HIV InfectionsNCT00050063
Effects of Therapeutic HIV Vaccination on Control of HIV After Discontinuation of Anti-HIV Drugs
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 sites in United States.
Trial summary
The purpose of this study is to determine whether therapeutic HIV vaccines can help the immune system control HIV viral load after anti-HIV drugs are discontinued. 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?
- Therapeutic vaccinations from A5058s
- Type of treatment
- Vaccines
- How many people
- 78 participants
- Where
- 14 sitesUnited States
- Study dates
- Start not givento May 2004
- Phase
- Observational
- 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
- Participation in A5058s and receipt of a minimum of 7 sets of injections on that study
- Continuation of the same stable antiretroviral treatment that was given in A5058s for the last 3 months prior to A5172 entry, unless the regimen was changed for toxicity in the absence of virologic failure
- No less than 6 weeks and no more than 18 weeks since the last injection on A5058s prior to A5172 entry
- CD4+ T-cell count > 300 cells/mm3 obtained within 30 days prior to study entry
- HIV-1 RNA < 500 copies/ml obtained within 30 days prior to study entry
- Agreement to use approved methods of contraception
Who cannot join
- Pregnancy or breast-feeding
- Any of the following within 30 days prior to entry: acute infection requiring antibiotics, outbreak of herpes simplex virus (HSV) or herpes zoster, other acute medical illness, or surgery
- Symptomatic chronic infections other than HIV
- Malignancy that may require systemic therapy
- History of lymph node irradiation
- Use of immunoenhancing or immunosuppressive drugs within 30 days prior to entry, or any underlying disease of sufficient severity that these excluded drugs may be prescribed
Show all 10Show fewer
- Hydroxyurea within 30 days prior to study entry
- Use of GM-CSF, G-CSF, M-CSF, IFN, IL-2, or other cytokines within 30 days prior to study entry
- Active drug or alcohol use or dependence that would interfere with adherence to study requirements
- Serious illness requiring systemic treatment and/or hospitalization until patient either completes therapy or is clinically stable on therapy for at least 30 days prior to study entry
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 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 Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, 02215
Unc Aids Crs
Chapel Hill, North Carolina, 27514
Case CRS
Cleveland, Ohio, 44106-5083
Univ. of Texas Medical Branch, ACTU
Galveston, Texas, 77555
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, 46202
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202
Beth Israel Med. Ctr., ACTU
New York, New York, 10003
NY Univ. HIV/AIDS CRS
New York, New York, 10016-6481
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502-2052
About this study
Official title: A Rollover Study of A5058s: A Phase II Trial to Evaluate the Ability of Vaccine-Induced Helper and CTL Responses to Control Viremia in the Absence of Antiretroviral Therapy
The purpose of this study is to determine whether therapeutic HIV vaccines can help the immune system control HIV viral load after anti-HIV drugs are discontinued.
Read the detailed description
This study is a rollover study for patients who participated in A5058s: Augmentation of HIV-Specific Helper and CTL Responses Through Therapeutic Vaccination in Individuals Receiving Potent Suppressive Antiretroviral Therapies. In A5058s, patients received a series of therapeutic vaccinations to elicit HIV-specific immune responses. This study will examine whether these vaccine-induced responses can control viral load in the absence of antiretroviral therapy (ART).
Upon study entry, patients will discontinue ART. During the first 6 weeks of the study, viral load will be monitored weekly and CD4+ T-cell counts will be monitored every other week. Viral load and CD4+ T-cell counts will be measured every other week from Week 6 through Week 24, then monthly until patients restart ART or until Week 48. Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 10 weeks.
