HIV InfectionsNCT00000930
A Study of HIV in Newly Infected Individuals
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 12 sites in United States.
Trial summary
The purpose of this study is to see how HIV reacts in the immune systems of patients who have recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs in newly infected patients. Certain populations are good candidates for participation in HIV vaccine trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- Not given
- Where
- 12 sitesUnited States
- Study dates
- Start not givento May 2008
- 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
- Patients must have:
- HIV infection, as documented by enrollment in HIVNET D01.1 (Part A patients) or by standard HIV serological tests or demonstrated HIV infection on virologic assay (Part B patients).
- Part A only:
- Previous enrollment in infected-participants cohort of HIVNET D01.
- Part B only:
- Initial HIV-seronegativity on an HIVNET protocol (other than an HIV vaccine protocol) and testing positive for HIV at a subsequent clinic visit.
- Confirmation of HIV infection and documentation of HIV negative antibody test within 8 months of first positive test.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions are excluded:
- An obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the study.
- Prior Medication:
- Excluded:
- Participation in a HIVNET HIV vaccine trial.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Johns Hopkins Univ
Baltimore, Maryland, 21205
Fenway Community Health Ctr / HIVNET
Boston, Massachusetts, 02115
Univ of Illinois Chicago / Howard Brown Hlth Ctr
Chicago, Illinois, 60612
Denver Dept of Public Health / HIVNET
Denver, Colorado, 80204
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, 90033
New York Univ Med Ctr
New York, New York, 10016
Univ of Pennsylvania / HIVNET
Philadelphia, Pennsylvania, 19104
Miriam Hosp
Providence, Rhode Island, 02906
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102
Univ of Washington
Seattle, Washington, 98104
Bronx-Lebanon Hosp Ctr
The Bronx, New York, 10453
New York Blood Ctr
The Bronx, New York, 10456
About this study
Official title: Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations
The purpose of this study is to see how HIV reacts in the immune systems of patients who have recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs in newly infected patients.
Certain populations are good candidates for participation in HIV vaccine trials. These groups include men who have sex with men, IV drug users, and women at risk of getting HIV through heterosexual contact. Learning how HIV behaves in these populations once they become infected can help with the planning of future HIV vaccine studies.
Read the detailed description
This study provides an opportunity to prospectively monitor markers of HIV infection and disease progression in cohorts suitable for HIV vaccine trials. The detection of changes in HIV phenotype and genotype, clinical progression rates, and antiretroviral resistance within study populations over time are important for planning future HIV vaccine trials.
This study consists of two parts. Part A includes HIV-infected patients who enrolled in HIVNET D01.1 (infected-participants cohort of HIVNET D01) and whose HIV disease has been closely monitored and characterized. This study continues to monitor these patients with follow-up evaluations every 3 months for the first 18 months and then every 6 months thereafter. Part B includes newly HIV-infected patients. These patients are monitored with clinical and laboratory evaluations at 0, 1, 3, 6, 9, 12, and 18 months, and then every 6 months through Year 5.
- Conditions
- HIV Infections
- Keywords
- Sexual Partners, Drug Resistance, Microbial, Cohort Studies, Risk Factors, Substance Abuse, Intravenous, Disease Progression, Homosexuality, Male, Genotype, Phenotype
- Medical subject headings
- HIV Infections, Substance Abuse, Intravenous, Disease Progression, Homosexuality, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | HIV-infected individuals enrolled in HIVNET D01 | |
| B | Individuals with newly acquired HIV infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of changes in HIV phenotype and genotype
Measured: Throughout study
Clinical progression rates
Measured: Throughout study
Antiviral resistance
Measured: Throughout study
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 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Celum C, Study chairBuchbinder S, Study chairSheppard H, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000930
- Sponsor's protocol ID
- HIVNET 019
- Status last verified
- Oct 2012
- First submitted
- 2 Nov 1999
- Last updated
- 7 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infected Participants Protocol: Evaluation of Natural History of HIV Infection in Newly HIV-Infected Persons in HIVNET Target Populations
- ClinicalTrials.gov ID
- NCT00000930
- Acronym / sponsor ID
- HIVNET 019
- Conditions
- HIV Infections
- Keywords
- Sexual Partners, Drug Resistance, Microbial, Cohort Studies, Risk Factors, Substance Abuse, Intravenous, Disease Progression, Homosexuality, Male, Genotype
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (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 see how HIV reacts in the immune systems of patients who have recently been infected with HIV. This study also examines HIV's resistance to anti-HIV drugs in newly infected patients.
Certain populations are good candidates for participation in HIV vaccine trials. These groups include men who have sex with men, IV drug users, and women at risk of getting HIV through heterosexual contact. Learning how HIV behaves in these populations once they become infected can help with the planning of future HIV vaccine studies.
Detailed description
This study provides an opportunity to prospectively monitor markers of HIV infection and disease progression in cohorts suitable for HIV vaccine trials. The detection of changes in HIV phenotype and genotype, clinical progression rates, and antiretroviral resistance within study populations over time are important for planning future HIV vaccine trials.
This study consists of two parts. Part A includes HIV-infected patients who enrolled in HIVNET D01.1 (infected-participants cohort of HIVNET D01) and whose HIV disease has been closely monitored and characterized. This study continues to monitor these patients with follow-up evaluations every 3 months for the first 18 months and then every 6 months thereafter. Part B includes newly HIV-infected patients. These patients are monitored with clinical and laboratory evaluations at 0, 1, 3, 6, 9, 12, and 18 months, and then every 6 months through Year 5.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –HIV-infected individuals enrolled in HIVNET D01 |
| B | – | –Individuals with newly acquired HIV infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV infection, as documented by enrollment in HIVNET D01.1 (Part A patients) or by standard HIV serological tests or demonstrated HIV infection on virologic assay (Part B patients).
- Previous enrollment in infected-participants cohort of HIVNET D01.
- Initial HIV-seronegativity on an HIVNET protocol (other than an HIV vaccine protocol) and testing positive for HIV at a subsequent clinic visit.
- Confirmation of HIV infection and documentation of HIV negative antibody test within 8 months of first positive test.
Key exclusion criteria (6 listed)
- An obvious psychological/psychiatric disorder that would invalidate the informed consent process or otherwise contraindicate participation in the study.
- Participation in a HIVNET HIV vaccine trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of changes in HIV phenotype and genotype
Time frame: Throughout study
Clinical progression rates
Time frame: Throughout study
Antiviral resistance
Time frame: Throughout study
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 7 Nov 2016.
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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.
Celum C study chair
Buchbinder S study chair
Sheppard H study chair
12 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 12 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 7 inclusion and 6 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 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
What does the primary outcome measure?
Detection of changes in HIV phenotype and genotype (time frame: Throughout study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2016.