HIV InfectionsPhase 2NCT00002324
The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
A Phase 2 study testing Nevirapine and Zidovudine in people with HIV Infections, run by Boehringer Ingelheim at 18 sites in United States.
Trial summary
PRIMARY: To compare the effect of nevirapine versus placebo alone or in combination with zidovudine (AZT) on CD4 T-cell count and percentage after 3 and 6 months of treatment. To evaluate the safety and tolerance of nevirapine alone or in combination with AZT. 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
- 250 participants
- Where
- 18 sitesUnited States
- Study dates
- Start not givento not given
- 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 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-1 infection, with positive serum antibody to HIV-1 as determined by ELISA or Western blot.
- CD4 count 200-500 cells/mm3 within 4-28 days prior to study entry.
- No conditions indicative of AIDS.
- None of the constitutional symptoms that are specifically excluded.
- Prior AZT for 3-24 months (amended 04/04/94) immediately prior to study entry (Part I) OR no prior AZT (Part II).
- Consent of parent or guardian if less than 18 years of age.
- NOTE:
- Co-enrollment in a protocol involving another investigational drug or biologic is not permitted.
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 compliance with protocol requirements.
- Concurrent Medication:
- Excluded:
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- Investigational drugs other than study 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 (Timentin).
- Biologic response modifiers (alpha interferon, IL-2, immune modulators).
- Patients with the following condition are excluded:
- History of other clinically important disease (i.e., one that precludes participation in the 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 (Timentin).
- Biologic response modifiers (alpha interferon, IL-2, immune modulators).
- Required (for patients in Part I):
- Prior AZT at 500-600 mg daily for at least 3 months but not more than 24 months immediately prior to study entry.
- Chronic use of alcohol or drugs sufficient to impair compliance with protocol requirements.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204
Community Research Initiative of South Florida
Coral Gables, Florida, 33146
Nelson-Tebedo Community Clinic
Dallas, Texas, 75219
Houston Clinical Research Network
Houston, Texas, 77006
Kansas City AIDS Research Consortium
Kansas City, Missouri, 641082792
Chandler Med Ctr
Lexington, Kentucky, 405360084
Goodgame Med Group
Maitland, Florida, 32751
Community Research Initiative on AIDS
New York, New York, 10001
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
Richmond AIDS Consortium
Richmond, Virginia, 23219
Univ of Utah School of Medicine
Salt Lake City, Utah, 84132
UCSD Treatment Ctr
San Diego, California, 92103
Saint Francis Mem Hosp
San Francisco, California, 94109
Med College of Ohio
Toledo, Ohio, 43699
Associates Med and Mental Health
Tulsa, Oklahoma, 74114
Univ of Kansas School of Medicine
Wichita, Kansas, 67214
Wilmington Hosp
Wilmington, Delaware, 19801
About this study
Official title: A Multi-Center, Placebo-Controlled, Double-Blind, Randomized Trial Comparing the Activity, Safety, and Tolerance of 1) 400 Mg Nevirapine in Combination With 500-600 Mg Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 3-24 Months of Prior Zidovudine Therapy and 200-500 CD4 Cells/mm3 and 2) 400 Mg Nevirapine Versus Nevirapine Placebo in Asymptomatic HIV-1 Nucleoside Naive Patients With 200-500 CD4 Cells/mm3
PRIMARY: To compare the effect of nevirapine versus placebo alone or in combination with zidovudine (AZT) on CD4 T-cell count and percentage after 3 and 6 months of treatment. To evaluate the safety and tolerance of nevirapine alone or in combination with AZT.
SECONDARY: To compare the effects of the various treatment combinations on virologic and immunologic markers.
Read the detailed description
In Part I, patients who have had prior AZT therapy receive either nevirapine or placebo in combination with AZT. In Part II, patients who are nucleoside naive receive either nevirapine or matching placebo. After 6 months, patients receive open-label nevirapine.
- Conditions
- HIV Infections
- Being tested
- Nevirapine, Zidovudine
- Keywords
- Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, 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
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.
- 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 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 2
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002324
- Sponsor's protocol ID
- 200C
- Other IDs
- 1038
- Status last verified
- Aug 2002
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Pollard R . Surrogate marker response to NVP/ZDV or ZDV in a blinded clinical trial: correlation to changes in HIV isolate phenotypic susceptibility to NVP and ZDV. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:113
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 Activity, Safety, and Tolerance of 1) 400 Mg Nevirapine in Combination With 500-600 Mg Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 3-24 Months of Prior Zidovudine Therapy and 200-500 CD4 Cells/mm3 and 2) 400 Mg Nevirapine Versus Nevirapine Placebo in Asymptomatic HIV-1 Nucleoside Naive Patients With 200-500 CD4 Cells/mm3
- ClinicalTrials.gov ID
- NCT00002324
- Acronym / sponsor ID
- 200C
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Nevirapine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 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 effect of nevirapine versus placebo alone or in combination with zidovudine (AZT) on CD4 T-cell count and percentage after 3 and 6 months of treatment. To evaluate the safety and tolerance of nevirapine alone or in combination with AZT.
SECONDARY: To compare the effects of the various treatment combinations on virologic and immunologic markers.
Detailed description
In Part I, patients who have had prior AZT therapy receive either nevirapine or placebo in combination with AZT. In Part II, patients who are nucleoside naive receive either nevirapine or matching placebo. After 6 months, patients receive open-label nevirapine.
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-1 infection, with positive serum antibody to HIV-1 as determined by ELISA or Western blot.
Key exclusion criteria (41 listed)
- Malignancy other than limited cutaneous basal cell carcinoma.
- Psychiatric condition sufficient to impair compliance with protocol requirements.
- Investigational drugs other than study drugs.
- Systemic glucocorticoids and steroid hormones.
- Dicumarol, warfarin, and other anticoagulant 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 |
|---|---|---|
| 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.
- BackgroundPollard R . Surrogate marker response to NVP/ZDV or ZDV in a blinded clinical trial: correlation to changes in HIV isolate phenotypic susceptibility to NVP and ZDV. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:113
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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.
18 sites 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 and Zidovudine in people with HIV Infections, run by Boehringer Ingelheim at 18 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 18 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 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 NCT00002324, 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 24 Jun 2005.