HIV InfectionsPhase 1NCT00004736
Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients With Tuberculosis
A Phase 1 study testing Nelfinavir mesylate, Ethambutol hydrochloride and Isoniazid in people with HIV Infections and Tuberculosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial summary
The purpose of this study is to see if a type of anti-HIV therapy called HAART is effective in lowering levels of HIV and boosting the immune system in HIV-infected patients with tuberculosis (TB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- Nelfinavir mesylate, Ethambutol hydrochloride and Isoniazid
- How many people
- 44 participants
- Where
- 10 sitesUnited States
- Study dates
- Start not givento not given
- 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
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Have an HIV RNA level of 20,000 copies/ml or more within 30 days of study entry.
- Are at least 18 years old.
- Agree to use an effective method of birth control during the study.
- Agree to be treated with rifabutin at least 2 weeks before starting HAART (applies only to patients infected with TB).
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- Plan to start HAART within 6 months of starting TB therapy (applies only to patients infected with TB).
- Can take 3TC, nelfinavir, and either ZDV or d4T.
- Are available for follow-up for at least 1 year.
Who cannot join
- Patients will not be eligible for this study if they:
- Have taken a combination of anti-HIV drugs for greater than 3 months.
- Have started HAART since they were infected with TB (applies only to patients infected with TB).
- Are resistant to more than one medication used to treat TB (applies only to patients infected with TB).
- Have had more than 16 weeks of TB therapy (applies only to patients infected with TB).
- Are taking rifampin to treat TB and cannot switch to rifabutin at least 2 weeks before starting HAART (applies only to patients infected with TB).
- Are pregnant or breast-feeding.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Cook County Hosp
Chicago, Illinois, 60612
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
Beth Israel Med Ctr
New York, New York, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
Columbia Presbyterian Med Ctr
New York, New York, 10032
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
About this study
Official title: Viral and Immune Dynamics in HIV-Infected Patients With Tuberculosis
The purpose of this study is to see if a type of anti-HIV therapy called HAART is effective in lowering levels of HIV and boosting the immune system in HIV-infected patients with tuberculosis (TB).
HIV-infected patients with TB have higher levels of HIV and lower CD4 cell counts (cells in the body that fight infection) than HIV-infected patients without TB. HAART has been effective in reducing HIV levels and increasing CD4 cells in patients without TB. However, its effects in HIV-infected patients with TB are unknown.
Read the detailed description
Previous studies have focused on characterizing viral and immune dynamics after initiation of HAART in patients without opportunistic infection. The development of TB in HIV-infected individuals is associated with an elevation in HIV RNA levels, a decrease in CD4 cell counts, and an increase in activated (CD38) lymphocytes and proinflammatory cytokines (IL-1, TNF-alpha, and IL-6). Response to HAART may differ in individuals with an active opportunistic infection such as TB.
HIV-infected patients with active TB follow an anti-TB regimen including rifabutin and are observed for a maximum of 24 weeks before they initiate HAART. Plasma samples for 24-hour post-rifabutin dosing are collected at entry and at Weeks 4, 8, and 12, then again at Weeks 2, 3, 4, 12, and 24 after HAART initiation. Analyses of these samples are used to explore the relationship between cytokines and rifabutin metabolism and the effect of nelfinavir on rifabutin pharmacokinetics. The HAART regimen is nelfinavir plus lamivudine (3TC) plus either zidovudine (ZDV) or stavudine (d4T). After initiation of HAART, all patients undergo intensive monitoring of viral and immune dynamics for 2 months. The patients continue to be followed for 1 year from the time of starting HAART. Neither the HAART drug regimen nor anti-TB medications will be provided by the study and must be obtained by prescription. If patients are intolerant of the HAART regimen or exhibit virologic rebound, primary providers can alter or modify this regimen. As part of substudy A5065s, patients who experience signs or symptoms of paradoxical reactions (i.e., new persistent fevers that develop after initiating HAART and which last for more than 1 week without an identifiable source; marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates; worsening or emergence of cervical adenopathy on serial physical examinations; or worsening of other tuberculous lesions) have additional clinical evaluations (including a chest x-ray, a target clinical assessment, concomitant medications, and signs and symptoms) weekly for 4 weeks, then every month thereafter until the symptoms resolve.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- Nelfinavir mesylate, Ethambutol hydrochloride, Isoniazid, Pyrazinamide, Lamivudine
- Keywords
- Tuberculosis, Rifabutin, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Antitubercular Agents, Anti-HIV Agents
- Medical subject headings
- HIV Infections, Tuberculosis, AIDS-Related Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfinavir mesylateDrug
Ethambutol hydrochlorideDrug
IsoniazidDrug
PyrazinamideDrug
LamivudineDrug
RifabutinDrug
StavudineDrug
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)
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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 44 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Diane Havlir, Study chairConstance Benson, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004736
- Sponsor's protocol ID
- ACTG A5062
- Other IDs
- AACTG A5062
- Status last verified
- Jun 2003
- First submitted
- 25 Feb 2000
- Last updated
- 11 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral and Immune Dynamics in HIV-Infected Patients With Tuberculosis
- ClinicalTrials.gov ID
- NCT00004736
- Acronym / sponsor ID
- ACTG A5062
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- Tuberculosis, Rifabutin, AIDS-Related Opportunistic Infections, Drug Therapy, Combination, Antitubercular Agents, Anti-HIV Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- 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 if a type of anti-HIV therapy called HAART is effective in lowering levels of HIV and boosting the immune system in HIV-infected patients with tuberculosis (TB).
