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HIV InfectionsPhase 2NCT00000770

A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine

A Phase 2 study testing Nevirapine, Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 44 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

To assess the safety and toxicity of zidovudine (AZT)/didanosine (ddI) versus AZT/ddI combined with nevirapine in HIV-infected patients, and to obtain preliminary anti-HIV activity data using immunologic and virologic markers. 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, Zidovudine and Didanosine
How many people
400 participants
Where
44 sitesUnited States
Study dates
Start not givento Nov 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 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Required:
  • PCP prophylaxis for patients with CD4 count < 200 cells/mm3 or a prior history of PCP.
  • Allowed:
  • Trimethoprim with sulfamethoxazole or dapsone, intravenous pentamidine, atovaquone, primaquine-clindamycin or trimetrexate for acute PCP.
  • Topical antifungals, clotrimazole, ketoconazole, fluconazole, and amphotericin B for treatment of mucosal and esophageal candidiasis.
Show all 24Show fewer
  • Prophylaxis or therapy for opportunistic infections, as indicated, with other medications such as itraconazole, isoniazid, pyrazinamide, clofazimine, clarithromycin, azithromycin, ethambutol, amikacin, ciprofloxacin, ofloxacin, pyrimethamine, sulfadiazine, and clindamycin.
  • Maintenance therapy for opportunistic infections as long as patients have been on a stable dosage regimen for 1 month prior to study entry.
  • Ganciclovir for CMV retinitis or gastrointestinal disease as long as patients have been on a stable dose for at least 1 month prior to study entry with no grade 3 or 4 neutropenia or dependence on G-CSF.
  • Acyclovir (<= 1000 mg/day) for maintenance of herpes simplex virus infections.
  • Erythropoietin or G-CSF if clinically indicated.
  • Antibiotics for bacterial infections unless specifically excluded.
  • Rifampin or rifabutin.
  • Symptomatic treatments such as antipyretics, analgesics, and antiemetics.
  • Concurrent Treatment:
  • Allowed:
  • Local radiation therapy.
  • Prior Medication: Required:
  • At least 6 months of prior cumulative nucleoside therapy with AZT, ddI, or ddC, given as monotherapy or in combination.
  • Patients must have:
  • Prior or current documentation of HIV seropositivity by ELISA confirmed by Western blot, positive HIV antigen, or positive HIV culture, or a second antibody test by a method other than ELISA.
  • CD4 count <= 350 cells/mm3.
  • Prior cumulative nucleoside therapy of >= 6 months.
  • Consent of parent or guardian if less than 18 years of age.

Who cannot join

  • Concurrent Medication:
  • Excluded:
  • Antiretroviral therapies other than study medications.
  • Systemic corticosteroids given consecutively for > 21 days.
  • Induction or maintenance with foscarnet.
  • Systemic cytotoxic chemotherapy for a malignancy.
Show all 24Show fewer
  • Erythromycin.
  • Coumadin/warfarin.
  • Phenytoin or phenobarbital.
  • Amoxicillin/clavulanate acid (Augmentin) or ticarcillin/clavulanate acid (Timentin).
  • Patients with the following prior conditions are excluded:
  • History of pancreatitis.
  • History of intolerance to 500 or 600 mg/day AZT or to 400 mg/day ddI tablets or 500 mg/day ddI sachets.
  • History of grade 2 or worse peripheral neuropathy.
  • Prior Medication:
  • Excluded at any time:
  • Prior non-nucleoside reverse transcriptase inhibitors (NVP; L697,611; TIBO; atevirdine).
  • Excluded within 14 days prior to study entry:
  • Acute treatment for a serious infection or any opportunistic infection.
  • Biologic response modifiers such as interferon and IL-2.
  • Erythromycin.
  • Coumadin/warfarin.
  • Phenytoin or phenobarbital.
  • Ticarcillin/clavulanate acid (Timentin) or amoxicillin/clavulanate acid (Augmentin).