- Conditions
- HIV Infections
- Being tested
- Therapeutic vaccinations from A5058s
- Keywords
- HIV Therapeutic Vaccine, Treatment Experienced, AIDS Vaccines, Treatment Interruption, Viral Load, T-Lymphocytes, Cytotoxic, T-Lymphocytes, Helper-Inducer
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic vaccinations from A5058sBiological
Participants will receive assigned interventions assigned in study A5058s.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2002 (estimated)
- Study completionMay 2004
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 78 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Spyros Kalamus, M. D., Study chair, Vanderbilt University Medical CenterFred Valentine, M. D., Study chair, NYU MEDICAL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050063
- Sponsor's protocol ID
- A5172
- Other IDs
- 10184, ACTG A5172
- Status last verified
- Oct 2021
- First submitted
- 20 Nov 2002
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Papasavvas E, Ortiz GM, Gross R, Sun J, Moore EC, Heymann JJ, Moonis M, Sandberg JK, Drohan LA, Gallagher B, Shull J, Nixon DF, Kostman JR, Montaner LJ. Enhancement of human immunodeficiency virus type 1-specific CD4 and CD8 T cell responses in chronically infected persons after temporary treatment interruption. J Infect Dis. 2000 Sep;182(3):766-75. doi: 10.1086/315748. Epub 2000 Aug 17.
PubMed 10950770Carcelain G, Tubiana R, Samri A, Calvez V, Delaugerre C, Agut H, Katlama C, Autran B. Transient mobilization of human immunodeficiency virus (HIV)-specific CD4 T-helper cells fails to control virus rebounds during intermittent antiretroviral therapy in chronic HIV type 1 infection. J Virol. 2001 Jan;75(1):234-41. doi: 10.1128/JVI.75.1.234-241.2001.
PubMed 11119593Deeks SG, Wrin T, Liegler T, Hoh R, Hayden M, Barbour JD, Hellmann NS, Petropoulos CJ, McCune JM, Hellerstein MK, Grant RM. Virologic and immunologic consequences of discontinuing combination antiretroviral-drug therapy in HIV-infected patients with detectable viremia. N Engl J Med. 2001 Feb 15;344(7):472-80. doi: 10.1056/NEJM200102153440702.
PubMed 11172188Ruiz L, Carcelain G, Martinez-Picado J, Frost S, Marfil S, Paredes R, Romeu J, Ferrer E, Morales-Lopetegi K, Autran B, Clotet B. HIV dynamics and T-cell immunity after three structured treatment interruptions in chronic HIV-1 infection. AIDS. 2001 Jun 15;15(9):F19-27. doi: 10.1097/00002030-200106150-00001.
PubMed 11416734Garcia F, Plana M, Vidal C, Cruceta A, O'Brien WA, Pantaleo G, Pumarola T, Gallart T, Miro JM, Gatell JM. Dynamics of viral load rebound and immunological changes after stopping effective antiretroviral therapy. AIDS. 1999 Jul 30;13(11):F79-86. doi: 10.1097/00002030-199907300-00002.
PubMed 10449278
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rollover Study of A5058s: A Phase II Trial to Evaluate the Ability of Vaccine-Induced Helper and CTL Responses to Control Viremia in the Absence of Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00050063
- Acronym / sponsor ID
- A5172
- Conditions
- HIV Infections
- Keywords
- HIV Therapeutic Vaccine, Treatment Experienced, AIDS Vaccines, Treatment Interruption, Viral Load, T-Lymphocytes, Cytotoxic, T-Lymphocytes, Helper-Inducer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 2004 (actual)
- First posted
- 21 Nov 2002 (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.
The purpose of this study is to determine whether therapeutic HIV vaccines can help the immune system control HIV viral load after anti-HIV drugs are discontinued.
Detailed description
This study is a rollover study for patients who participated in A5058s: Augmentation of HIV-Specific Helper and CTL Responses Through Therapeutic Vaccination in Individuals Receiving Potent Suppressive Antiretroviral Therapies. In A5058s, patients received a series of therapeutic vaccinations to elicit HIV-specific immune responses. This study will examine whether these vaccine-induced responses can control viral load in the absence of antiretroviral therapy (ART).
