AzTrials
AzTrials

HIV InfectionsNCT00000919

A Study to Evaluate Various Combinations of Anti-HIV Medications to Treat Early HIV Infection

A study testing Indinavir sulfate, Lamivudine/Zidovudine and Ritonavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 80 sites in 4 countries.

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

The purpose of this study is to compare the effectiveness of various combinations of anti-HIV drugs in HIV-positive men and women. Patients receive specific combinations of 3 or 4 of the following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV), lamivudine (3TC), or zidovudine (ZDV). 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?
Indinavir sulfate, Lamivudine/Zidovudine and Ritonavir
How many people
900 participants
Where
80 sitesin 4 countries
Study dates
Start not givento Nov 2002
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:
  • [Required: AS PER AMENDMENT 7/5/00:
  • Chemoprophylaxis for Pneumocystis carinii pneumonia if CD4+ cell count is less than or equal to 200 cells/mm3.]
  • [Suggested as an alternative agent for chemoprophylaxis against Mycobacterium avium complex:
  • Azithromycin.]
  • [Allowed: AS PER AMENDMENT 7/5/00:
Show all 40Show fewer
  • Topical and oral antifungal agents. Oral itraconazole may be administered concurrently with IDV if the dose of IDV is reduced to 600 mg every 8 hours.
  • Treatment, maintenance, or chemoprophylaxis for opportunistic infections, as clinically indicated unless otherwise prohibited by the protocol.
  • All antibiotics, as clinically indicated unless otherwise prohibited by the protocol.
  • Systemic corticosteroid use for 21 days or less for acute problems, as medically indicated.
  • Recombinant erythropoietin (rEPO, epoetin alfa, Epogen, epoetin beta, Marogen), granulocyte colony-stimulating factor (G-CSF, filgrastim, Neupogen), and granulocyte-macrophage colony-stimulating factor (GM-CSF, Regramostim).
  • Regularly prescribed medications, such as antipyretics, analgesics, allergy medications, antidepressants, sleep medications, oral contraceptives, megestrol acetate (Megace), testosterone, or any other medications, as medically indicated unless otherwise prohibited by the protocol. NOTE: Due to the possibility that study medications may alter the effectiveness of oral contraceptives or depoprogesterone, these agents must not be used as the sole form of birth control, because the role of some study medications on the effectiveness of these methods has not yet been established.
  • Alternative therapies, such as vitamins.
  • Medications requiring low gastric pH if not administered at the same time as buffered ddI. Patients taking these agents should do so at least 2 hours before ddI.]
  • Vaccinations, if administered at least 2 weeks prior to an HIV RNA viral load evaluation.
  • [Allowed with caution: AS PER AMENDMENT 7/5/00:
  • Oral ketoconazole with IDV.
  • Medications that interact with PIs as substrates, inhibitors, or inducers, including, but not limited to:
  • allopurinol, alprazolam, amitriptyline, atorvastatin, bupropion, carbamazepine, cerivastatin, chlorpheniramine, chlorpromazine, chlorzoxazone, cimetidine, clarithromycin, clofibrate, clorazepate, clozapine, codeine, dapsone, desipramine, diazepam, diltiazem, disopyramide, encainide, erythromycin, estazolam, estrogens and progesterones, fluoxetine, flurazepam, fluvastatin, glucocorticoids, hypericum perforatum (St. John's wort), imipramine, isoniazid, itraconazole, ketoconazole, labetalol, lamotrigine, lidocaine, lovastatin, mexiletine, morphine, naloxone, nefazodone, nifedipine, nortriptyline, opioids, oxazepam, pentazocine, phenobarbital, phenytoin, promethazine, propofol, propranolol and other beta blockers, sildenafil, simvastatin, temazepam, T3 (thyroid hormone), warfarin, valproic acid, and zolpidem.
  • Drugs with high protein-binding properties, nephrotoxic drugs, and opiate agonists (e.g., methadone or buprenorphine).]
  • NOTE:
  • Refer to package insert for potential drug interactions with IDV, RTV, NFV, or APV that may require therapeutic drug monitoring and/or adjustment of concomitant medications.]
  • [Allowed with extreme caution:
  • AS PER AMENDMENT 7/5/00:
  • ddI, as clinically indicated in patients with known risk factors, including, but not limited to, alcohol abuse, morbid obesity, hypertriglyceridemia, cholelithiasis, endoscopic retrograde cholangiopancreatography, use of medications known to cause pancreatitis (e.g., pentamidine) and use of medications known or thought to increase exposure to ddI (e.g., HU, allopurinol).]
  • Concurrent Treatment:
  • [Allowed:
  • AS PER AMENDMENT 7/5/00:
  • Acupuncture and visualization techniques.]
  • Patients must have:
  • HIV infection, as documented by any licensed ELISA test kit and confirmed by either Western blot, HIV culture, HIV antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA at any time prior to study entry.
  • Plasma HIV-1 RNA of 500 copies/ml or more, confirmed by the Roche Amplicor assay only and performed within 60 days [AS PER AMENDMENT 5/5/99:
  • 70 days] of study entry by any certified laboratory.
  • Inclusion laboratory parameters, documented within 14 days prior to study entry (see lab values).
  • [AS PER AMENDMENT 9/9/99:
  • Co-enrollment on ACTG A5005s (Metabolism Substudy) is required for patients enrolling under Version 3.0 of ACTG 384.]
  • Risk Behavior:
  • [Allowed with caution:
  • AS PER AMENDMENT 7/5/00:
  • Alcoholic beverages.]

