HIV InfectionsNCT00001078
A Study on the Rate of Opportunistic (AIDS-Related) Infections Among HIV-Positive Children Who Have Stopped Taking Their OI Preventive Medications
A study testing Hepatitis A Vaccine (Inactivated) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 50 sites in 2 countries.
Trial summary
The purpose of this study is to find out if it is safe for HIV-positive children who are responding well to their anti-HIV treatment to stop taking medications that prevent AIDS-related infections (opportunistic infections) such as pneumonia and other bacterial infections. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Hepatitis A Vaccine (Inactivated)
- Type of treatment
- Vaccines
- How many people
- 200 participants
- Where
- 50 sitesin 2 countries
- Study dates
- Start not givento May 2005
- Phase
- Interventional
- 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 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children may be eligible for this study if they:
- Are HIV-positive.
- Have a CD4 percent greater than or equal to 25 percent if they are under 6 years of age, or have a CD4 percent greater than or equal to 20 percent on 2 occasions if they are between the ages of 6 and 21.
- Have been receiving preventive treatment for PCP for at least 6 months and have not stopped treatment for more than 3 months before study entry.
- Are willing to stop taking preventive treatment for PCP and MAC.
- Have received the same continuous antiretroviral (anti-HIV) therapy for the 16 weeks before beginning the study. (Continuous therapy means missing no more than a total of 3 weeks during the 16 weeks.)
- Are between the ages of 2 and 21 years (consent of parent or guardian is required if under 18).
Who cannot join
- Children will not be eligible for this study if they:
- Have PCP.
- Have any other active infection, such as tuberculosis or toxoplasmosis, or any other significant disease.
- Are receiving chemotherapy for cancer or certain other medications.
Trial locations and contacts
50 sites in 2 countries.
50 sites in 2 countries
United States47 sites
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
Children's Hosp of Boston
Boston, Massachusetts, 021155724
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
SUNY - Brooklyn
Brooklyn, New York, 11203
Med Univ of South Carolina
Charleston, South Carolina, 294253312
Cook County Hosp
Chicago, Illinois, 60612
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
Columbus Children's Hosp
Columbus, Ohio, 432052696
Children's Hosp of Denver
Denver, Colorado, 802181088
Children's Hosp of Michigan
Detroit, Michigan, 48201
Duke Univ Med Ctr
Durham, North Carolina, 277103499
North Shore Univ Hosp
Great Neck, New York, 11021
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
Univ of Miami (Pediatric)
Miami, Florida, 33161
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
Yale Univ Med School
New Haven, Connecticut, 06504
Schneider Children's Hosp
New Hyde Park, New York, 11040
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Metropolitan Hosp Ctr
New York, New York, 10029
Columbia Presbyterian Med Ctr
New York, New York, 10032
Harlem Hosp Ctr
New York, New York, 10037
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
Children's Hosp of Oakland
Oakland, California, 946091809
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
Phoenix Childrens Hosp
Phoenix, Arizona, 85006
Med College of Virginia
Richmond, Virginia, 23219
Palm Beach County Health Dept
Riviera Beach, Florida, 33404
Univ of Rochester Med Ctr
Rochester, New York, 146420001
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
Puerto Rico3 sites
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, 00956
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, 009365067
San Juan City Hosp
San Juan, 009367344
About this study
Official title: An Observational Study of the Rate of Opportunistic Infection Events in HIV-Infected Children Who Have Demonstrated Immunologic Reconstitution and Who Have Discontinued OI Prophylaxis
The purpose of this study is to find out if it is safe for HIV-positive children who are responding well to their anti-HIV treatment to stop taking medications that prevent AIDS-related infections (opportunistic infections) such as pneumonia and other bacterial infections. This is an observational study, meaning children will only be monitored to see if they develop any infections.
Children have been receiving medications to prevent complications of HIV infection, such as Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC) disease, or other bacterial infections. It is common for HIV-positive patients with low CD4 counts to receive these preventive medications. However, these drugs can have serious side effects, they are expensive, and it is possible for bacteria resistant to the drugs to grow. For these reasons, it may be beneficial to the child to stop taking these preventive medications if he/she has been on anti-HIV (antiretroviral) therapy and has improved CD4 counts. This study will look at how many children who stop taking their medications develop opportunistic infections.
