The Effectiveness of Three Drug Combinations in HIV-Infected Patients Who Have Taken Zidovudine for More Than 12 Weeks
A Phase II Randomized Study of the Virologic and Immunologic Effects of d4T vs Zidovudine Plus d4T vs Zidovudine Plus Ddl in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and Greater Than 12 Weeks Zidovudine Experience
2 other identifiers
interventional
200
2 countries
33
Brief Summary
To compare the effect of stavudine (d4T) alone or with zidovudine (AZT) versus didanosine (ddI) alone or with AZT on CD4 counts, HIV RNA levels, and viral load in HIV-infected patients \[AS PER AMENDMENT 3/21/97: To compare the effects of d4T alone versus ddI alone versus AZT plus ddI\]. To compare the safety of d4T/AZT. AS PER AMENDMENT 3/21/97: To evaluate the pharmacokinetic interactions of AZT and d4T both at an extracellular and intracellular level. Although AZT and ddI can delay the advancement of HIV disease, the benefit of either of these drugs has proven to be only temporary. d4T, a new nucleoside analog with a favorable toxicity profile and demonstrated activity against HIV, offers an additional therapeutic option. It is reasonably assumed that the benefit of an antiretroviral agent in terms of delaying clinical disease progression is directly related to its ability to achieve and sustain viral suppression; thus, this study measures effects on viral load and CD4 count.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
November 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Required for patients whose CD4 count falls below 200 cells/mm3:
- PCP prophylaxis with TMP/SMX, aerosolized pentamidine, or dapsone.
- Allowed:
- Atovaquone, IV pentamidine, trimethoprim-dapsone, clindamycin-primaquine, trimetrexate, or TMP/SMX for acute PCP.
- Topical antifungals, clotrimazole, ketoconazole, fluconazole, and amphotericin B for mucosal and esophageal candidiasis.
- Itraconazole.
- Amphotericin B.
- Rifabutin.
- Isoniazid.
- Pyrazinamide.
- Clofazimine.
- Clarithromycin.
- Azithromycin.
- Ethambutol.
- +28 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malignancy requiring systemic cytotoxic chemotherapy.
- Serious underlying medical condition other than HIV that would reduce life expectancy to \< 2 years.
- Concurrent Medication:
- Excluded:
- Antiretrovirals other than study drugs.
- Foscarnet.
- Patients with the following prior conditions are excluded:
- Unexplained temperature \>= 38.5 C for 7 days or chronic diarrhea (\>= three stools daily) for 15 days, if occurring within 30 days prior to study entry.
- History of acute or chronic pancreatitis.
- History of grade 2 or higher peripheral neuropathy.
- History of grade 3 or worse intolerance to 500-600 mg/day AZT.
- Prior Medication:
- Excluded:
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
UCLA CARE Center CRS
Los Angeles, California, 90095, United States
Stanford CRS
Palo Alto, California, 94115, United States
Ucsd, Avrc Crs
San Diego, California, 92103, United States
Ucsf Aids Crs
San Francisco, California, 94110, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502, United States
University of Colorado Hospital CRS
Aurora, Colorado, 80262, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20010, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209, United States
Univ. of Miami AIDS CRS
Miami, Florida, 33136, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Northwestern University CRS
Chicago, Illinois, 60611, United States
Cook County Hosp. CORE Ctr.
Chicago, Illinois, 60612, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Weiss Memorial Hosp.
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Indiana Univ. School of Medicine, Wishard Memorial
Indianapolis, Indiana, 46202, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202, United States
Tulane Hemophilia Treatment Ctr.
New Orleans, Louisiana, 70112, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114, United States
Bmc Actg Crs
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, 02215, United States
Hennepin County Med. Ctr., Div. of Infectious Diseases
Minneapolis, Minnesota, 55415, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, United States
St. Louis ConnectCare, Infectious Diseases Clinic
St Louis, Missouri, 63112, United States
Washington U CRS
St Louis, Missouri, United States
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, 11203, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 43210, United States
University of Washington AIDS CRS
Seattle, Washington, 98122, United States
San Juan City Hosp. PR NICHD CRS
San Juan, 00936, Puerto Rico
Puerto Rico-AIDS CRS
San Juan, Puerto Rico
Related Publications (6)
d4T+AZT--unexpected CD4 drop seen in study. AIDS Treat News. 1996 Dec 20;(No 261):1.
PMID: 11364024BACKGROUNDShaefer M, Hardy WD, Shaker-Irwin L, Williams V, Maude C, Thommes J, Graham N. HIV viral load response in subjects switched from zidovudine (ZDV)-containing to stavudine (D4T)-containing regimens in the Pacific Oaks Population Study (POPS). Int Conf AIDS. 1998;12:57 (abstract no 12228)
BACKGROUNDHavlir DV, Friedland G, Pollard R, Tierney C, Smeaton L, Fox L, Richman DD. Combination zidovudine (ZDV) and stavudine (d4T) therapy versus other nucleosides: report of two randomized trials (ACTG 290 and 298). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:79 (abstract no 2)
BACKGROUNDCadman J. 2, 4, 6, 8, who's afraid to phosphorylate? GMHC Treat Issues. 1998 Feb;12(2):6-8.
PMID: 11365218BACKGROUNDHavlir DV, Tierney C, Friedland GH, Pollard RB, Smeaton L, Sommadossi JP, Fox L, Kessler H, Fife KH, Richman DD. In vivo antagonism with zidovudine plus stavudine combination therapy. J Infect Dis. 2000 Jul;182(1):321-5. doi: 10.1086/315683. Epub 2000 Jul 6.
PMID: 10882616BACKGROUNDSommadossi JP, Zhou XJ, Moore J, Havlir DV, Friedland G, Tierney C, Smeaton L, Fox L, Richman D, Pollard R. Impairment of stavudine (d4T) phosphorylation in patients receiving a combination of zidovudine (ZDV) and d4T (ACTG 290). Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:79 (abstract no 3)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Havlir D
- STUDY CHAIR
Richman D
- STUDY CHAIR
Pollard R
- STUDY CHAIR
Friedland G