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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001067

Collaborator

(none)

105

Enrollment

Locations

8.1

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: Lamivudine Drug: Stavudine Drug: Zidovudine	Phase 2

Detailed Description

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).

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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

Actual Study Completion Date :

Nov 1, 1997

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Therapeutics CRS	Birmingham	Alabama	United States	35294
2	Stanford CRS	Palo Alto	California	United States	94305
3	Ucsd, Avrc Crs	San Diego	California	United States	92103
4	Howard University Hosp., Div. of Infectious Diseases, ACTU	Washington	District of Columbia	United States	20059
5	The Ponce de Leon Ctr. CRS	Atlanta	Georgia	United States
6	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland	United States	21287
7	Washington U CRS	Saint Louis	Missouri	United States	63110
8	St. Louis ConnectCare, Infectious Diseases Clinic	Saint Louis	Missouri	United States	63112
9	Beth Israel Med. Ctr. (Mt. Sinai)	New York	New York	United States	10003
10	NYU Med. Ctr., Dept. of Medicine	New York	New York	United States	10016
11	Unc Aids Crs	Chapel Hill	North Carolina	United States	27599
12	The Ohio State Univ. AIDS CRS	Columbus	Ohio	United States	43210
13	Puerto Rico-AIDS CRS	San Juan		Puerto Rico