Read the detailed description
Due to the strong correlation between a significant decrease in CD4 count and the frequency and magnitude of OIs such as Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC), and severe bacterial infections, CD4 count has become the major criterion for initiating antimicrobial prophylaxis for OIs. However, despite the benefits of these antimicrobial drugs, all are associated with adverse side effects, and patients with reconstituted immune systems following antiretroviral therapy may be receiving prophylaxis unnecessarily. Benefits to stopping prophylaxis include: (1) elimination of adverse effects from drugs; (2) reduction in drug costs; and (3) removal of selective pressure for the development of drug-resistant microbes. These benefits must be weighed against the disadvantages, however, such as more frequent determinations of CD4 counts to assure maintenance of immunocompetence, more frequent occurrence of serious OIs otherwise preventable with prophylaxis in patients lost to follow-up, and possible occurrence of atypical PCP because of prior exposure to anti-PCP drugs. [AS PER AMENDMENT 04/26/02: The extent of complete immune restitution has not yet been defined. An important corollary of an incomplete immune recovery is that vaccination schedules might need to be adjusted to obtain optimal responses in HIV-infected patients on highly active antiretroviral therapy (HAART). Therefore, a third dose of hepatitis A virus vaccine will be administered.]
After pre-entry and entry laboratory studies, patients are followed every 8 weeks until the last patient has completed 104 weeks of study observation. Hepatitis A vaccination is administered at entry and Week 24 to measure responses to neoantigen. [AS PER AMENDMENT 04/26/02: All patients (except those co-enrolled in P1024 on or after November 1, 2001) who have received 2 doses of hepatitis A virus vaccine during the study will be offered an opportunity to enroll in Step II of P1008. Patients in Step II receive a third dose of hepatitis A vaccination at Week 104 or later. Additional blood samples are taken 8 weeks later for antibody detection and peripheral blood mononuclear cell (PBMC) cryopreservation.] All serious bacterial infections that are Grade 3 or higher and OI events are recorded and compared to historical event rates. Virologic and immunologic marker studies are done in all patients and correlated with the risk of developing serious bacterial infections or OI events. Patients are considered to have reached an endpoint if they develop PCP, 2 serious bacterial infections, other Category C OI diagnoses, or CD4% less than 15% and re-initiation of PCP prophylaxis.
- Conditions
- HIV Infections
- Being tested
- Hepatitis A Vaccine (Inactivated)
- Keywords
- Viral Vaccines, AIDS-Related Opportunistic Infections, Anti-HIV Agents, Hepatitis A Virus, Human
- Medical subject headings
- HIV Infections, AIDS-Related Opportunistic Infections, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis A Vaccine (Inactivated)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)
- Primary completionMay 2005
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 N/A
- Primary purpose
- Treatment
- Enrolment
- 200 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Wayne Dankner, Study chairRam Yogev, Study chairWalter Hughes, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001078
- Sponsor's protocol ID
- ACTG P1008
- Other IDs
- PACTG P1008
- Status last verified
- Jul 2005
- First submitted
- 2 Nov 1999
- Last updated
- 2 Mar 2011
- Results posted
- No
Publications
Weinberg A, Huang S, Fenton T, Patterson-Bartlett J, Gona P, Read JS, Dankner WM, Nachman S; IMPAACT P1008 Team. Virologic and immunologic correlates with the magnitude of antibody responses to the hepatitis A vaccine in HIV-infected children on highly active antiretroviral treatment. J Acquir Immune Defic Syndr. 2009 Sep 1;52(1):17-24. doi: 10.1097/QAI.0b013e3181b011f6.
PubMed 19617848
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Rate of Opportunistic Infection Events in HIV-Infected Children Who Have Demonstrated Immunologic Reconstitution and Who Have Discontinued OI Prophylaxis
- ClinicalTrials.gov ID
- NCT00001078
- Acronym / sponsor ID
- ACTG P1008
- Conditions
- HIV Infections
- Keywords
- Viral Vaccines, AIDS-Related Opportunistic Infections, Anti-HIV Agents, Hepatitis A Virus, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Primary completion
- May 2005 (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.
The purpose of this study is to find out if it is safe for HIV-positive children who are responding well to their anti-HIV treatment to stop taking medications that prevent AIDS-related infections (opportunistic infections) such as pneumonia and other bacterial infections. This is an observational study, meaning children will only be monitored to see if they develop any infections.