Who cannot join

  • Co-existing Condition:
  • Patients with the following condition are excluded:
  • AIDS-related malignancy other than minimal Kaposi's sarcoma.
  • Concurrent Medication:
  • [Excluded:
  • AS PER AMENDMENT 7/5/00:
Show all 41Show fewer
  • Chronic systemic corticosteroids.
  • For Steps 1 and 2, all antiretroviral therapies other than study medications. For step 3, contact the team to discuss potential addition or substitution with off-study antiretroviral medications.
  • Investigational drugs without specific approval from the study chairs.
  • Neurotoxic and pancreatotoxic drugs.
  • Systemic cytotoxic chemotherapy.
  • Amiodarone, astemizole, bepridil, cisapride, cholestyramine, ergot and ergot derivatives, flecainide, ganciclovir, interferon alfa, midazolam (unless used for sedation on ACTG 723), pimozide, propafenone, propoxyphene, quinidine, ribavirin, rifampin, sucralfate, terfenadine, and triazolam.
  • Rifabutin for patients on RTV in Step 3 and for patients on Steps 1 and 2 because of the contradictory effects of EFV and NFV on plasma rifabutin levels. If a patient on Step 1 or 2 requires treatment with rifabutin after coming on the study, the team must be notified.
  • Alpha tocopherol (vitamin E) supplementation since vitamin E is contained in the soft gelatin capsule formulation of APV.
  • ddI concurrently with IV pentamidine.
  • Herbal medications.]
  • Patients with the following prior conditions are excluded:
  • Pancreatitis within 3 years of study entry.
  • Current peripheral neuropathy grade 2 or greater or history of peripheral neuropathy grade 3 or greater.
  • Documented or suspected acute hepatitis within 30 days prior to study entry.
  • Unexplained temperature above 38.5 C for any 7 days or chronic diarrhea (defined as more than 3 liquid stools per day persisting for more than 15 days) within 30 days prior to study entry.
  • Any previous hypersensitivity to study drugs or their components.
  • Prior Medication:
  • Excluded:
  • Receipt within 30 days of erythropoietin, G-CSF, or GM-CSF.
  • Treatment within 14 days of study entry with any of the following:
  • amiodarone, astemizole, cisapride, ergot or ergot derivatives, ketoconazole, midazolam, propoxyphene, quinidine, rifampin, terfenidine, or triazolam.
  • Prior antiretroviral therapy for 7 days or more, including protease inhibitors (PIs), nucleoside reverse transcriptase inhibitors (NRTIs), and nonnucleoside reverse transcriptase inhibitors (NNRTIs). [AS PER AMENDMENT 5/5/99:
  • Systemic ketoconazole or itraconazole, intravenous pentamidine, and rifabutin are prohibited. Midazolam is allowed for sedation in patients participating on ACTG 723.]
  • Any vaccination within 14 days prior to study entry.
  • Any immunomodulator or investigational therapy within 30 days prior to study entry.
  • [AS PER AMENDMENT 5/5/99:
  • 6. Rifabutin is discouraged.]
  • Prior Treatment:
  • Excluded:
  • Acute therapy for an infection or other medical illness within 14 days prior to study entry.
  • [AS PER AMENDMENT 5/5/99:
  • Acute therapy for a serious infection or other serious medical illness that is potentially life-threatening and requires systemic therapy and/or hospitalization within 14 days of study entry. Patients with Pneumocystis carinii pneumonia must have completed acute therapy at least 7 days prior to entry and be clinically stable. Patients with other serious infection or serious medical illness who must continue chronic therapy must have completed at least 14 days of therapy prior to entry and be clinically stable. Patients with all other infections or medical illnesses must have completed therapy, or at least 14 days of maintenance therapy, prior to entry and be clinically stable (restrictions do not apply to oral and vaginal candidiasis, mucocutaneous herpes simplex infection, and minor skin conditions).]
  • Risk Behavior:
  • Excluded:
  • Possible current substance abuse that could prevent compliance with the study medication.