HIV-infected patients with TB have higher levels of HIV and lower CD4 cell counts (cells in the body that fight infection) than HIV-infected patients without TB. HAART has been effective in reducing HIV levels and increasing CD4 cells in patients without TB. However, its effects in HIV-infected patients with TB are unknown.
Detailed description
Previous studies have focused on characterizing viral and immune dynamics after initiation of HAART in patients without opportunistic infection. The development of TB in HIV-infected individuals is associated with an elevation in HIV RNA levels, a decrease in CD4 cell counts, and an increase in activated (CD38) lymphocytes and proinflammatory cytokines (IL-1, TNF-alpha, and IL-6). Response to HAART may differ in individuals with an active opportunistic infection such as TB.
HIV-infected patients with active TB follow an anti-TB regimen including rifabutin and are observed for a maximum of 24 weeks before they initiate HAART. Plasma samples for 24-hour post-rifabutin dosing are collected at entry and at Weeks 4, 8, and 12, then again at Weeks 2, 3, 4, 12, and 24 after HAART initiation. Analyses of these samples are used to explore the relationship between cytokines and rifabutin metabolism and the effect of nelfinavir on rifabutin pharmacokinetics. The HAART regimen is nelfinavir plus lamivudine (3TC) plus either zidovudine (ZDV) or stavudine (d4T). After initiation of HAART, all patients undergo intensive monitoring of viral and immune dynamics for 2 months. The patients continue to be followed for 1 year from the time of starting HAART. Neither the HAART drug regimen nor anti-TB medications will be provided by the study and must be obtained by prescription. If patients are intolerant of the HAART regimen or exhibit virologic rebound, primary providers can alter or modify this regimen. As part of substudy A5065s, patients who experience signs or symptoms of paradoxical reactions (i.e., new persistent fevers that develop after initiating HAART and which last for more than 1 week without an identifiable source; marked worsening or emergence of intrathoracic lymphadenopathy, pulmonary infiltrates; worsening or emergence of cervical adenopathy on serial physical examinations; or worsening of other tuberculous lesions) have additional clinical evaluations (including a chest x-ray, a target clinical assessment, concomitant medications, and signs and symptoms) weekly for 4 weeks, then every month thereafter until the symptoms resolve.
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 (9 listed)
- Are HIV-positive.
- Have an HIV RNA level of 20,000 copies/ml or more within 30 days of study entry.
- Are at least 18 years old.
- Agree to use an effective method of birth control during the study.
- Agree to be treated with rifabutin at least 2 weeks before starting HAART (applies only to patients infected with TB).
Key exclusion criteria (7 listed)
- Have taken a combination of anti-HIV drugs for greater than 3 months.
- Have started HAART since they were infected with TB (applies only to patients infected with TB).
- Are resistant to more than one medication used to treat TB (applies only to patients infected with TB).
- Have had more than 16 weeks of TB therapy (applies only to patients infected with TB).
- Are taking rifampin to treat TB and cannot switch to rifabutin at least 2 weeks before starting HAART (applies only to patients infected with TB).
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 |
|---|---|---|
| Nelfinavir mesylate | Drug | – |
| Ethambutol hydrochloride | Drug | – |
| Isoniazid | Drug | – |
| Pyrazinamide | Drug | – |
| Lamivudine | Drug | – |
| Rifabutin | Drug | – |
| Stavudine | Drug | – |
| 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 11 Sep 2008.
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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.
Diane Havlir study chair
Constance Benson 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 Nelfinavir mesylate, Ethambutol hydrochloride and Isoniazid in people with HIV Infections and Tuberculosis, 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 9 inclusion and 7 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 11 Sep 2008. 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?
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 11 Sep 2008.