Completed

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

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What is being tested

Data Collection

Who is being recruted

Blood-Borne Infections
+11

+ Urogenital Diseases
+ Genital Diseases
Over 12 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

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).

Official TitleA 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 
NCT00001067
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
105 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 12 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Blood-Borne Infections
Urogenital Diseases
Genital Diseases
Communicable Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Lentivirus Infections
Criteria

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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 13 locations
Suspended
Alabama Therapeutics CRSBirmingham, United StatesSee the location
Suspended
Stanford CRSPalo Alto, United States
Suspended
Ucsd, Avrc CrsSan Diego, United States
Suspended
Howard University Hosp., Div. of Infectious Diseases, ACTUWashington, United States

Completed13 Study Centers
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