HIV InfectionsPhase 1NCT00000755
A Phase I/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3
A Phase 1 study testing rgp120/HIV-1MN and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial summary
To examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen. To determine the effect of antiretroviral therapy on vaccine responsiveness. Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- rgp120/HIV-1MN and Zidovudine
- How many people
- 168 participants
- Where
- 10 sitesUnited States
- Study dates
- Start not givento Mar 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Required immediately prior to study entry:
- A minimum of 2 and a maximum of 12 months of AZT therapy at 500-600 mg/day (does not apply to the pilot group patients receiving vaccine only and to patients with CD4 counts of 50-199 cells/mm3).
- Concurrent Medication:
- Allowed:
- PCP prophylaxis.
- Rifabutin and clarithromycin (in patients with CD4 counts of 50-199 cells/mm3 only).
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- Short-term nonsteroidal anti-inflammatory therapy for acute conditions.
- Short intermittent cycles of acyclovir.
- Patients must have:
- HIV infection, with CD4 count of 50-500 cells/mm3.
- No active opportunistic infection (patients with CD4 counts of 50-199 cells/mm3 may have a history of an opportunistic infection).
- Consent of parent, guardian, or person with power of attorney, if less than 18 years of age.
- B-cell lines established in order to be vaccinated.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known or suspected allergies to any vaccine components.
- Concurrent Medication:
- Excluded:
- Agents with immunosuppressive activity.
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- Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-199 cells/mm3).
- Interferon.
- Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma).
- Steroids.
- Hematopoietins.
- Prior Medication:
- Excluded within 12 weeks prior to study entry:
- Agents with immunosuppressive activity.
- Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-349 cells/mm3).
- Interferon.
- Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma).
- Steroids.
- Hematopoietins.
- Active drug abuse.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Colorado Hospital CRS
Aurora, Colorado, 80262
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114
Bmc Actg Crs
Boston, Massachusetts, 02118
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215
UCLA CARE Center CRS
Los Angeles, California, 90095
NY Univ. HIV/AIDS CRS
New York, New York, 10016
Stanford CRS
Palo Alto, California, 943055107
Ucsf Aids Crs
San Francisco, California, 941102859
University of Washington AIDS CRS
Seattle, Washington, 981224304
About this study
To examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen. To determine the effect of antiretroviral therapy on vaccine responsiveness.
Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.
Read the detailed description
Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.
Patients are randomized to receive rgp120/HIV-1MN vaccine or alum adjuvant placebo by intramuscular injection at weeks 0, 4, 8, 12, 16, and 20, with or without daily oral zidovudine (AZT) or their current stable dose of antiretroviral therapy. After completing the primary vaccination series, patients are permitted to continue into an extension phase, in which they receive a booster vaccination at weeks 28, 36, and 44. Patients will be stratified by CD4 count: 350-500, 200-349, and 50-199 cells/mm3. A fourth group with counts of 350-500 cells/mm3 will serve as a pilot group and receive vaccine only.
- Conditions
- HIV Infections
- Being tested
- rgp120/HIV-1MN, Zidovudine
- Keywords
- Vaccines, Synthetic, HIV-1, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rgp120/HIV-1MNBiological
ZidovudineDrug
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 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Prevention
- Intervention model
- Parallel groups
- Enrolment
- 168 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Genentech, Inc., Glaxo Wellcome
- Responsible party
- Sponsor
- Investigators
- Schooley RT, Study chairWalker B, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000755
- Sponsor's protocol ID
- ACTG 209
- Other IDs
- 11186
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 4 Nov 2021
- Results posted
- No
Publications
Kuritzkes DR, Spino C, Valentine F, Schooley RT. Association of plasma HIV-1 RNA, CD4 count, and immune response in patients with 50-500 CD4 cells/ul. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:204 (abstract no 757)
Schooley RT, Spino C, Chiu S, DeGruttola V, Kuritzkes DR. Poor immunogenicity of HIV-1 envelope vaccines with alum or MF59 aduvant in HIV-infected individuals: results of two randomized trials. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:204 (abstract no 756)
Schooley RT, Spino C, Kuritzkes D, Walker BD, Valentine FA, Hirsch MS, Cooney E, Friedland G, Kundu S, Merigan TC Jr, McElrath MJ, Collier A, Plaeger S, Mitsuyasu R, Kahn J, Haslett P, Uherova P, deGruttola V, Chiu S, Zhang B, Jones G, Bell D, Ketter N, Twadell T, Chernoff D, Rosandich M. Two double-blinded, randomized, comparative trials of 4 human immunodeficiency virus type 1 (HIV-1) envelope vaccines in HIV-1-infected individuals across a spectrum of disease severity: AIDS Clinical Trials Groups 209 and 214. J Infect Dis. 2000 Nov;182(5):1357-64. doi: 10.1086/315860. Epub 2000 Oct 9.