Upon study entry, patients will discontinue ART. During the first 6 weeks of the study, viral load will be monitored weekly and CD4+ T-cell counts will be monitored every other week. Viral load and CD4+ T-cell counts will be measured every other week from Week 6 through Week 24, then monthly until patients restart ART or until Week 48. Patients who reinitiate ART for any reason will be registered to Step 2 and followed for 10 weeks.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participation in A5058s and receipt of a minimum of 7 sets of injections on that study
- Continuation of the same stable antiretroviral treatment that was given in A5058s for the last 3 months prior to A5172 entry, unless the regimen was changed for toxicity in the absence of virologic failure
- No less than 6 weeks and no more than 18 weeks since the last injection on A5058s prior to A5172 entry
- CD4+ T-cell count > 300 cells/mm3 obtained within 30 days prior to study entry
- HIV-1 RNA < 500 copies/ml obtained within 30 days prior to study entry
Key exclusion criteria (10 listed)
- Pregnancy or breast-feeding
- Any of the following within 30 days prior to entry: acute infection requiring antibiotics, outbreak of herpes simplex virus (HSV) or herpes zoster, other acute medical illness, or surgery
- Symptomatic chronic infections other than HIV
- Malignancy that may require systemic therapy
- History of lymph node irradiation
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 |
|---|---|---|
| Therapeutic vaccinations from A5058sParticipants will receive assigned interventions assigned in study A5058s. | 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 1 Nov 2021.
- Background: PubMed 10950770Papasavvas E, Ortiz GM, Gross R, Sun J, Moore EC, Heymann JJ, Moonis M, Sandberg JK, Drohan LA, Gallagher B, Shull J, Nixon DF, Kostman JR, Montaner LJ. Enhancement of human immunodeficiency virus type 1-specific CD4 and CD8 T cell responses in chronically infected persons after temporary treatment interruption. J Infect Dis. 2000 Sep;182(3):766-75. doi: 10.1086/315748. Epub 2000 Aug 17.
- Background: PubMed 11119593Carcelain G, Tubiana R, Samri A, Calvez V, Delaugerre C, Agut H, Katlama C, Autran B. Transient mobilization of human immunodeficiency virus (HIV)-specific CD4 T-helper cells fails to control virus rebounds during intermittent antiretroviral therapy in chronic HIV type 1 infection. J Virol. 2001 Jan;75(1):234-41. doi: 10.1128/JVI.75.1.234-241.2001.
- Background: PubMed 11172188Deeks SG, Wrin T, Liegler T, Hoh R, Hayden M, Barbour JD, Hellmann NS, Petropoulos CJ, McCune JM, Hellerstein MK, Grant RM. Virologic and immunologic consequences of discontinuing combination antiretroviral-drug therapy in HIV-infected patients with detectable viremia. N Engl J Med. 2001 Feb 15;344(7):472-80. doi: 10.1056/NEJM200102153440702.
- Background: PubMed 11416734Ruiz L, Carcelain G, Martinez-Picado J, Frost S, Marfil S, Paredes R, Romeu J, Ferrer E, Morales-Lopetegi K, Autran B, Clotet B. HIV dynamics and T-cell immunity after three structured treatment interruptions in chronic HIV-1 infection. AIDS. 2001 Jun 15;15(9):F19-27. doi: 10.1097/00002030-200106150-00001.
- Background: PubMed 10449278Garcia F, Plana M, Vidal C, Cruceta A, O'Brien WA, Pantaleo G, Pumarola T, Gallart T, Miro JM, Gatell JM. Dynamics of viral load rebound and immunological changes after stopping effective antiretroviral therapy. AIDS. 1999 Jul 30;13(11):F79-86. doi: 10.1097/00002030-199907300-00002.
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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.
Spyros Kalamus, M. D. study chair
Vanderbilt University Medical Center
Fred Valentine, M. D. study chair
NYU MEDICAL CENTER
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 14 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 10 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 1 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 14 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.
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 NCT00050063, 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 1 Nov 2021.