The Effectiveness of Three Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Never Used Anti-HIV Drugs

HIV Infections Clinical Trial

Official title:

A Phase II Randomized Study of the Virologic and Immunologic Effects of Zidovudine Plus Lamivudine (3TC) Versus d4T Versus Zidovudine Plus d4T in HIV-Infected Patients With CD4 Cell Counts Between 300-600/mm3 and No Previous Nucleoside Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001067
• Other study ID #: ACTG 298
• Secondary ID: 11274
• Status: Completed
• Phase: Phase 2
• Est. completion date: November 1997

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine drug efficacy and safety in HIV-infected patients treated with zidovudine ( AZT ) versus stavudine ( d4T ) versus both drugs. Also, to compare short- and long-term changes in magnitude of HIV RNA over time.

Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.

Description:

Asymptomatic patients with CD4 counts over 300 cells/mm3 are more likely to tolerate any of the nucleoside analogs. d4T, with a favorable toxicity profile and demonstrated anti-HIV activity in previous studies, provides an additional therapeutic option.

Patients are randomized to receive d4T alone, AZT alone, or both in combination for at least 12 weeks. After week 12, 3TC is added to the combination arm. Treatment continues for up to 48 weeks (was a total of 48 weeks, amended 3/26/96).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 1997
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Required:

• TMP / SMX, aerosolized pentamidine, or dapsone for PCP prophylaxis.

Allowed:

• Atovaquone.

• IV pentamidine.

• TMP / SMX.

• Trimetrexate.

• Trimethoprim-dapsone.

• Clindamycin-primaquine.

• Topical antifungals.

• Clotrimazole.

• Ketoconazole.

• Fluconazole.

• Amphotericin B.

• Itraconazole.

• Rifabutin.

• Isoniazid.

• Pyrazinamide.

• Clofazimine.

• Clarithromycin.

• Azithromycin.

• Ethambutol.

• Amikacin.

• Ciprofloxacin.

• Ofloxacin.

• Pyrimethamine.

• Sulfadiazine.

• Clindamycin.

• Filgrastim ( G-CSF ).

• Up to 1000 mg/day acyclovir.

• Erythropoietin.

• Antibiotics.

• Antipyretics.

• Analgesics.

• Antiemetics.

• Rifampin.

Concurrent Treatment:

Allowed:

• Local radiation therapy.

Patients must have:

• HIV infection.

• CD4 count 300 - 600 cells/mm3.

• NO history of AIDS.

• NO active opportunistic infection.

• NO prior nucleoside therapy.

• Life expectancy at least 2 years.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Serious underlying medical condition other than HIV such that life expectancy is less than 2 years.

• Malignancy requiring systemic cytotoxic chemotherapy.

• Active grade 2 or worse peripheral neuropathy.

Concurrent Medication:

Excluded:

• Antiretrovirals other than study drugs.

• Systemic cytotoxic chemotherapy.

• Foscarnet.

Patients with the following prior conditions are excluded:

• Chronic diarrhea defined as three or more stools per day for 15 days, within 30 days prior to study entry.

• Unexplained temperature >= 38.5 C for any 7 days within 30 days prior to study entry.

• Active participation in other experimental therapy within 30 days prior to study entry.

Prior Medication:

Excluded:

• Prior nucleoside antiretrovirals of 1 week or longer duration.

• Any antiretroviral within 90 days prior to study entry.

• Non-nucleoside reverse transcriptase inhibitors and protease inhibitors within 30 days prior to study entry.

• Biologic response modifiers such as IL-2 and interferon within 30 days prior to study entry.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lamivudine

• Stavudine

• Zidovudine

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico-AIDS CRS	San Juan
United States	The Ponce de Leon Ctr. CRS	Atlanta	Georgia
United States	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland
United States	Alabama Therapeutics CRS	Birmingham	Alabama
United States	Unc Aids Crs	Chapel Hill	North Carolina
United States	The Ohio State Univ. AIDS CRS	Columbus	Ohio
United States	Beth Israel Med. Ctr. (Mt. Sinai)	New York	New York
United States	NYU Med. Ctr., Dept. of Medicine	New York	New York
United States	Stanford CRS	Palo Alto	California
United States	St. Louis ConnectCare, Infectious Diseases Clinic	Saint Louis	Missouri
United States	Washington U CRS	Saint Louis	Missouri
United States	Ucsd, Avrc Crs	San Diego	California
United States	Howard University Hosp., Div. of Infectious Diseases, ACTU	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (3)

Cadman J. 2, 4, 6, 8, who's afraid to phosphorylate? GMHC Treat Issues. 1998 Feb;12(2):6-8. — View Citation

Havlir 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)

Pollard RB, Tierney C, Havlir D, Tebas P, Fox L, Smeaton L, Richman D, Friedland GH. A phase II randomized study of the virologic and immunologic effect of zidovudine + stavudine versus stavudine alone and zidovudine + lamivudine in patients with >300 CD4 cells who were antiretroviral naive (ACTG 298). AIDS Res Hum Retroviruses. 2002 Jul 1;18(10):699-704. — View Citation