708010-00004.
PubMed 9292585Valentine F, et al. A randomized, controlled study of immunogenicity of rgp160 vaccine in HIV-infected subjects. Int Conf AIDS. 1992 Jul 19-24;8(1):Tu39 (abstract no TuB 0561)
Valentine FT, Kundu S, Haslett PA, Katzenstein D, Beckett L, Spino C, Borucki M, Vasquez M, Smith G, Korvick J, Kagan J, Merigan TC. A randomized, placebo-controlled study of the immunogenicity of human immunodeficiency virus (HIV) rgp160 vaccine in HIV-infected subjects with > or = 400/mm3 CD4 T lymphocytes (AIDS Clinical Trials Group Protocol 137). J Infect Dis. 1996 Jun;173(6):1336-46. doi: 10.1093/infdis/173.6.1336.
PubMed 8648205Kundu SK, Katzenstein D, Moses LE, Merigan TC. Enhancement of human immunodeficiency virus (HIV)-specific CD4+ and CD8+ cytotoxic T-lymphocyte activities in HIV-infected asymptomatic patients given recombinant gp160 vaccine. Proc Natl Acad Sci U S A. 1992 Dec 1;89(23):11204-8. doi: 10.1073/pnas.89.23.11204.
PubMed 1360665
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
- Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity
- ClinicalTrials.gov ID
- NCT00000977
- Acronym / sponsor ID
- ACTG 137
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, HIV Seropositivity, HIV-1, Drug Evaluation, AIDS Vaccines, HIV Therapeutic Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Protein Sciences Corporation
- Study completion
- May 1993 (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 minimal effective (immunogenic) dose of vaccine in asymptomatic HIV-1 seropositive individuals with > 400 cells/mm3 (CD4). To determine the dose-response to a 4 fold escalation of the immunizing dose. To describe both cellular and humoral immune responses to HIV-1 in the immunized individuals. To describe the effects of this immunization on general immunological, virological and clinical parameters. To evaluate the safety of injecting recombinant gp160 in this population. To evaluate the extent of variability between different lots of gp160 (arms C1 and C2). It might be possible to increase immune responses or to induce new types of immune responses to HIV in some infected individuals by means of a vaccine, which could result in an immunological, virological or clinical benefit.
Detailed description
It might be possible to increase immune responses or to induce new types of immune responses to HIV in some infected individuals by means of a vaccine, which could result in an immunological, virological or clinical benefit.
ORIGINAL DESIGN: Patients are randomized to one of five groups to receive, intramuscularly, one of four dosages of gp160 or hepatitis B vaccine as a control. Treatments are given at 0, 1, 3, 6, 9, and 12 months and patients are followed for up to 2 years. Patients in any of the 5 groups will have the option of switching to another dosage group if an interim analysis at 6 months shows significant differences in patient response. AMENDED: 10/23/90 52 eligible patients are randomized to one of 6 study groups. Five groups of 8 individuals receive one of 4 dosage levels of gp160 (Groups A, B, C1, C2, and D), and 12 patients receive a single dosage level of hepatitis B vaccine as a control (Group E). Per 2/19/92 amendment, patients may elect to continue receiving vaccine beyond 12 months, with the doses given either every 3 months or every 6 months.
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 (6 listed)
- Acute use (< 14 days) of acyclovir for Herpes simplex virus infection or ketoconazole for symptomatic Candida infections.
- An additional group of up to 20 patients may be added to the study. Patients from ACTG 148 with a repeatedly negative delayed-type hypersensitivity (DTH) reaction who have reached their third dose of ID gp160 at 32 mcg and have failed to develop new proliferative response have the option, after a 2-month interval, to enter this protocol.
- They must meet inclusion and exclusion criteria that apply to this protocol.
- Patients with CD4 counts of 400 - 500 cells/mm3 must be informed of the recommended zidovudine (AZT) therapy and sign an informed consent statement declining AZT therapy.
Key exclusion criteria (22 listed)
- Fever of > 100 degrees F persisting for > 15 days in a 30-day interval without definable cause.
- Recurrent oral candidiasis.
- Multidermatomal herpes zoster.
- Biopsy-proven hairy leukoplakia.
- Fatigue/malaise of > 1 month duration that interferes with normal activities.
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 |
|---|---|---|
| gp160 Vaccine (MicroGeneSys) | Biological | – |
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 10634195Katzenstein DA, Kundu S, Spritzler J, Smoller BR, Haszlett P, Valentine F, Merigan TC. Delayed-type hypersensitivity to recombinant HIV envelope glycoprotein (rgp160) after immunization with homologous antigen. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):341-7. doi: 10.1097/00126334-199912010-00004.
- Background: PubMed 9292585Kundu SK, Katzenstein D, Valentine FT, Spino C, Efron B, Merigan TC. Effect of therapeutic immunization with recombinant gp160 HIV-1 vaccine on HIV-1 proviral DNA and plasma RNA: relationship to cellular immune responses. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Aug 1;15(4):269-74. doi: 10.1097/00042560-199708010-00004.
- BackgroundValentine F, et al. A randomized, controlled study of immunogenicity of rgp160 vaccine in HIV-infected subjects. Int Conf AIDS. 1992 Jul 19-24;8(1):Tu39 (abstract no TuB 0561)
- Background: PubMed 8648205Valentine FT, Kundu S, Haslett PA, Katzenstein D, Beckett L, Spino C, Borucki M, Vasquez M, Smith G, Korvick J, Kagan J, Merigan TC. A randomized, placebo-controlled study of the immunogenicity of human immunodeficiency virus (HIV) rgp160 vaccine in HIV-infected subjects with > or = 400/mm3 CD4 T lymphocytes (AIDS Clinical Trials Group Protocol 137). J Infect Dis. 1996 Jun;173(6):1336-46. doi: 10.1093/infdis/173.6.1336.
- Background: PubMed 1360665Kundu SK, Katzenstein D, Moses LE, Merigan TC. Enhancement of human immunodeficiency virus (HIV)-specific CD4+ and CD8+ cytotoxic T-lymphocyte activities in HIV-infected asymptomatic patients given recombinant gp160 vaccine. Proc Natl Acad Sci U S A. 1992 Dec 1;89(23):11204-8. doi: 10.1073/pnas.89.23.11204.
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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.
Valentine F study chair
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gp160 Vaccine (MicroGeneSys) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites 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 6 inclusion and 22 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 2 sites 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 NCT00000977, which also lists 5 linked publications.
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.