HIV InfectionsNCT00002323
A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cell
A study testing Nevirapine and Zidovudine in people with HIV Infections, run by Boehringer Ingelheim at 5 sites in United States.
Trial summary
PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Nevirapine and Zidovudine
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- PCP prophylaxis (trimethoprim-sulfamethoxazole, dapsone, or aerosolized pentamidine), at the discretion of the investigator.
- Antifungal prophylaxis with oral fluconazole or ketoconazole.
- Antiviral prophylaxis for herpes simplex virus with <= 1000 mg/day oral acyclovir.
- Dilantin for prevention and treatment of seizures.
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- Patients must have:
- Asymptomatic HIV infection.
- CD4 count 200-500 cells/mm3.
- No prior AIDS.
- No history of or active HIV-related thrush, vaginal candidiasis, zoster (shingles), excessive weight loss, persistent fever, or diarrhea.
- Tolerated 500-600 mg AZT daily for at least 4 months but no more than 12 months immediately prior to study entry.
- Consent of parent or guardian if less than 18 years of age.
- NOTE:
- Patients may not co-enroll in another protocol involving other investigational drugs or biologics.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malignancy other than limited cutaneous basal cell carcinoma.
- Psychiatric condition sufficient to impair study compliance.
- Concurrent Medication:
- Excluded:
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- Systemic glucocorticoids and steroid hormones.
- Dicumarol, warfarin, and other anticoagulant medications.
- Cimetidine.
- Tolbutamide.
- Doxycycline.
- Chloramphenicol.
- Phenobarbital and other barbiturates.
- Foscarnet.
- Erythromycin.
- Amoxicillin-clavulanate (Augmentin).
- Ticarcillin clavulanate.
- Biologic response modifiers (alpha interferon, IL-2, immune modulators).
- Any investigational drugs other than study drugs.
- Patients with the following prior condition are excluded:
- History of clinically important disease other than HIV infection, that may put patient at risk because of participation in this study.
- Prior Medication:
- Excluded:
- Antiretroviral medications other than AZT.
- Excluded within 4 weeks prior to study entry:
- Immunosuppressive or cytotoxic drugs or other experimental drugs.
- Systemic glucocorticoids and steroid hormones.
- Dicumarol, warfarin, and other anticoagulant medications.
- Cimetidine.
- Tolbutamide.
- Doxycycline.
- Chloramphenicol.
- Phenobarbital and other barbiturates.
- Foscarnet.
- Erythromycin.
- Amoxicillin-clavulanate (augmentin).
- Ticarcillin clavulanate.
- Biologic response modifiers (alpha interferon, IL-2, immune modulators).
- Required:
- AZT at 500-600 mg/day for at least 4 months but no more than 12 months immediately preceding study entry.
- Chronic use of alcohol or drugs sufficient to impair study compliance.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Hosp
Baltimore, Maryland, 21287
Northwestern Univ Med School
Chicago, Illinois, 60611
Univ TX Galveston Med Branch
Galveston, Texas, 775550882
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018
Washington Univ School of Medicine
St Louis, Missouri, 63108
About this study
Official title: A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cells/mm3
PRIMARY: To compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage.
SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two regimens.
Read the detailed description
Patients receive combination nevirapine/AZT or AZT alone. Patients are evaluated for virologic and immunologic activity at 3 and 6 months.
- Conditions
- HIV Infections
- Being tested
- Nevirapine, Zidovudine
- Keywords
- Drug Therapy, Combination, Zidovudine, Nevirapine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NevirapineDrug
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 Boehringer IngelheimThe 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
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002323
- Sponsor's protocol ID
- 200B
- Other IDs
- BIPI 1037
- Status last verified
- Aug 2002
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4+ Cells/mm3
- ClinicalTrials.gov ID
- NCT00002323
- Acronym / sponsor ID
- 200B
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Zidovudine, Nevirapine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- 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 compare the virologic activity (quantitative RNA PCR, quantitative PBMC) of the combination of nevirapine and zidovudine (AZT) versus AZT alone after 3 and 6 months of treatment. To compare the effects of these two regimens on CD4 T-cell count and percentage.
SECONDARY: To compare and evaluate other markers of immunologic and virologic activity in patients receiving nevirapine/AZT versus AZT alone. To compare the effects of the two regimens on clinical signs and symptoms. To evaluate the safety and tolerance of the two regimens.
Detailed description
Patients receive combination nevirapine/AZT or AZT alone. Patients are evaluated for virologic and immunologic activity at 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- PCP prophylaxis (trimethoprim-sulfamethoxazole, dapsone, or aerosolized pentamidine), at the discretion of the investigator.
- Antifungal prophylaxis with oral fluconazole or ketoconazole.
- Antiviral prophylaxis for herpes simplex virus with <= 1000 mg/day oral acyclovir.
- Dilantin for prevention and treatment of seizures.
- Asymptomatic HIV infection.
Key exclusion criteria (41 listed)
- Malignancy other than limited cutaneous basal cell carcinoma.
- Psychiatric condition sufficient to impair study compliance.
- Systemic glucocorticoids and steroid hormones.
- Dicumarol, warfarin, and other anticoagulant medications.
- Cimetidine.
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 | – |
| 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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nevirapine and Zidovudine in people with HIV Infections, run by Boehringer Ingelheim at 5 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 15 inclusion and 41 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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 24 Jun 2005.