PubMed 11023459
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/II Trial of Vaccine Therapy of HIV-1 Infected Individuals With 50-500 CD4 Cells/mm3
- ClinicalTrials.gov ID
- NCT00000755
- Acronym / sponsor ID
- ACTG 209
- Conditions
- HIV Infections
- Keywords
- Vaccines, Synthetic, HIV-1, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Genentech, Inc., Glaxo Wellcome
- Study completion
- Mar 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 examine the response of HIV-1 infected patients to vaccination with gp120/HIV-1MN antigen. To determine the effect of antiretroviral therapy on vaccine responsiveness.
Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.
Detailed description
Fifty percent of HIV-1 infected individuals remain symptom free for 8-12 years. It has been hypothesized that HIV-specific immune responses are responsible for the period of relative quiescence of viral replication. Recent studies suggest that these immune functions can be augmented by vaccination with HIV-derived antigens.
Patients are randomized to receive rgp120/HIV-1MN vaccine or alum adjuvant placebo by intramuscular injection at weeks 0, 4, 8, 12, 16, and 20, with or without daily oral zidovudine (AZT) or their current stable dose of antiretroviral therapy. After completing the primary vaccination series, patients are permitted to continue into an extension phase, in which they receive a booster vaccination at weeks 28, 36, and 44. Patients will be stratified by CD4 count: 350-500, 200-349, and 50-199 cells/mm3. A fourth group with counts of 350-500 cells/mm3 will serve as a pilot group and receive vaccine only.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- A minimum of 2 and a maximum of 12 months of AZT therapy at 500-600 mg/day (does not apply to the pilot group patients receiving vaccine only and to patients with CD4 counts of 50-199 cells/mm3).
- PCP prophylaxis.
- Rifabutin and clarithromycin (in patients with CD4 counts of 50-199 cells/mm3 only).
- Short-term nonsteroidal anti-inflammatory therapy for acute conditions.
- Short intermittent cycles of acyclovir.
Key exclusion criteria (20 listed)
- Known or suspected allergies to any vaccine components.
- Agents with immunosuppressive activity.
- Antiretroviral therapies other than AZT (except in patients with CD4 counts of 50-199 cells/mm3).
- Interferon.
- Parenteral therapies (including SC allergy medications and chemotherapy for Kaposi's sarcoma).
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 |
|---|---|---|
| rgp120/HIV-1MN | Biological | – |
| Zidovudine | 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.
- BackgroundKuritzkes DR, Spino C, Valentine F, Schooley RT. Association of plasma HIV-1 RNA, CD4 count, and immune response in patients with 50-500 CD4 cells/ul. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:204 (abstract no 757)
- BackgroundSchooley RT, Spino C, Chiu S, DeGruttola V, Kuritzkes DR. Poor immunogenicity of HIV-1 envelope vaccines with alum or MF59 aduvant in HIV-infected individuals: results of two randomized trials. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:204 (abstract no 756)
- Background: PubMed 11023459Schooley RT, Spino C, Kuritzkes D, Walker BD, Valentine FA, Hirsch MS, Cooney E, Friedland G, Kundu S, Merigan TC Jr, McElrath MJ, Collier A, Plaeger S, Mitsuyasu R, Kahn J, Haslett P, Uherova P, deGruttola V, Chiu S, Zhang B, Jones G, Bell D, Ketter N, Twadell T, Chernoff D, Rosandich M. Two double-blinded, randomized, comparative trials of 4 human immunodeficiency virus type 1 (HIV-1) envelope vaccines in HIV-1-infected individuals across a spectrum of disease severity: AIDS Clinical Trials Groups 209 and 214. J Infect Dis. 2000 Nov;182(5):1357-64. doi: 10.1086/315860. Epub 2000 Oct 9.
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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.
Schooley RT study chair
Walker B study chair
10 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 rgp120/HIV-1MN and Zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 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 13 inclusion and 20 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 10 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 NCT00000755, which also lists 3 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.