Trial locations and contacts

80 sites in 4 countries.

80 sites in 4 countries

United States63 sites

  • Akron City Hospital

    Akron, Ohio, 44304

  • Emory Univ

    Atlanta, Georgia, 30308

  • Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr

    Atlanta, Georgia, 303652225

  • State of MD Div of Corrections / Johns Hopkins Univ Hosp

    Baltimore, Maryland, 212052196

  • 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

  • SUNY / Erie County Med Ctr at Buffalo

    Buffalo, New York, 14215

  • 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 Kentucky Lexington

    Cincinnati, Ohio, 45267

  • Case Western Reserve Univ

    Cleveland, Ohio, 44106

  • MetroHealth Med Ctr

    Cleveland, Ohio, 441091998

  • Ohio State Univ Hosp Clinic

    Columbus, Ohio, 432101228

  • Univ of Colorado Health Sciences Ctr

    Denver, Colorado, 80262

  • Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • Univ of Texas Galveston

    Galveston, Texas, 775550435

  • Moses H Cone Memorial Hosp

    Greensboro, North Carolina, 27401

  • Milton S Hershey Med Ctr

    Hershey, Pennsylvania, 170330850

  • Univ of Hawaii

    Honolulu, Hawaii, 96816

  • Indiana Univ Hosp

    Indianapolis, Indiana, 462025250

  • Division of Inf Diseases/ Indiana Univ Hosp

    Indianapolis, Indiana, 46202

  • Methodist Hosp of Indiana / Life Care Clinic

    Indianapolis, Indiana, 46202

  • Univ of Iowa Hosp and Clinic

    Iowa City, Iowa, 52242

  • Univ of Southern California / LA County USC Med Ctr

    Los Angeles, California, 900331079

  • UCLA CARE Ctr

    Los Angeles, California, 90095

  • Willow Clinic

    Menlo Park, California, 94025

  • Univ of Miami School of Medicine

    Miami, Florida, 331361013

  • Univ of Minnesota

    Minneapolis, Minnesota, 55455

  • Charity Hosp / Tulane Univ Med School

    New Orleans, Louisiana, 70112

  • Tulane Med Ctr Hosp

    New Orleans, Louisiana, 70112

  • Tulane Univ School of Medicine

    New Orleans, Louisiana, 70112

  • Beth Israel Med Ctr

    New York, New York, 10003

  • Manhattan Veterans Administration / New York Univ Med Ctr

    New York, New York, 10016

  • Chelsea Ctr

    New York, New York, 10021

  • 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

  • Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Univ of Nebraska Med Ctr

    Omaha, Nebraska, 681985130

  • Philadelphia Veterans Administration Med Ctr

    Philadelphia, Pennsylvania, 19104

  • Univ of Pennsylvania at Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Univ of Pittsburgh Med Ctr

    Pittsburgh, Pennsylvania, 15213

  • St Mary's Hosp (Univ of Rochester/Infectious Diseases)

    Rochester, New York, 14642

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • 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

  • Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

    San Jose, California, 951282699

  • Marin County Specialty Clinic

    San Rafael, California, 94903

  • Univ of Washington

    Seattle, Washington, 98104

  • St Louis Regional Hosp / St Louis Regional Med Ctr

    St Louis, Missouri, 63112

  • San Mateo AIDS Program / Stanford Univ

    Stanford, California, 943055107

  • Stanford Univ Med Ctr

    Stanford, California, 943055107

  • Harbor UCLA Med Ctr

    Torrance, California, 90502

  • Georgetown Univ Hosp

    Washington D.C., District of Columbia, 20037

  • Howard Univ

    Washington D.C., District of Columbia, 20059

  • Julio Arroyo

    West Columbia, South Carolina, 29169

Other trials in United States

Italy14 sites

  • Azienda Ospedaliera Umberto I

    Ancona

  • Ospedale S Orsola

    Bologna

  • Spedali Civili - Carosi

    Brescia

  • Spedali Civili Cadeo

    Brescia

  • Archispedale S Anna

    Ferrara

  • Universita di Genova

    Genova

  • Ospedale Luigi Cacco Moroni

    Milan

  • Ospedale Luigi Sacco Cargnel

    Milan

  • Azienda Ospedaliera di Parma

    Parma

  • IRCCS Policlinico S Matteo Filice

    Pavia

  • IRCCS Policlinico S Matteo Minoli

    Pavia

  • Archispedale S Maria Nuova

    Reggio Emilia

  • Universita di Roma - Delia

    Roma

  • Ospedale Civile Maggiore

    Verona

Other trials in Italy

Location not given2 sites

  • Azienda USL di Piacenza

  • Francesco Leoncini

Puerto Rico1 site

  • Univ of Puerto Rico

    San Juan, 009365067

Other trials in Puerto Rico

About this study

Official title: Study of Protease Inhibitor and/or Non-Nucleoside Reverse Transcriptase Inhibitor With Dual Nucleosides in Initial Therapy of HIV Infection

The purpose of this study is to compare the effectiveness of various combinations of anti-HIV drugs in HIV-positive men and women. Patients receive specific combinations of 3 or 4 of the following 6 drugs: didanosine (ddI), stavudine (d4T) efavirenz (EFV), nelfinavir (NFV), lamivudine (3TC), or zidovudine (ZDV).

Anti-HIV therapy is effective in preventing the spread of HIV in the body. However, patients often experience unpleasant side effects and have difficulties following the dosing schedule. This study looks for combinations of anti-HIV drugs ("cocktails") which will be the most effective with the fewest problems.

Read the detailed description

Highly active antiretroviral therapy, though effective in the suppression of HIV proliferation, is often complicated by difficulties with adherence and drug toxicity. Various combinations of highly active antiretroviral therapy exist; all have proved efficacious in related trials. The question addressed in this trial is which combination of antiretroviral "cocktails" provides the single greatest advantage in preventing the spread of HIV in the body. In effect, which therapy provides the greatest benefit with the fewest complications.

Step 1: Patients are randomized to 1 of 6 arms:

Arm A: didanosine (ddI), stavudine (d4T), efavirenz (EFV), and nelfinavir (NFV) placebo.

Arm B: ddI, d4T, EFV placebo, and NFV. Arm C: lamivudine (3TC)/zidovudine (ZDV), EFV, and NFV placebo. Arm D: 3TC/ZDV, EFV placebo, and NFV. Arm E: ddI, d4T, EFV, and NFV. Arm F: 3TC/ZDV, EFV, and NFV. Patients with virologic failure on 2 successive measurements or study-drug intolerance discontinue their randomized study therapy and proceed to Step 2. [AS PER AMENDMENT 7/5/00: Patients must switch regimens as soon as possible after confirmation of virologic failure to prevent development of drug resistance.]

Step 2:

Arm A: Patients receive treatment as in Arm D of Step 1. Arm B: Patients receive treatment as in Arm C of Step 1. Arm C: Patients receive treatment as in Arm B of Step 1. Arm D: Patients receive treatment as in Arm A of Step 1. Arms A, B, C, and D: Patients who fail Step 2 treatment proceed to Step 3. Arms E and F: Patients with virologic failure on Step 1 proceed immediately to Step 3.

Step 3 (salvage therapy):

Arm A, B, C, and D: Patients receive indinavir (IDV), amprenavir (APV), ddI, and hydroxyurea (HU).

