## Protocol Section
### Identification Module
**NCT ID:** NCT00000779

**Brief Title:** A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3

**Official Title:** A Phase I Comparative Blinded Trial of Several HIV-1 Derived Immunogens in Infected Individuals With >= 500 CD4 Cells/mm3

#### Organization Study ID Info
**ID:** ACTG 214
#### Organization
**Class:** NIH
**Full Name:** National Institute of Allergy and Infectious Diseases (NIAID)
#### Secondary ID Infos
**Domain:** DAIDS ES Registry Number
**ID:** 11191
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 1996-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-11-04

**Type:** ACTUAL

**Last Update Submit Date:** 2021-10-27

**Overall Status:** COMPLETED

**Status Verified Date:** 2021-10

#### Study First Post Date
**Date:** 2001-08-31
**Type:** ESTIMATED
**Study First Submit Date:** 1999-11-02
**Study First Submit QC Date:** 2001-08-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NIH

**Name:** National Institute of Allergy and Infectious Diseases (NIAID)

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** PRIMARY: To compare the immunogenicity and safety of each of several HIV-1 derived immunogens versus control in HIV-infected individuals with CD4 counts greater than or equal to 500 cells/mm3.

SECONDARY: To determine whether significant advantages to any one vaccine exist.

Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.

**Detailed Description:** Before large clinical trials of anti-HIV vaccines are undertaken, it is important to determine whether there are significant advantages to any one of the vaccines currently offered for such studies.

Patients are randomized to receive one of four vaccines or one of two placebo controls. The vaccines are: rgp 120/HIV-1IIIB, rgp 120/HIV-1MN, rgp 120/HIV-1SF, and env 2-3. The two control immunogens are aluminum hydroxide (alum) and BIOCINE Placebo Vaccine 2 (MF-59 adjuvant emulsion in citrate buffer). Patients are vaccinated at weeks 0, 4, 8, 12, 16, 20, 28, and 36. If significant benefit is seen among vaccine patients, then placebo patients may receive vaccination with one of the immunogens producing an immune response.

### Conditions Module

**Conditions:**

- HIV Infections

**Keywords:**

- Vaccines, Synthetic

- HIV-1

- Adjuvants, Immunologic

- AIDS-Related Complex

- HIV Envelope Protein gp120

- AIDS Vaccines

- HIV Therapeutic Vaccine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 130

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Aluminum hydroxide

**Type:** BIOLOGICAL

#### Intervention 2

**Name:** MF59

**Type:** BIOLOGICAL

#### Intervention 3

**Name:** rgp120/HIV-1IIIB

**Type:** BIOLOGICAL

#### Intervention 4

**Name:** rgp120/HIV-1MN

**Type:** BIOLOGICAL

#### Intervention 5

**Name:** rgp120/HIV-1 SF-2

**Type:** BIOLOGICAL

#### Intervention 6

**Name:** Env 2-3

**Type:** BIOLOGICAL

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria

Concurrent Medication:

Allowed:

* Short-term nonsteroidal anti-inflammatory therapy.

Patients must have:

* HIV seropositivity.
* CD4 count \>= 500 cells/mm3.
* Successful establishment of EBV-transformed B-cell lines at study entry.
* Consent of parent or guardian if \< 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Suspected or known allergies to any vaccine components.
* Medical contraindication.
* Problem with compliance.

Concurrent Medication:

Excluded:

* Antiretroviral therapy (e.g., AZT, ddI, or ddC).
* Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin).
* Parenteral therapies (including SC allergy sensitization).
* Other investigational HIV drugs or therapies.

Prior Medication:

Excluded:

* Any prior vaccinations against HIV.
* Antiretroviral therapy (e.g., AZT, ddI, or ddC) within the past 6 months.
* Agents with putative immunomodulating activity (e.g., interferon, steroids, hematopoietin) within the past 3 months.
* Parenteral therapies (including SC allergy sensitization) within the past 3 months.
* Other investigational HIV drugs or therapies within the past 3 months.