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Univ of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Harvard (Massachusetts Gen Hosp)

    Boston, Massachusetts, 02114

  • Boston Med Ctr

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess - West Campus

    Boston, Massachusetts, 02215

  • Beth Israel Deaconess Med Ctr

    Boston, Massachusetts, 02215

  • Univ of North Carolina

    Chapel Hill, North Carolina, 275997215

  • Carolinas Med Ctr

    Charlotte, North Carolina, 28203

  • Northwestern Univ Med School

    Chicago, Illinois, 60611

  • Cook County Hosp

    Chicago, Illinois, 60612

  • Rush Presbyterian - Saint Luke's Med Ctr

    Chicago, Illinois, 60612

  • Univ of Cincinnati

    Cincinnati, Ohio, 452670405

  • Univ of Colorado Health Sciences Ctr

    Denver, Colorado, 80262

  • City Hosp Ctr at Elmhurst / Mount Sinai Hosp

    Elmhurst, New York, 11373

  • Moses H Cone Memorial Hosp

    Greensboro, North Carolina, 27401

  • Indiana Univ Hosp

    Indianapolis, Indiana, 462025250

  • Univ of Iowa Hosp and Clinic

    Iowa City, Iowa, 52242

  • Univ of Southern California / LA County USC Med Ctr

    Los Angeles, California, 900331079

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

  • Hennepin County Med Clinic

    Minneapolis, Minnesota, 55415

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455

  • Beth Israel Med Ctr

    New York, New York, 10003

  • Saint Clare's Hosp and Health Ctr

    New York, New York, 10019

  • Cornell Univ Med Ctr

    New York, New York, 10021

  • Mem Sloan - Kettering Cancer Ctr

    New York, New York, 10021

  • Mount Sinai Med Ctr

    New York, New York, 10029

  • Highland Gen Hosp / San Francisco Gen Hosp

    Oakland, California, 946021018

  • Summitt Med Ctr / San Francisco Gen Hosp

    Oakland, California, 94609

  • Univ of Nebraska Med Ctr

    Omaha, Nebraska, 681985130

  • Girard Med Ctr

    Philadelphia, Pennsylvania, 191046073

  • Univ of Pennsylvania at Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson Univ Hosp

    Philadelphia, Pennsylvania, 191075098

  • Wake County Dept of Health

    Raleigh, North Carolina, 27610

  • St Paul Ramsey Med Ctr

    Saint Paul, Minnesota, 55101

  • Univ of California / San Diego Treatment Ctr

    San Diego, California, 921036325

  • San Francisco AIDS Clinic / San Francisco Gen Hosp

    San Francisco, California, 941102859

  • San Francisco Gen Hosp

    San Francisco, California, 941102859

  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr

    The Bronx, New York, 10461

  • Comprehensive Health Care Ctr / Bronx Municipal Hosp

    The Bronx, New York, 10461

  • Montefiore Drug Treatment Ctr / Bronx Municipal Hosp

    The Bronx, New York, 10461

  • Montefiore Family Health Ctr / Bronx Municipal Hosp

    The Bronx, New York, 10461

  • Samaritan Village Inc / Bronx Municipal Hosp

    The Bronx, New York, 10461

  • Jack Weiler Hosp / Bronx Municipal Hosp

    The Bronx, New York, 10465

  • Montefiore Med Ctr / Bronx Municipal Hosp

    The Bronx, New York, 10467

  • North Central Bronx Hosp / Bronx Municipal Hosp

    The Bronx, New York, 10467

Other trials in United States

About this study

To assess the safety and toxicity of zidovudine (AZT)/didanosine (ddI) versus AZT/ddI combined with nevirapine in HIV-infected patients, and to obtain preliminary anti-HIV activity data using immunologic and virologic markers.

Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected patients may prove more effective.

Read the detailed description

Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected patients may prove more effective.