[AS PER AMENDMENT 7/5/00: Patients now receive treatment on Regimen 1, 2, 3, 4, 5, or 6. Regimen 1 consists of IDV, ritonavir (RTV), ddI, and HU. Regimen 2 consists of APV, RTV, ddI, and HU. Regimen 3 consists of IDV, RTV, abacavir (ABC), and 3TC/ZDV. Regimen 4 consists of APV, RTV, ABC, and 3TC/ZDV. Regimen 5 consists of IDV, RTV, ABC, d4T, and 3TC. Regimen 6 consists of APV, RTV, ABC, d4T, and 3TC.] Arm E: Patients receive IDV, APV, and 3TC/ZDV. [AS PER AMENDMENT 7/5/00: Patients now receive treatment on Regimen 7 or 8. Regimen 7 consists of IDV, RTV, and 3TC/ZDV. Regimen 8 consists of APV, RTV, and 3TC/ZDV.] Arm F: Patients receive IDV, APV, ddI, and d4T. [AS PER AMENDMENT 7/5/00: Patients now receive treatment on Regimen 9 or 10. Regimen 9 consists of IDV, RTV, ddI, and d4T. Regimen 10 consists of APV, RTV, ddI, and d4T.] [AS PER AMENDMENT 7/5/00: Patients already enrolled in Step 3 before site registration to Version 4.0 of this protocol have the option of receiving 1 of the appropriate new Step 3 regimens as outlined above or staying on their originally assigned Step 3 therapy.] [AS PER AMENDMENT 3/21/01: If virologic failure on Step 1 or 2 is confirmed, then HIV-1 RNA genotype resistance testing (in real-time, if possible) is performed. Patients receive 1 of the Step 3 drug regimens based on the results of the resistance testing.] Patients may co-enroll in metabolic, pharmacologic, immunologic, or adherence substudies.

Conditions
HIV Infections
Being tested
Indinavir sulfate, Lamivudine/Zidovudine, Ritonavir, Hydroxyurea, Abacavir sulfate
Keywords
HIV Protease Inhibitors, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Medical subject headings
HIV Infections

What participants receive

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

  • Indinavir sulfateDrug

  • Lamivudine/ZidovudineDrug

  • RitonavirDrug

  • HydroxyureaDrug

  • Abacavir sulfateDrug

  • AmprenavirDrug

  • Nelfinavir mesylateDrug

  • EfavirenzDrug

  • LamivudineDrug

  • StavudineDrug

  • ZidovudineDrug

  • DidanosineDrug

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 2002

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 N/A
Primary purpose
Treatment
Masking
Double blind
Enrolment
900 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000919
Sponsor's protocol ID
ACTG 384
Other IDs
11343, AACTG A5005s, AACTG A5006s, AACTG A5007s, AACTG A5031s, AACTG 731
Status last verified
Jun 2012
First submitted
2 Nov 1999
Last updated
7 Jun 2012
Results posted
No

Publications

  • Smeaton LM, DeGruttola V, Robbins GK, Shafer RW. ACTG (AIDS Clinical Trials Group) 384: a strategy trial comparing consecutive treatments for HIV-1. Control Clin Trials. 2001 Apr;22(2):142-59. doi: 10.1016/s0197-2456(00)00126-4.

    PubMed 11306153

  • Dube MP, Zackin R, Tebas P, et al. Prospective study of regional body composition in antiretroviral-naive subjects randomized to receive zidovudine+lamivudine or didanosine+stavudine combined with nelfinavir, efavirenz, or both: A5005s, a substudy of ACTG 384. Antiviral Ther. 2002;7:L18. Abstract 27.

  • Smith PF, Robbins G, Shafer R, Wu H, Yu S, Hirsch M, Merigan T, Morse GD, ACTG 384 Study Team. Effect of Efavirenz on the Pharmacokinetics of Nelfinavir and M8 in Naïve, HIV-infected Patients Receiving Long-term HAART Therapy. 10th Conference on Retroviruses and Oppurtunistic Infections. Feb 2003. Abstract 148.

  • Shafer RW, Smeaton LM, Robbins GK, De Gruttola V, Snyder SW, D'Aquila RT, Johnson VA, Morse GD, Nokta MA, Martinez AI, Gripshover BM, Kaul P, Haubrich R, Swingle M, McCarty SD, Vella S, Hirsch MS, Merigan TC; AIDS Clinical Trials Group 384 Team. Comparison of four-drug regimens and pairs of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med. 2003 Dec 11;349(24):2304-15. doi: 10.1056/NEJMoa030265.

    PubMed 14668456

  • Robbins GK, De Gruttola V, Shafer RW, Smeaton LM, Snyder SW, Pettinelli C, Dube MP, Fischl MA, Pollard RB, Delapenha R, Gedeon L, van der Horst C, Murphy RL, Becker MI, D'Aquila RT, Vella S, Merigan TC, Hirsch MS; AIDS Clinical Trials Group 384 Team. Comparison of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med. 2003 Dec 11;349(24):2293-303. doi: 10.1056/NEJMoa030264.

    PubMed 14668455

  • Reynolds NR, Testa MA, Marc LG, Chesney MA, Neidig JL, Smith SR, Vella S, Robbins GK; Protocol Teams of ACTG 384, ACTG 731 and A5031s. Factors influencing medication adherence beliefs and self-efficacy in persons naive to antiretroviral therapy: a multicenter, cross-sectional study. AIDS Behav. 2004 Jun;8(2):141-50. doi: 10.1023/B:AIBE.0000030245.52406.bb.