**Minimum Age:** 13 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** UCLA CARE Center CRS

**State:** California

**Location 2:**

**City:** Palo Alto

**Country:** United States

**Facility:** Stanford CRS

**State:** California

**Zip:** 94115

**Location 3:**

**City:** San Jose

**Country:** United States

**Facility:** Santa Clara Valley Med. Ctr.

**State:** California

**Zip:** 951282699

**Location 4:**

**City:** San Mateo

**Country:** United States

**Facility:** San Mateo County AIDS Program

**State:** California

**Zip:** 943055107

**Location 5:**

**City:** Aurora

**Country:** United States

**Facility:** University of Colorado Hospital CRS

**State:** Colorado

**Zip:** 80262

**Location 6:**

**City:** Boston

**Country:** United States

**Facility:** Massachusetts General Hospital ACTG CRS

**State:** Massachusetts

**Zip:** 02114

**Location 7:**

**City:** Boston

**Country:** United States

**Facility:** Bmc Actg Crs

**State:** Massachusetts

**Zip:** 02118

**Location 8:**

**City:** Boston

**Country:** United States

**Facility:** Beth Israel Deaconess Med. Ctr., ACTG CRS

**State:** Massachusetts

**Zip:** 02215

**Location 9:**

**City:** New York

**Country:** United States

**Facility:** NY Univ. HIV/AIDS CRS

**State:** New York

**Zip:** 10016

**Location 10:**

**City:** Seattle

**Country:** United States

**Facility:** University of Washington AIDS CRS

**State:** Washington

**Zip:** 981224304

#### Overall Officials

**Official 1:**

**Name:** Schooley RT

**Role:** STUDY_CHAIR

**Official 2:**

**Name:** Walker B

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Schooley RT, Spino C, Chiu S, DeGruttola V, Kuritzkes DR. Poor immunogenicity of HIV-1 envelope vaccines with alum or MF59 aduvant in HIV-infected individuals: results of two randomized trials. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:204 (abstract no 756)

**Citation:** Schooley RT, Spino C, Kuritzkes D, Walker BD, Valentine FA, Hirsch MS, Cooney E, Friedland G, Kundu S, Merigan TC Jr, McElrath MJ, Collier A, Plaeger S, Mitsuyasu R, Kahn J, Haslett P, Uherova P, deGruttola V, Chiu S, Zhang B, Jones G, Bell D, Ketter N, Twadell T, Chernoff D, Rosandich M. Two double-blinded, randomized, comparative trials of 4 human immunodeficiency virus type 1 (HIV-1) envelope vaccines in HIV-1-infected individuals across a spectrum of disease severity: AIDS Clinical Trials Groups 209 and 214. J Infect Dis. 2000 Nov;182(5):1357-64. doi: 10.1086/315860. Epub 2000 Oct 9.

**PMID:** 11023459

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000016180

- Term: Lentivirus Infections

- ID: D000012192

- Term: Retroviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: HIGH

- As Found: HIV Infections

- ID: M3735

- Name: AIDS-Related Complex

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M18640

- Name: Lentivirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15026

- Name: Retroviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015658

- Term: HIV Infections

### Intervention Browse Module - Ancestors

- ID: D000000276

- Term: Adjuvants, Immunologic

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000863

- Term: Antacids

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000005765

- Term: Gastrointestinal Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: LOW

- As Found: Unknown

- ID: M3877

- Name: Aluminum Hydroxide

- Relevance: HIGH

- As Found: Mg/kg body weight

- ID: M3628

- Name: Adjuvants, Immunologic

- Relevance: LOW

- As Found: Unknown

- ID: M35911

- Name: MF59 oil emulsion

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M4188

- Name: Antacids

- Relevance: LOW

- As Found: Unknown

- ID: M4219

- Name: Anti-Ulcer Agents

- Relevance: LOW

- As Found: Unknown

- ID: M8881

- Name: Gastrointestinal Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000536

- Term: Aluminum Hydroxide

### Misc Info Module

- Version Holder: 2024-05-24