Patients are randomized to receive AZT/ddI plus either nevirapine or placebo daily for 48 weeks, with possible extension for at least 12 weeks. At eight participating sites, ACTG 808 and 809 will be conducted as virologic and pharmacokinetic substudies.

Conditions
HIV Infections
Being tested
Nevirapine, Zidovudine, Didanosine
Keywords
Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Nevirapine
Medical subject headings
HIV Infections, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

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

Timeline

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

  1. First posted31 Aug 2001 (estimated)
  2. Study completionNov 1994

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 2
Primary purpose
Treatment
Masking
Double blind
Enrolment
400 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000770
Sponsor's protocol ID
ACTG 241
Other IDs
11218
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • D'Aquila RT, Hughes MD, Johnson VA, Fischl MA, Sommadossi JP, Liou SH, Timpone J, Myers M, Basgoz N, Niu M, Hirsch MS. Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. A randomized, double-blind, placebo-controlled trial. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators. Ann Intern Med. 1996 Jun 15;124(12):1019-30. doi: 10.7326/0003-4819-124-12-199606150-00001.

    PubMed 8633815

  • Dusek A, Hall D, Lamson M, Myers M. Once-daily dosing of nevirapine: a retrospective, cross-study analysis. Int Conf AIDS. 1998;12:85 (abstract no 12360)

  • Leigh Brown AJ, D'Aquila RT, Johnson VA, Kuritzkes DR, Richman DD. Baseline sequence clusters predict response to combination therapy in ACTG 241. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:211 (abstract no 704)

  • Fiscus SA, Welles SL, Spector SA, Lathey JL. Length of incubation time for human immunodeficiency virus cultures. J Clin Microbiol. 1995 Jan;33(1):246-7. doi: 10.1128/jcm.33.1.246-247.1995.

    PubMed 7699053

  • D'Aquila RT, Sutton L, Savara A, Hughes MD, Johnson VA. CCR5/delta(ccr5) heterozygosity: a selective pressure for the syncytium-inducing human immunodeficiency virus type 1 phenotype. NIAID AIDS Clinical Trials Group Protocol 241 Virology Team. J Infect Dis. 1998 Jun;177(6):1549-53. doi: 10.1086/515307.

    PubMed 9607832

  • Virus sidesteps convergent therapy. GMHC Treat Issues. 1995 Jan;9(1):6.

    PubMed 11367380

  • Precious H, Leigh Brown AJ, Gunthard HF, Wong JK, D'Aquila RT, Johnson VA, Kuritzkes DR, Richman DD. A multiple regression model predicting response to combination therapy from baseline sequence data identifies amino acid sites not previously associated with resistance. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:69 (abstract no 14)

  • Zhou XJ, Sheiner LB, D'Aquila RT, Hughes MD, Hirsch MS, Fischl MA, Johnson VA, Myers M, Sommadossi JP. Population pharmacokinetics of nevirapine, zidovudine, and didanosine in human immunodeficiency virus-infected patients. The National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators. Antimicrob Agents Chemother. 1999 Jan;43(1):121-8. doi: 10.1128/AAC.43.1.121.

    PubMed 9869576

  • Hall D, Robinson P, Cort S, Kohlbrenner V, Leitz G, Myers M. Duration of effect of nevirapine (NVP), a cross-trial analysis of three controlled studies. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:79

  • Hughes MD, Johnson VA, Hirsch MS, Bremer JW, Elbeik T, Erice A, Kuritzkes DR, Scott WA, Spector SA, Basgoz N, Fischl MA, D'Aquila RT. Monitoring plasma HIV-1 RNA levels in addition to CD4+ lymphocyte count improves assessment of antiretroviral therapeutic response. ACTG 241 Protocol Virology Substudy Team. Ann Intern Med. 1997 Jun 15;126(12):929-38. doi: 10.7326/0003-4819-126-12-199706150-00001.

    PubMed 9182469

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nevirapine, Zidovudine and Didanosine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 44 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 24 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 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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 NCT00000770, which also lists 10 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 4 Nov 2021.

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