    PubMed 15187476

  • Hulgan T, Haas DW, Haines JL, Ritchie MD, Robbins GK, Shafer RW, Clifford DB, Kallianpur AR, Summar M, Canter JA. Mitochondrial haplogroups and peripheral neuropathy during antiretroviral therapy: an adult AIDS clinical trials group study. AIDS. 2005 Sep 2;19(13):1341-9. doi: 10.1097/01.aids.0000180786.02930.a1.

    PubMed 16103764

  • Smith PF, Robbins GK, Shafer RW, Wu H, Yu S, Hirsch MS, Merigan TC, Park JG, Forrest A, Fischl MA, Morse GD; ACTG 384-5006 Team. Pharmacokinetics of nelfinavir and efavirenz in antiretroviral-naive, human immunodeficiency virus-infected subjects when administered alone or in combination with nucleoside analog reverse transcriptase inhibitors. Antimicrob Agents Chemother. 2005 Aug;49(8):3558-61. doi: 10.1128/AAC.49.8.3558-3561.2005.

    PubMed 16048984

  • Haas DW, Smeaton LM, Shafer RW, Robbins GK, Morse GD, Labbe L, Wilkinson GR, Clifford DB, D'Aquila RT, De Gruttola V, Pollard RB, Merigan TC, Hirsch MS, George AL Jr, Donahue JP, Kim RB. Pharmacogenetics of long-term responses to antiretroviral regimens containing Efavirenz and/or Nelfinavir: an Adult Aids Clinical Trials Group Study. J Infect Dis. 2005 Dec 1;192(11):1931-42. doi: 10.1086/497610. Epub 2005 Nov 1.

    PubMed 16267764

  • Gandhi RT, Spritzler J, Chan E, Asmuth DM, Rodriguez B, Merigan TC, Hirsch MS, Shafer RW, Robbins GK, Pollard RB; ACTG 384 Team. Effect of baseline- and treatment-related factors on immunologic recovery after initiation of antiretroviral therapy in HIV-1-positive subjects: results from ACTG 384. J Acquir Immune Defic Syndr. 2006 Aug 1;42(4):426-34. doi: 10.1097/01.qai.0000226789.51992.3f.

    PubMed 16810109

  • Marc LG, Testa MA, Walker AM, Robbins GK, Shafer RW, Anderson NB, Berkman LF; ACTG Data Analysis Concept Sheet Study Team. Educational attainment and response to HAART during initial therapy for HIV-1 infection. J Psychosom Res. 2007 Aug;63(2):207-16. doi: 10.1016/j.jpsychores.2007.04.009.

    PubMed 17662759

  • Li B, Veturi Y, Verma A, Bradford Y, Daar ES, Gulick RM, Riddler SA, Robbins GK, Lennox JL, Haas DW, Ritchie MD. Tissue specificity-aware TWAS (TSA-TWAS) framework identifies novel associations with metabolic, immunologic, and virologic traits in HIV-positive adults. PLoS Genet. 2021 Apr 26;17(4):e1009464. doi: 10.1371/journal.pgen.1009464. eCollection 2021 Apr.

    PubMed 33901188

  • Lok JJ, Hunt PW, Collier AC, Benson CA, Witt MD, Luque AE, Deeks SG, Bosch RJ. The impact of age on the prognostic capacity of CD8+ T-cell activation during suppressive antiretroviral therapy. AIDS. 2013 Aug 24;27(13):2101-10. doi: 10.1097/QAD.0b013e32836191b1.

    PubMed 24326304

  • Lok JJ, Bosch RJ, Benson CA, Collier AC, Robbins GK, Shafer RW, Hughes MD; ALLRT team. Long-term increase in CD4+ T-cell counts during combination antiretroviral therapy for HIV-1 infection. AIDS. 2010 Jul 31;24(12):1867-76. doi: 10.1097/QAD.0b013e32833adbcf.

    PubMed 20467286

Questions about this trial

What is this clinical trial studying?

A study testing Indinavir sulfate, Lamivudine/Zidovudine and Ritonavir in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 80 sites in 4 countries.

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 40 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Italy, Puerto Rico. 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?

On the ClinicalTrials.gov record for NCT00000919, which also lists 14 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 7 Jun 2012.

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