HIV InfectionsPhase 2NCT00000747
An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3
A Phase 2 study testing Nevirapine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts greater than or equal to 500 cells/mm3. Secondary: To evaluate the effect of nevirapine on surrogate markers. 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?
- Nevirapine
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 1994
- Phase
- Phase 2
- 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:
- Positive serum antibody to HIV-1 by ELISA or Western blot.
- CD4 count >= 500 cells/mm3 within 2 months prior to study entry, with two additional counts averaging >= 450 cells/mm3 at baseline and on study day 0 (taken at least 48 hours apart).
- No AIDS-defining disease.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms and conditions are excluded:
- More than four loose stools per day.
- Participation in other experimental trials including vaccine trials.
- Concurrent Medication:
- Excluded:
Show all 24Show fewer
- Other approved or investigational antiretroviral agents, other investigational agents, or vaccines.
- Glucocorticoids and steroid hormones.
- Dicumarol, warfarin, and other anticoagulants.
- Digitoxin.
- Valproic acid.
- Tolbutamide.
- Doxycycline.
- Chloramphenicol.
- Phenobarbital and other barbiturates.
- Excluded 4 hours before or after a nevirapine dose:
- Antacids (particularly those containing calcium carbonate).
- H-2 blockers, carafate, cholestyramine resin, alcohol and alcohol-containing substances, and benzodiazepines (e.g., diazepam, triazolam).
- Patients with the following prior conditions are excluded:
- History of clinically important disease other than HIV infection.
- Prior Medication:
- Excluded within 1 month prior to study entry:
- Any immunosuppressive, immunomodulatory, or cytotoxic treatment.
- Use of drugs or alcohol sufficient to impair compliance with protocol requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts greater than or equal to 500 cells/mm3.
Secondary: To evaluate the effect of nevirapine on surrogate markers. The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts <= 400 cells/mm3. In persons with less advanced HIV disease and less viral burden, the emergence of resistance may be delayed, thus permitting evaluation for beneficial effect in a population where there is currently no established therapy.
Read the detailed description
The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts <= 400 cells/mm3. In persons with less advanced HIV disease and less viral burden, the emergence of resistance may be delayed, thus permitting evaluation for beneficial effect in a population where there is currently no established therapy.
Ten patients receive nevirapine daily for 12 weeks. After 12 weeks of therapy, patients in whom resistance was not evident at week 4 and who have an adequate safety profile continue receiving nevirapine for an additional 12 weeks. Clinical and immunological assessments are performed at weeks 4, 8, 12, 16, 20, and 24. Virological assessments are performed at week 24 only. If 50 percent of patients develop resistance at any time, the study is discontinued.
- Conditions
- HIV Infections
- Being tested
- Nevirapine
- Keywords
- Drug Resistance, AIDS-Related Complex, Antiviral Agents, Nevirapine
- Medical subject headings
- HIV Infections, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
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 completionDec 1994
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Boehringer Ingelheim
- Investigators
- Richman D, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000747
- Sponsor's protocol ID
- ACTG 208
- Other IDs
- BI 00947
- Status last verified
- Feb 2011
- First submitted
- 2 Nov 1999
- Last updated
- 1 Mar 2011
- Results posted
- No
Publications
Havlir D. An open-label pilot study to evaluate the development of resistance to nevirapine (BI-RG-587) in HIV-infected patients with CD4 cell count > or = 500/mm. ACTG 208 Study Team. Int Conf AIDS. 1993 Jun 6-11;9(1):470 (abstract no PO-B26-2009)
Havlir D, McLaughlin MM, Richman DD. A pilot study to evaluate the development of resistance to nevirapine in asymptomatic human immunodeficiency virus-infected patients with CD4 cell counts of > 500/mm3: AIDS Clinical Trials Group Protocol 208. J Infect Dis. 1995 Nov;172(5):1379-83. doi: 10.1093/infdis/172.5.1379.
PubMed 7594683
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Pilot Study to Evaluate the Development of Resistance to Nevirapine (BI-RG-587) in HIV-Infected Patients With CD4 Cell Count >= 500/mm3
- ClinicalTrials.gov ID
- NCT00000747
- Acronym / sponsor ID
- ACTG 208
- Conditions
- HIV Infections
- Keywords
- Drug Resistance, AIDS-Related Complex, Antiviral Agents, Nevirapine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Boehringer Ingelheim
- Primary completion
- Dec 1994 (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.
Primary: To evaluate the rate of development of resistance to nevirapine in HIV-1 infected individuals. To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts greater than or equal to 500 cells/mm3.
Secondary: To evaluate the effect of nevirapine on surrogate markers. The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts <= 400 cells/mm3. In persons with less advanced HIV disease and less viral burden, the emergence of resistance may be delayed, thus permitting evaluation for beneficial effect in a population where there is currently no established therapy.
Detailed description
The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts <= 400 cells/mm3. In persons with less advanced HIV disease and less viral burden, the emergence of resistance may be delayed, thus permitting evaluation for beneficial effect in a population where there is currently no established therapy.
Ten patients receive nevirapine daily for 12 weeks. After 12 weeks of therapy, patients in whom resistance was not evident at week 4 and who have an adequate safety profile continue receiving nevirapine for an additional 12 weeks. Clinical and immunological assessments are performed at weeks 4, 8, 12, 16, 20, and 24. Virological assessments are performed at week 24 only. If 50 percent of patients develop resistance at any time, the study is discontinued.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Positive serum antibody to HIV-1 by ELISA or Western blot.
- CD4 count >= 500 cells/mm3 within 2 months prior to study entry, with two additional counts averaging >= 450 cells/mm3 at baseline and on study day 0 (taken at least 48 hours apart).
- No AIDS-defining disease.
Key exclusion criteria (24 listed)
- More than four loose stools per day.
- Participation in other experimental trials including vaccine trials.
- Other approved or investigational antiretroviral agents, other investigational agents, or vaccines.
- Glucocorticoids and steroid hormones.
- Dicumarol, warfarin, and other anticoagulants.
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 |
|---|---|---|
| Nevirapine | 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 1 Mar 2011.
- BackgroundHavlir D. An open-label pilot study to evaluate the development of resistance to nevirapine (BI-RG-587) in HIV-infected patients with CD4 cell count > or = 500/mm. ACTG 208 Study Team. Int Conf AIDS. 1993 Jun 6-11;9(1):470 (abstract no PO-B26-2009)
- Background: PubMed 7594683Havlir D, McLaughlin MM, Richman DD. A pilot study to evaluate the development of resistance to nevirapine in asymptomatic human immunodeficiency virus-infected patients with CD4 cell counts of > 500/mm3: AIDS Clinical Trials Group Protocol 208. J Infect Dis. 1995 Nov;172(5):1379-83. doi: 10.1093/infdis/172.5.1379.
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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.
Richman D study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nevirapine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 4 inclusion and 24 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 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 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NCT00000747, which also lists 2 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 Mar 2011.