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HIV InfectionsPhase 4NCT02184299

Study of Nevirapine and Prednisone to Determine the Safety and Effectiveness in Preventing Nevirapine Associated Rash in Human Immunodeficiency Virus (HIV) Infected Patients

A Phase 4 study testing Nevirapine and Prednisone in people with HIV Infections, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study to determine the incidence of rash between the group receiving nevirapine without prednisone and the group receiving nevirapine with prednisone Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
HIV Infections
What is being tested?
Nevirapine and Prednisone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
No sites listed yet
Study dates
Apr 1999to Jan 2000
Phase
Phase 4
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients of any ethnic group between the ages of 18 and 65 years of age
  • Women of childbearing potential had to utilize adequate birth control to prevent pregnancy for study duration. Due to possibility that study drugs could alter the effectiveness of oral contraceptives or depo-progesterone, oral contraceptives or depo-progesterone were not to be used as the sole form of birth control for the duration of this study
  • Women of childbearing potential had to have a negative serum human chorionic gonadotropin (b-hCG) within 14 days prior to initiation of study therapy
  • Presence of HIV-1 infection as documented by any licensed Enzyme-Linked Immunosorbent Assay (ELISA) test kit and confirmed by either Western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to study entry
  • A CD4+ cell count of 100 cells/mm³ documented within 30 days of baseline visit. If a patient had a history of a clinical AIDS defining event, i.e. Pneumocystis carinii pneumonia (PCP), Kaposi sarcoma, etc, his/her CD4+ cell count had to be >= 200 cells/mm³
  • Patients could have either a) no prior antiretroviral therapy or b) prior antiretroviral therapy but no Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI) therapy. Antiretroviral experienced patients eligible to enroll in this study were patients who had any of the following characteristics
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  • Switching Patients: Patients with two consecutive ultra-sensitive HIV-RNA assay results below the limit of quantification (BLQ) at least one week apart
  • Patients Optimizing Therapy: Patients who had responded with substantial drops in HIV-RNA counts without reaching BLQ or patients who had failed their current regimen and needed to change to a new drug regimen
  • Patients Re-starting Therapy: Patients who were antiretroviral experienced but had not received antiretroviral therapy in the previous three months before enrolling in this study All antiretroviral experienced patients had to have been on a stable regimen or for at least three months immediately prior to their enrollment or they had to have been on no antiretroviral therapy for at least three months immediately prior to their enrollment
  • Ability and willingness to give written informed consent and comply with study requirements
  • Patients must have had an ambulatory performance score of >= 80 on the Karnofsky scale

Who cannot join

  • Female patients who were pregnant or breast-feeding
  • Patients with an acute and/or active AIDS defining illness
  • History of any illness or drug allergy that in the opinion of the Investigator could confound the results of the study or pose additional risk in administering nevirapine to the patient
  • Patients with active invasive infections including pneumonia, septicemia, meningitis and encephalitis; not including upper respiratory infections, dermatologic infection, oral infection and urinary tract infection
  • Patients who where currently taking any prescription or non-prescription drug that in the opinion of the investigator in consultation with Boehringer Ingelheim Pharmaceuticals Incorporated (BIPI) medical monitor could interfere with either the absorption, distribution or metabolism of nevirapine or prednisone
  • The following laboratory parameters documented within 30 days prior to baseline visit:
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  • Hemoglobin < 9.1 g/dL for men; < 8.9 g/dL for women
  • Absolute neutrophil counts < 750 cells/mm³
  • Platelet counts < 50000 platelets/mm³
  • AST (SGOT)/ALT (SGPT) > five times upper limit of normal range (ULN)
  • Creatinine > two times ULN
  • Documented or suspected acute hepatitis within 30 days prior to baseline visit irrespective of Aspartate Aminotransferase (AST) Serum Glutamic-Oxaloacetic Transaminase (SGOT) and Alanine Aminotransferase (ALT) Serum Glutamic-Pyruvic Transaminase (SGPT) values that were five times ULN
  • Unexplained temperature > 38.5 °C for any seven days or chronic diarrhea defined as more than three stools per day that persisted for 15 days within 30 days prior to baseline visit
  • History of illnesses that contraindicated the use of prednisone such as hypertension, diabetes and diseases of the adreno-pituitary axis. Any chronic gastrointestinal conditions that could interfere with study drug absorption
  • Receipt of the following
  • Any NNRTI therapy at anytime prior to baseline visit
  • Interferons, interleukins or any vaccine including HIV vaccine within 30 days prior to baseline visit
  • Any investigational agents that needed to be continued during the study
  • Abacavir
  • Patients who would be taking known inhibitors or inducers of P450 metabolic enzymes including ketoconazole, itraconazole, rifampin and phenytoin were not enrolled. In addition the following drugs were not allowed during the study: cytochrome P450 3A4 substrates such a terfenadine, astemizole, cisapride, triazolam and midazolam. Non-nucleoside reverse transcriptase inhibitors other than study-provided nevirapine were not allowed
  • The presence of skin rash or mucosal lesions that in the opinion of the Investigator could compromise the wellbeing of the patient or confound that assessment of a nevirapine-associated rash. Localized skin rashes (e.g. facial folliculitis or contact dermatitis) were not to be the only basis for exclusion from this trial
  • Presence of occult (microscopic) or frank (macroscopic) blood in the stools
  • Any medical condition which in the opinion of the Investigators would interfere with the patient's ability to participate in or adhere to the requirements of this protocol

About this study

Official title: A Multicenter, Randomized, Open-label, Controlled Study of Nevirapine (VIRAMUNE®) and a Short Course of Prednisone to Determine the Safety and Effectiveness of This Strategy in Preventing Nevirapine (VIRAMUNE®) Associated Rash.

Study to determine the incidence of rash between the group receiving nevirapine without prednisone and the group receiving nevirapine with prednisone

Conditions
HIV Infections
Being tested
Nevirapine, Prednisone
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02184299
Study groupRoleWhat they receive
Nevirapine + PrednisoneExperimentalweek 1-2: Nevirapine + Prednisone week 3-24: Nevirapine alone
Receives: Drug: Nevirapine; Drug: Prednisone
NevirapineActive comparatorweek 1-24: Nevirapine
Receives: Drug: Nevirapine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of rash

    Measured: up to 42 days after initiation of nevirapine

Secondary outcomes (4)

  1. Severity of rash

    Measured: up to 42 days after initiation of nevirapine

  2. Change in Human Immunodeficiency Virus -1 Ribonucleic Acid (HIV-1 RNA) count

    Measured: up to 24 weeks

  3. Number of patients with adverse events

    Measured: up to 198 days

  4. Change in Lymphocytes expressing CD4+ Surface Marker (CD4+) count

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2014 (estimated)
  2. Study startApr 1999
  3. Primary completionJan 2000

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02184299
Sponsor's protocol ID
1100.1286
Status last verified
Jul 2014
First submitted
8 Jul 2014
Last updated
14 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nevirapine and Prednisone in people with HIV Infections, run by Boehringer Ingelheim.

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 11 inclusion and 23 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 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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.

What does the primary outcome measure?

Incidence of rash (time frame: up to 42 days after initiation of nevirapine). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02184299.

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 14 Jul 2014.

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