Children have been receiving medications to prevent complications of HIV infection, such as Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC) disease, or other bacterial infections. It is common for HIV-positive patients with low CD4 counts to receive these preventive medications. However, these drugs can have serious side effects, they are expensive, and it is possible for bacteria resistant to the drugs to grow. For these reasons, it may be beneficial to the child to stop taking these preventive medications if he/she has been on anti-HIV (antiretroviral) therapy and has improved CD4 counts. This study will look at how many children who stop taking their medications develop opportunistic infections.
Detailed description
Due to the strong correlation between a significant decrease in CD4 count and the frequency and magnitude of OIs such as Pneumocystis carinii pneumonia (PCP), Mycobacterium avium complex (MAC), and severe bacterial infections, CD4 count has become the major criterion for initiating antimicrobial prophylaxis for OIs. However, despite the benefits of these antimicrobial drugs, all are associated with adverse side effects, and patients with reconstituted immune systems following antiretroviral therapy may be receiving prophylaxis unnecessarily. Benefits to stopping prophylaxis include: (1) elimination of adverse effects from drugs; (2) reduction in drug costs; and (3) removal of selective pressure for the development of drug-resistant microbes. These benefits must be weighed against the disadvantages, however, such as more frequent determinations of CD4 counts to assure maintenance of immunocompetence, more frequent occurrence of serious OIs otherwise preventable with prophylaxis in patients lost to follow-up, and possible occurrence of atypical PCP because of prior exposure to anti-PCP drugs. [AS PER AMENDMENT 04/26/02: The extent of complete immune restitution has not yet been defined. An important corollary of an incomplete immune recovery is that vaccination schedules might need to be adjusted to obtain optimal responses in HIV-infected patients on highly active antiretroviral therapy (HAART). Therefore, a third dose of hepatitis A virus vaccine will be administered.]
After pre-entry and entry laboratory studies, patients are followed every 8 weeks until the last patient has completed 104 weeks of study observation. Hepatitis A vaccination is administered at entry and Week 24 to measure responses to neoantigen. [AS PER AMENDMENT 04/26/02: All patients (except those co-enrolled in P1024 on or after November 1, 2001) who have received 2 doses of hepatitis A virus vaccine during the study will be offered an opportunity to enroll in Step II of P1008. Patients in Step II receive a third dose of hepatitis A vaccination at Week 104 or later. Additional blood samples are taken 8 weeks later for antibody detection and peripheral blood mononuclear cell (PBMC) cryopreservation.] All serious bacterial infections that are Grade 3 or higher and OI events are recorded and compared to historical event rates. Virologic and immunologic marker studies are done in all patients and correlated with the risk of developing serious bacterial infections or OI events. Patients are considered to have reached an endpoint if they develop PCP, 2 serious bacterial infections, other Category C OI diagnoses, or CD4% less than 15% and re-initiation of PCP prophylaxis.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Are HIV-positive.
- Have a CD4 percent greater than or equal to 25 percent if they are under 6 years of age, or have a CD4 percent greater than or equal to 20 percent on 2 occasions if they are between the ages of 6 and 21.
- Have been receiving preventive treatment for PCP for at least 6 months and have not stopped treatment for more than 3 months before study entry.
- Are willing to stop taking preventive treatment for PCP and MAC.
- Have received the same continuous antiretroviral (anti-HIV) therapy for the 16 weeks before beginning the study. (Continuous therapy means missing no more than a total of 3 weeks during the 16 weeks.)
Key exclusion criteria (4 listed)
- Have PCP.
- Have any other active infection, such as tuberculosis or toxoplasmosis, or any other significant disease.
- Are receiving chemotherapy for cancer or certain other medications.
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 |
|---|---|---|
| Hepatitis A Vaccine (Inactivated) | 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 2 Mar 2011.
- Results publication: PubMed 19617848Weinberg A, Huang S, Fenton T, Patterson-Bartlett J, Gona P, Read JS, Dankner WM, Nachman S; IMPAACT P1008 Team. Virologic and immunologic correlates with the magnitude of antibody responses to the hepatitis A vaccine in HIV-infected children on highly active antiretroviral treatment. J Acquir Immune Defic Syndr. 2009 Sep 1;52(1):17-24. doi: 10.1097/QAI.0b013e3181b011f6.
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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.
Wayne Dankner study chair
Ram Yogev study chair
Walter Hughes study chair
50 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatitis A Vaccine (Inactivated) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 50 sites in 2 countries.
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 7 inclusion and 4 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 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Puerto Rico. 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 NCT00001078, 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 2 Mar 2011.